Hypertensive Heart Failure Treatment in SSA

University of Abuja

Status and phase: Completed; Phase 4

Conditions: A Feasibility Study on Hypertensive Heart Failure Treatment

Treatments: Drug: Isosorbide Dinitrate

Study type: Interventional

Funder types: Other

Identifiers

NCT06400784

G 102642 A18971 (Other Identifier)

Uniabuja

Details and patient eligibility

About

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.

Full 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

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups, including a placebo group

Conventional HF medications plus ISDN & HYD

Active Comparator group

Description:

Will administer Isosorbide dinitrate (5mg bd) and Hydralazine (25mg bd) on top of conventional heart failure medications.

Treatment:

Drug: Isosorbide Dinitrate

Conventional HF medications plus placebo

Placebo Comparator group

Description:

We will administer placebo on top of conventional heart failure medications

Treatment:

Drug: Isosorbide Dinitrate