The Evidence-based Treatment of Hypertensive Heart Failure in Sub-Saharan Africa: A Feasibility Study

Uniabuja

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.

2022-03-25

2024-02-26

2024-03-26

Completed

Early phase I

50

Inclusion Criteria: * Black male or female aged 18 years * Evidence of hypertensive heart failure * LVEF \<40% as assessed by 2D echocardiography (modified Simpson method) * Ability to provide written informed consent for participation in the study * Available for regular follow-up as outlined in the schedule of assessments 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 * twice the upper limit of normal)

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel group, 2-arm, superiority trial.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 50, 'type': 'ACTUAL'}}

2024-05-06