Hypertensive Heart Failure Treatment in SSA

Phase 4

Completed

• Conditions: A Feasibility Study on Hypertensive Heart Failure Treatment
• Interventions: Drug: Isosorbide Dinitrate

• Registration Number: NCT06400784
• Lead Sponsor: University of Abuja

Brief Summary

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.

Detailed Description

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:

1. 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.

2. To determine the effect of ISDN-HYD on the following:

* Death and hospitalisation rates

* Changes in office BP

* Changes in 6MWT

* Changes in echocardiographic left ventricular ejection fraction

Study Timeline

• Study Start: 2022-03-25
• Study First Submitted: 2022-12-31
• Primary Completion: 2024-02-26
• Study Completion: 2024-03-26
• Status Verified: 2024-05
• Study First Submitted QC: 2024-05-02
• Last Update Submitted: 2024-05-02
• Study First Posted: 2024-05-06
• Last Update Posted: 2024-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional HF medications plus ISDN & HYD	Isosorbide Dinitrate	Will administer Isosorbide dinitrate (5mg bd) and Hydralazine (25mg bd) on top of conventional heart failure medications.
Conventional HF medications plus placebo	Isosorbide Dinitrate	We will administer placebo on top of conventional heart failure medications

Primary Outcome Measures

Name	Time	Method
Feasibility of the study	18 months	Time taken to recruit the required subjects (n=50)

Secondary Outcome Measures

Name	Time	Method
Clinical Outcomes	6 months	Death and hospitalisation rates
Clinical outcomes	6 months	Changes in echocardiographic left ventricular ejection fraction.

Trial Locations

Locations (1)

University of Abuja Teaching Hospital; 🇳🇬 Abuja, Federal Capital Territory, Nigeria