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| ID | Type | Description | Link |
|---|---|---|---|
| G 102642 A18971 | Other Identifier | University of Cambridge_GCFR |
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| Name | Class |
|---|---|
| University of Cambridge | OTHER |
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Even though, the African-American Heart Failure Trial (A- HeFT) demonstrated that a combination ISDN and HYD (BiDil) improved survival among African-American patients with HF, when compared to placebo, there is no trial on chronic heart failure patients secondary to hypertensive heart disease which is the commonest etiological factor for heart failure in sub-Saharan Africa.
A previous study (The Bi treatment with hydralazine/nitrate versus placebo in Africans admitted with acute Heart Failure (BAHEF) which was on acute heart failure patients with varying aetiology, was under powered as the study could not achieve the estimated sample size because of logistic issues.
We therefore are trying to determine the feasibility of a randomised, open-label, parallel group, two-arm, superiority trial of ISDN and hydralazine in patients with chronic hypertensive heart failure in sSA.
Even though, the African-American Heart Failure Trial (A- HeFT) demonstrated that a combination ISDN and HYD (BiDil) improved survival among African-American patients with HF, when compared to placebo, there is no trial on chronic heart failure patients secondary to hypertensive heart disease which is the commonest etiological factor for heart failure in sub-Saharan Africa.
A previous study (The Bi treatment with hydralazine/nitrate versus placebo in Africans admitted with acute Heart Failure (BAHEF) which was on acute heart failure patients with varying aetiology, was under powered as the study could not achieve the estimated sample size because of logistic issues.
We therefore are trying to determine the feasibility of a randomised, open-label, parallel group, two-arm, superiority trial of ISDN and hydralazine in patients with chronic hypertensive heart failure in sSA. To determine the tolerability of ISDN and hydralazine in sSA.
The secondary objectives on the other hand are:
To determine fidelity to the trial protocol and CRF by investigators when completing a trial utilising ISDN and hydralazine in patients with chronic hypertensive heart failure in sSA.
To determine the effect of ISDN-HYD on the following:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional HF medications plus ISDN & HYD | Active Comparator | Will administer Isosorbide dinitrate (5mg bd) and Hydralazine (25mg bd) on top of conventional heart failure medications. |
|
| Conventional HF medications plus placebo | Placebo Comparator | We will administer placebo on top of conventional heart failure medications |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Isosorbide Dinitrate | Drug | Isosorbide dinitrate (5mg bd) and Hydralazine (25mg bd) will be added on top of conventional heart failure medications. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of the study | Time taken to recruit the required subjects (n=50) | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Outcomes | Death and hospitalisation rates | 6 months |
| Clinical outcomes | Changes in office BP | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
Evidence of heart failure from a cause other than hypertension
A cardiovascular/cerebrovascular event/intervention in the last three months (e.g., acute
coronary syndrome, unstable angina, MI, PCI, CABG, stroke, carotid endarterectomy, etc.,)
Office SBP <100 mmHg or DBP <70 mmHg
Marked renal impairment (e.g., eGFR <45 mls/min at screening, dialysis)
Marked hepatic impairment (e.g., history of chronic liver disease, γGT/bilirubin/ALP/ALT
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| Name | Affiliation | Role |
|---|---|---|
| REGINA ASUKU | CARDIOVASCULAR RESEARCH UNIT, UNIVERSITY OF ABUJA TEACHING HOSPITAL | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Abuja Teaching Hospital | Abuja | Federal Capital Territory | 90001 | Nigeria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 1. Sliwa K, et al. Readmission and death after an acute heart failure event: predictors and outcomes in sub-Saharan Africa: results from the THESUS-HF registry. Eur Heart J 2013; 34: 3151-59. 2. Cohn JN, et al. A randomized trial of the angiotensin-receptor blocker valsartan in chronic heart failure. N Engl J Med 2001; 345: 1667-75. 3. Lapu-Bula R, et al. From hypertension to heart failure: role of nitric oxide-mediated endothelial dysfunction and emerging insights from myocardial contrast echocardiography. Am J Cardiol 2007; 99: 7D-14D. 4. Taylor AL, et al. Combination of ISDN and hydralazine in blacks with heart failure. N Engl J Med 2004; 351: 2049-57. 5. Carson, P et al. Racial differences in response to therapy for heart failure: analysis of the vasodilator-heart failure trials. Vasodilator-Heart Failure Trial Study Group. J Card Fail 1999: 5; 178-87. 6. Damasceno A, et al. The causes, treatment, and outcome of acute heart failure in 1006 Africans from 9 countries. Arch Intern Med 2012; 172: 1386-94. 7. Sliwa K, et al. Bi treatment with hydralazine/nitrates vs. placebo in Africans admitted with acute HEart Failure (BA-HEF). Eur J Heart Fail 2016; 18: 1248-58. |
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| ID | Term |
|---|---|
| D007548 | Isosorbide Dinitrate |
| ID | Term |
|---|---|
| D007547 | Isosorbide |
| D013012 | Sorbitol |
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 |
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Parallel group, 2-arm, superiority trial.
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| Clinical outcomes | Changes in 6minute walk test | 6 months |
| Clinical outcomes | Changes in echocardiographic left ventricular ejection fraction. | 6 months |
| Organic Chemicals |
| D002241 | Carbohydrates |