Primary care management for optimized antithrombotic treatment [PICANT]: study protocol for a cluster-randomized controlled trial

ABSTRACT: BACKGROUND: Antithrombotic treatment is a continuous therapy that is often performed in general practice and requires careful safety management. The aim of this study is to investigate whether a best practice model that applies major elements of case management, including patient education, can improve antithrombotic management in primary health care in terms of reducing major thromboembolic and bleeding events. METHODS: This 24-month cluster-randomized trial will be performed in 690 adult patients from 46 practices. The trial intervention will be a complex intervention involving general practitioners, health care assistants and patients with an indication for oral anticoagulation. To assess adherence to medication and symptoms in patients, as well as to detect complications early, health care assistants will be trained in case management and will use the Coagulation-Monitoring-List (Co-MoL) to regularly monitor patients. Patients will receive information (leaflets and a video), treatment monitoring via the Co-MoL and be motivated to perform self-management. Patients in the control group will continue to receive treatment-as-usual from their general practitioners. The primary endpoint is the combined endpoint of all thromboembolic events requiring hospitalization, and all major bleeding complications. Secondary endpoints are mortality, hospitalization, strokes, major bleeding and thromboembolic complications, severe treatment interactions, the number of adverse events, quality of anticoagulation, health-related quality of life and costs. Further secondary objectives will be investigated to explain the mechanism by which the intervention is effective: patients' assessment of chronic illness care, self-reported adherence to medication, general practitioners' and health care assistants' knowledge, patients' knowledge and satisfaction with shared decision making. Practice recruitment is expected to take place between July and December 2012. Recruitment of eligible patients will start in July 2012. Assessment will occur at three time points: baseline (T0), follow-up after 12 (T1) and after 24 months (T2). DISCUSSION: The efficacy and effectiveness of individual elements of the intervention, such as antithrombotic interventions, self-management concepts in orally anticoagulated patients and the methodological tool, case-management, have already been extensively demonstrated. This project foresees the combination of several proven instruments, as a result of which we expect to profit from a reduction in the major complications associated with antithrombotic treatment.     

Benefits and side effects of blood pressure lowering treatment: what was wrong with doxazosin in the ALLHAT?

The lowering of high blood pressure is supposed to protect target organs from hypertensive damage. The Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial was designed to compare the cardioprotective properties of three antihypertensives from different classes (lisinopril, amlodipine and doxazosin) with chlorthalidone. Despite effective blood pressure lowering and a favorable metabolic profile, the doxazosin arm of the trial had a significantly higher relative risk of cardiovascular disease and heart failure compared with the chlorthalidone arm. This article speculates on possible causes for this unexpected result and suggests that the culprit may be accentuation of the vascular effects of vasopressin, which are maximized under α-adrenergic blockade. These findings may have implications for the large number of older men who receive monotherapy with α-blockers for treatment of prostatic symptoms     

Choice of antihypertensive drug in the diabetic patient

The hypertensive patient with type 2 diabetes is especially at risk of adverse cardiovascular events. The United Kingdom Prospective Diabetes Study (UKPDS) and Hypertension Optimal Treatment (HOT) studies suggested that treatment to a lower target blood pressure resulted in better prevention of clinical disease in these patients. Most trials comparing antihypertensive drugs have shown only minimal differences between the various agents. The evidence from the trials suggests that diuretics, beta-blockers, calcium channel blockers (CCBs), angiotensin-converting enzyme (ACE) inhibitors, and the angiotensin-receptor antagonists (ARBs) will all successfully reduce adverse clinical events. The largest of the comparative hypertensive drug trials, the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT), demonstrated that a diuretic has a better hypotensive effect, and was more successful in preventing many aspects of cardiovascular disease compared with CCBs and ACE inhibitors. The importance of good blood pressure control and the general equivalence of antihypertensive drugs were again shown in the Valsartan Antihypertensive Long-term Use Evaluation (VALUE) trial, which compared an ARB with a CCB. Choice of antihypertensive agent should be individualized and guided by the presence of concomitant clinical disease and the need to protect any specific target organ system in the diabetic hypertensive. Diuretics, being potent hypotensive drugs with clearly demonstrated clinical benefit, should form part of the antihypertensive regimen of most diabetic hypertensives. ACE inhibitors and ARBs are especially useful in preventing nephropathy. Most patients will require a combination of antihypertensive drugs to achieve tight blood pressure control of under 130/80 mm Hg in the diabetic hypertensive. The clinician should concentrate on seeking this lower target blood pressure rather than be excessively concerned about which is the best antihypertensive agent.     

Interpractice audit of diagnosis and management of hypertension in primary care: educational intervention and review of medical records.

OBJECTIVE: To determine whether peer review medical audit in a primary care setting changes clinical behaviour in relation to the management of hypertension. DESIGN: Review of medical records in general practices to identify hypertensive patients followed up by assessment of the pre-educational and post-educational management of interventions. SETTING: Six general practices in north west London picked at random within defined criteria of geography and size. SUBJECTS: 740 hypertensive patients managed by 25 different general practitioners. MAIN OUTCOME MEASURES: Improved level of care in terms of better diagnosis by having at least three blood pressure readings before the start of drug treatment, better level of recordings of lifestyle parameters as shown by the level of recordings of body mass index and total lipid values, and better control of blood pressure and harm minimisation as shown by the level of recordings of urea and electrolyte values. RESULTS: Improvement was noted in the level of recordings of body mass index, total lipid concentrations, and urea and electrolyte values but not in better diagnosis or blood pressure control. CONCLUSION: Clinical behaviour of general practitioners can be changed by peer review but more complex behavioural changes which require the cooperation of the patients and cognitive actions by the general practitioners need further investigation.     

Computer assisted shared care in hypertension.

A computer assisted shared care scheme for the long term management and follow up of hypertensive patients has been developed in the Grampian Region. The scheme aims at facilitating the exchange of clinically important information between doctors and at achieving target levels of blood pressure with treatment in patients at highest risk of cardiovascular events. The shared care scheme has been well received by the local practitioners. Two hundred and fifty seven patients (18%) of 1426 patients under current long term follow up are assigned to follow up in the hospital aspect of the scheme. At the most recent visit 32% of patients in the hospital aspect and 10% of 1169 patients in the general practice aspect had blood pressure recordings above the target levels of 160/95 mm Hg. The stratification of patients formerly attending hospital clinics into grades of risk has rationalised our follow up procedures to allow the specialist resources to be freed and concentrated on those patients at highest risk and with the most complex problems. This computer assisted patient records system could be applied to other groups of high risk patients in whom long term follow up and surveillance are necessary--for example, patients with diabetes mellitus--and has implications for optimising and monitoring the delivery and outcome of care without overwhelming limited hospital resources.     

Evaluation of computer based clinical decision support system and risk chart for management of hypertension in primary care: randomised controlled trial

ObjectivesTo investigate the effect of a computer based clinical decision support system and a risk chart on absolute cardiovascular risk, blood pressure, and prescribing of cardiovascular drugs in hypertensive patients.DesignCluster randomised controlled trial.Setting27 general practices in Avon.Participants614 patients aged between 60 and 79 years with high blood pressure.InterventionsPatients were randomised to computer based clinical decision support system plus cardiovascular risk chart; cardiovascular risk chart alone; or usual care.ResultsPatients in the computer based clinical decision support system and chart only groups were no more likely to have cardiovascular risk reduced to below 10% than patients receiving usual care. Patients in the computer based clinical decision support group were more likely to have a cardiovascular risk ⩾10% than chart only patients, odds ratio 2.3 (95% confidence interval 1.1 to 4.8). The chart only group had significantly lower systolic blood pressure compared with the usual care group (difference in means −4.6 mm Hg (95% confidence interval −8.4 to −0.8)). Reduction of diastolic blood pressure did not differ between the three groups. The chart only group were twice as likely to be prescribed two classes of cardiovascular drugs and over three times as likely to be prescribed three or more classes of drugs compared with the other groups.ConclusionsThe computer based clinical decision support system did not confer any benefit in absolute risk reduction or blood pressure control and requires further development and evaluation before use in clinical care can be recommended. Use of chart guidelines are associated with a potentially important reduction in systolic blood pressure.     

Effect of eplerenone on parathyroid hormone levels in patients with primary hyperparathyroidism: a randomized, double-blind, placebo-controlled trial

ABSTRACT: BACKGROUND: Increasing evidence suggests the bidirectional interplay between parathyroid hormone and aldosterone as an important mechanism behind the increased risk of cardiovascular damage and bone disease observed in primary hyperparathyroidism. Our primary object is to assess the efficacy of the mineralocorticoid receptor-blocker eplerenone to reduce parathyroid hormone secretion in patients with parathyroid hormone excess. Methods/design Overall, 110 adult male and female patients with primary hyperparathyroidism will be randomly assigned to eplerenone (25 mg once daily for 4 weeks and 4 weeks with 50 mg once daily after dose titration] or placebo, over eight weeks. Each participant will undergo detailed clinical assessment, including anthropometric evaluation, 24-h ambulatory arterial blood pressure monitoring, echocardiography, kidney function and detailed laboratory determination of biomarkers of bone metabolism and cardiovascular disease. The study comprises the following exploratory endpoints: mean change from baseline to week eight in (1) parathyroid hormone(1--84) as the primary endpoint and (2) 24-hour systolic and diastolic ambulatory blood pressure levels, NT-pro-BNP, biomarkers of bone metabolism, 24 hours urinary protein/albumin excretion and echocardiographic parameters reflecting systolic and diastolic function as well as cardiac dimensions, as secondary endpoints. DISCUSSION: In view of the reciprocal interaction between aldosterone and parathyroid hormone and the potentially ensuing target organ damage, the EPATH trial is designed to determine whether eplerenone, compared to placebo, will effectively impact on parathyroid hormone secretion and improve cardiovascular and bone health in patients with primary hyperparathyroidism. Trial registration ISRCTN33941607.     

Individual variation between general practitioners in labelling of hypertension.

Variation in labelling of hypertension by individual general practitioners was studied during a continuous opportunistic screening programme for hypertension in a single general practice with 12 principals. All the general practitioners agreed to label as hypertensive patients with systolic pressures of greater than or equal to 200 mm Hg or diastolic pressures of greater than or equal to 110 mm Hg on three consecutive readings. The overall number of patients labelled hypertensive at the beginning of the screening programme was 505 and this rose to 801 after five years. There was a large variation in the numbers of patients recorded as hypertensive at the start of the screening period, with numbers ranging from eight to 112 for individual practitioners. The variation persisted during the screening period, with the numbers of patients detected by individual general practitioners ranging from four to 46. The average systolic and diastolic pressures recorded among these patients also varied between doctors, and only 24 out of 187 patients had their high pressures recorded on three occasions and so fully met the criteria for diagnosing hypertension. Clearly, general practitioners are following their own individual criteria in defining hypertension and taking into account factors other than just the measured blood pressure.     

Nationwide study of decisions concerning the end of life in general practice in The Netherlands.

OBJECTIVE--To gain insight into decisions made in general practice about the end of life. DESIGN--Study I: interviews with 405 physicians. Study II: analysis of death certificates with data obtained on 5197 cases in which decisions about the end of life may have been made. Study III: prospective study with doctors from study I: questionnaires used to collect information about 2257 deaths. The information was representative for all deaths in the Netherlands. RESULTS--Over two fifths of all patients in the Netherlands die at home. General practitioners took fewer decisions about the end of life than hospital doctors and doctors in nursing homes (34%, 40%, and 56% of all dying patients, respectively). Specifically, decisions to withhold or withdraw treatment to prolong life were taken less often. Euthanasia or assisted suicide, however, was performed in 3.2% of all deaths in general practice compared with 1.4% in hospital practice. In over half of the cases concerning pain relief or non-treatment general practitioners did not discuss the decision with the patient, mostly because of incapacity of the patient, but in 20% of cases for "paternalistic" reasons. Older general practitioners discussed such decisions less often with their patients. Colleagues were consulted more often if the general practitioner worked in group practice. CONCLUSION--Differences in work situation between general practitioners and hospital doctors and differences between the group of general practitioners contribute to differences in the number and type of decisions about the end of life as well as in the decision making process.     

The medical decision-making process and the family: the case of breast cancer patients and their husbands

Objectives:  The objectives of the study were (1) to assess similarities and differences between breast cancer patients and their husbands in terms of doctor-patient/spouse relationships and shared decision making; and (2) to investigate the association between breast cancer patients and husbands in terms of preference of type of doctor, doctor-patient relationship, and shared decision making regarding medical treatment.
Method:  Fifty-seven women with breast cancer, and their husbands, completed questionnaires measuring doctor-patient/spouse relationships (paternalism, autonomy), and decision making regarding medical treatment.
Results:  Patients believe they have a key role in the medical decision-making process (93%) and that the participation of their husbands, and their agreement with the decision, is important (84% and 89%, respectively). Both breast cancer patients and their husbands prefer a shared decision-making process to paternalistic or autonomy-based approaches.
Conclusion:  In contrast to legal and bioethical approaches, which focus on the patient as the primary decision maker, this study reflects a practical recognition of the role of the breast cancer patient's husband in the decision-making process. It also reflects a relational rather than an individualistic perception of patient autonomy.     

General practitioners' management of hypertension in elderly patients.

OBJECTIVE--To assess general practitioners'' attitudes to the diagnosis and management of hypertension in elderly patients. DESIGN--Postal questionnaire to all general practitioners in Leicestershire. RESULTS--360 of 451 general practitioners (80%) responded. 81% (292) reported rechecking an initially high blood pressure on two or three occasions before starting treatment, 56% (202) measured sitting blood pressure only, and just 28% (100) took sitting and standing levels. 36% (128) had no upper age limit for starting anti-hypertensive treatment; of the 58% (206) who did, the median was 80 (range 70-99) years. Blood pressure levels reported for starting treatment in patients aged 70-79 years were 180 (150-240)/106 (90-120) mm Hg. 34% of general practitioners (121) would not treat isolated systolic hypertension. The most popular first line treatment for an elderly hypertensive patient was a thiazide diuretic; only 17% of general practitioners (61) initially tried non-pharmacological methods. 34% (122) would continue anti-hypertensive treatment unchanged in the period immediately after stroke. CONCLUSIONS--The variation among general practitioners in the criteria for the measurement, diagnosis, and treatment of hypertension in elderly patients emphasises the need for clear management guidelines in this age group.     

Clinical problem solving based on the 1999 Canadian recommendations for the management of hypertension

The 1999 Canadian Recommendations for the Management of Hypertension are notable for the trends that they represent with regard to the evolution of the management of hypertension. Diagnostically, the Recommendations endorse the greater use of non-office-based measures of blood pressure control and greater emphasis on the assessment of other atherosclerotic risk factors, both when considering prognosis in hypertension and in the choice of therapy. On the treatment side of the equation, lower targets for blood pressure control have been advocated in subgroups of hypertensive patients, particularly in those with diabetes and renal disease. In conjunction with the recently published recommendations on lifestyle management, there is a greater emphasis on lifestyle modification, both as initial and adjunctive therapy in hypertension. Implicit in the recommendations for therapy is the principle that for the vast majority of hypertensive patients treated pharmacologically, practitioners should not follow a stepped-care approach. Instead, therapy should be individualized, primarily based on consideration of concurrent diseases, both cardiovascular and noncardiovascular (Tables 1 and 2). Through the consensus process, there was a general appreciation of how far we have come in the development of evidence-based recommendations for hypertension management. However, there was also an increasing appreciation of how far we have to go in effectively translating these recommendations into better blood pressure control.     

Can general practitioners use training in relaxation and management of stress to reduce mild hypertension?

To see whether general practitioners could effectively carry out training in relaxation and management of stress to reduce mild hypertension a study was carried out with a subsample of phase 2 of the Medical Research Council''s treatment of mild hypertension trial.¹ In the main mild hypertension trial patients had been receiving either an active drug or placebo for six years. In phase 2 a subsample of these patients were randomly allocated either to continue or to stop receiving the active drug or placebo. In a further subsample patients were again randomised to receive or not to receive relaxation therapy. This factorial design presented an additional opportunity to assess whether patients controlled with active drugs might have their blood pressure maintained by this behavioural therapy once drug treatment was stopped and to assess whether blood pressure might be further reduced by this therapy in patients who had been under regular medical supervision for as long as six years and who had already received non-pharmacological advice. The therapy was conducted by general practitioners in group sessions once a week for eight weeks. The training in relaxation was accompanied by galvanic skin resistance biofeedback. At one year follow up blood pressure in the relaxation subgroups was either maintained (in the group who had stopped receiving drugs) or reduced further (in the group who had continued receiving drugs and in both placebo groups), while in the control group it had increased in all the subgroups, but particularly in those who had stopped receiving drugs. Differences in changes in blood pressure between the relaxation and control groups were significant. There were five new cardiovascular events, including evidence of myocardial ischaemia in blindly coded electrocardiograms in the control group, compared with one in the treatment group.General practitioners, if motivated, can successfully apply this technique of training those with mild hypertension in relaxation and management of stress.     

Shared Decision Making in Patients with Stable Coronary Artery Disease: PCI Choice

Background

Percutaneous coronary intervention (PCI) and optimal medical therapy (OMT) are comparable, alternative therapies for many patients with stable angina; however, patients may have misconceptions regarding the impact of PCI on risk of death and myocardial infarction (MI) in stable coronary artery disease (CAD).

Methods and Results

We designed and developed a patient-centered decision aid (PCI Choice) to promote shared decision making for patients with stable CAD. The estimated benefits and risks of PCI+OMT as compared to OMT were displayed in a decision aid using pictographs with natural frequencies and text. We engaged patients, clinicians, health service researchers, and designers with over 20 successive iterations of the decision aid, which were field tested during real-world clinical encounters involving clinicians and patients. The decision aid is intended to facilitate knowledge transfer, deliberation based on patient values and preferences, and shared decision making.

Conclusions

We describe the methods and outcomes of the design and development of a decision aid (PCI Choice) to promote shared decision making between clinicians and patients regarding the choice of PCI+OMT vs. OMT for treatment of stable CAD. We will evaluate the impact of PCI Choice on patient knowledge, decisional conflict, participation in decision-making, and treatment choice in an upcoming randomized trial.     

High blood pressure. detection and treatment by general practitioners.

A questionnaire was sent to a 10% random sample of general practitioners in England and Wales on their attitudes to the detection and treatment of hypertension; 62% responded and no further inquiry was made. Their view on detection and criteria for treatment and investigations performed were considered in relation to their background. More of the older practitioners always measured blood pressure and 36% of all practitioners believed that hypertensive patients usually present with symptoms. Altogether 91% thought that strokes could be prevented by treating hypertension, and only 18% reported difficulty in keeping patients on treatment. Older practitioners preferred to measure the distolic pressure using phase five, while the younger preferred phase four. Nearly all doctors were satisfied with their current sphygmomanometers.     

Should we tell them when their blood pressure is up?

We carried out two studies to determine the effects of feedback on subsequent blood pressure and heart rate readings in subjects without significant cardiovascular abnormalities. In both studies the subjects were randomly assigned to be told that their blood pressure was normal or was high or to receive no feedback at all; 3 minutes later another reading was taken and correct feedback provided. Study 1 was done in 114 patients who attended a family practice teaching unit for an office visit; subjects taking cardioactive medication or with chronically elevated blood pressure (diastolic pressure more than 95 mm Hg) or known low pressure (diastolic pressure less than 60 mm Hg) were excluded. Half of the subjects received feedback from a nurse and the other half from a physician. We found no effect of type of feedback or type of practitioner on subsequent readings. No adaptation of diastolic blood pressure or heart rate took place, whereas a similar rest period in the laboratory consistently triggers cardiovascular adaptation. Given the field nature of the study it was not clear whether the intervention was not powerful or whether the practitioner-patient interactions diffused the effects of an otherwise powerful intervention. Therefore, a second study with the same design was carried out in a controlled laboratory setting with 61 university students who believed they were in the adaptation phase of an experimental stress protocol. The subjects did not interact with the experimenter, who provided only the initial feedback, via intercom. The findings replicated those of study 1: type of feedback had no significant effect on subsequent blood pressure levels, and all types of feedback prevented cardiovascular adaptation. We recommend that patients be allowed to rest alone for at least 10 minutes before blood pressure is measured. Our findings suggest that practitioners need not be concerned about telling normotensive or borderline hypertensive patients that their blood pressure is elevated.     

Good news—Bad press: Applied psychophysiology in cardiovascular disorders

Dysregulation in blood pressure control can occur as a result of psychological stress in either the hypertensive or hypotensive direction. Applied psychophysiological techniques incorporating biofeedback and relaxation have been shown to be efficacious in controlled studies of hypertensive patients. Electromyograph, thermal, skin conductance and direct blood pressure feedback have been utilized alone or in combination with relaxation, blood pressure monitoring, and medication. Prediction models are proposed to define what type of hypertensive is most likely to respond with significant blood pressure decrease. Neurocardiogenic syncope is a cardiovascular disorder which manifests itself as lightheadedness, dizziness, syncope, and often migraine-type headache. Preliminary indications suggest that biofeedback-assisted relaxation may also prove beneficial to patients with this syndrome.This paper was presented as a presidential address at the 27th Annual Meeting of the Association for Applied Psychophysiology and Biofeedback, Albuquerque, NM, March, 1996. I wish to thank my present and past collaborators who contributed their thoughts and enthusiams to my program of research in applied psychophysiology of cardiovascular disorders. They are G. Argueta Bernal, Ph.D., Ilona Jurek, M.D., M. Woerner, M.Ed. R. Ph., J.T. Higgins, Jr., M.D., T. Fine, M.A. LPCC, S.W. Utz, RN, Ph.D., Gerard Roberts, M.D., Blair Grubb, M.D., Michael Weaver, RN, Ph.D.     

Reducing salt intake for prevention of cardiovascular diseases in high-risk patients by advanced health education intervention (RESIP-CVD study), Northern Thailand: study protocol for a cluster randomized trial

ABSTRACT: BACKGROUND: Decreasing salt consumption can prevent cardiovascular diseases (CVD). Practically, it is difficult to promote people's awareness of daily salt intake and to change their eating habits in terms of reducing salt intake for better cardiovascular health. Health education programs visualizing daily dietary salt content and intake may promote lifestyle changes in patients at high risk of cardiovascular disease. METHODS: This is a cluster randomized trial. A total of 800 high-CVD-risk patients attending diabetes and hypertension clinics at health centers in Muang District, Chiang Rai province, Thailand, will be studied with informed consent. A health center recruiting 100 participants is a cluster, the unit of randomization. Eight clusters will be randomized into intervention and control arms and followed up for 1 year. Within the intervention clusters the following will be undertaken: (1) salt content in the daily diet will be measured and shown to study participants; (2) 24-hour salt intake will be estimated in overnight-collected urine and the results shown to the participants; (3) a dietician will assist small group health education classes in cooking meals with less salt. The primary outcome is blood pressure change at the 1-year follow-up. Secondary outcomes at the 1-year follow-up are estimated 24-hoursalt intake, incidence of CVD events and CVD death. The intention-to-treat analysis will be followed.Blood pressure and estimated 24-hour salt intake will be compared between intervention and control groups at the cluster and individual level at the 1-year follow-up. Clinical CVD events and deaths will be analyzed by time-event analysis. Retinal blood vessel calibers of CVD-risk patients will be assessed cross-sectionally. Behavioral change to reduce salt intake and the influencing factors will be determined by structured equation model (SEM). Multilevel regression analyses will be applied. Finally, the cost effectiveness of the intervention will be analyzed. DISCUSSION: This study is unique as it will recruit the individuals most vulnerable to CVD morbidity and mortality by applying the general Framingham CVD risk scoring system. Dietary salt reduction will be applied as a prioritized, community level intervention for the prevention of CVD in a developing country.Trial registrationISRCTN39416277.     

FimAsartaN proTeinuriA SusTaIned reduCtion in comparison with losartan in diabetic chronic kidney disease (FANTASTIC): study protocol for randomized controlled trial

Background

Fimasartan is the ninth angiotensin receptor blocker to be developed. However, it has not yet been evaluated for reno-protective effects in hypertensive diabetic chronic kidney disease (CKD). The target blood pressure (BP) for hypertensive diabetic CKD is also a controversial topic. This trial was designed to assess the reno-protective effects of fimasartan compared to those of losartan as a primary outcome. This study also compares the two drugs with regard to cardiovascular and renal outcomes in accordance with target systolic BP (SBP) (as secondary outcomes).

Methods

This study is a prospective, phase III, randomized, double-blind, active-controlled, non-inferiority, four-parallel group, dose-titration, multicenter trial. We recruit patients with hypertensive diabetic CKD with overt proteinuria. Participants will be randomized into four groups (1:1:1:1): fimasartan standard SBP control (SBP?<?140 mmHg); fimasartan strict SBP control (SBP?<?130 mmHg); losartan standard SBP control; and losartan strict SBP control. After 24 weeks, all individuals are treated with fimasartan for an additional 120 weeks in an open-label design, maintaining their assigned SBP control groups as randomized. The primary endpoint is the rate of change in proteinuria, which is assessed using the spot urine albumin–creatinine ratio at 24 weeks. The secondary endpoints are the cardiovascular and renal outcomes at 144 weeks compared between the strict SBP and standard SBP control groups.

Discussion

The FANTASTIC is a clinical study to provide: (1) the reno-protective effect of fimasartan; and (2) the target BP to reduce adverse outcomes in hypertensive diabetic CKD with overt proteinuria.

Trial registration

Clinicaltrials.gov, NCT02620306. Registered on 1 December 2015.

     

Community care compared with hospital outpatient care for hypertensive patients.

Three hundred and seventy-six patients with treated diastolic blood pressures of less than 105 mm Hg and no history of accelerated hypertension or renal failure were selected from among those attending the Hammersmith Hospital hypertension clinic. Their average lying treated blood pressure was 146 mm Hg systolic and 90 mm Hg diastolic and average age 56 years; 18% were black, 6% Asian, and 76% white. The patients were mostly having multiple treatment, 90% receiving a diuretic, 35% methyldopa, 33% propranolol, 18% atenolol, 9% hydrallazine, and 7% bethanidine. They were randomly allocated to either two years of further hospital outpatient care or referred back to their general practitioners. During the two years 19 (10%) of the 187 patients followed up in hospital defaulted and three had their treatment discontinued. Twelve (6%) of the 189 followed up by their general practitioners defaulted from follow-up and nine had their treatment discontinued. At the end of the trial the average lying blood pressure was 148 mm Hg systolic and 88 mm Hg diastolic in the hospital group and 149 mm Hg systolic and 90 mm Hg diastolic in the general practice group. The change in blood pressure was calculated for each individual and showed an average fall of 1.6 mm Hg in standing diastolic pressure in the hospital group and a rise of 1.4 mm Hg in the general practice group (p less than 0.05). The 90% confidence limits for a difference in standing diastolic pressure between the groups were 1 and 5 mm Hg with the pressure lower in the hospital group. General practice care was not quite as effective in controlling blood pressure as continued specialist supervision over two years in this selected group of treated outpatients with mild or moderate hypertension, but these results show that the discharge back to general practitioners of patients who are well controlled after hospital treatment is a sensible policy.