Hypertensive Heart Failure Treatment in SSA

NCT ID: NCT06400784

Last Updated: 2024-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-25
• Study Completion Date: 2024-03-26

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

Conditions

A Feasibility Study on Hypertensive Heart Failure Treatment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Conventional HF medications plus ISDN & HYD

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

Group Type: ACTIVE_COMPARATOR

Isosorbide Dinitrate

Intervention Type: DRUG

Isosorbide dinitrate (5mg bd) and Hydralazine (25mg bd) will be added on top of conventional heart failure medications.

Conventional HF medications plus placebo

We will administer placebo on top of conventional heart failure medications

Group Type: PLACEBO_COMPARATOR

Isosorbide Dinitrate

Intervention Type: DRUG

Isosorbide dinitrate (5mg bd) and Hydralazine (25mg bd) will be added on top of conventional heart failure medications.

Interventions

Isosorbide Dinitrate

Isosorbide dinitrate (5mg bd) and Hydralazine (25mg bd) will be added on top of conventional heart failure medications.

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Cambridge

OTHER

Sponsor Role: collaborator

University of Abuja

OTHER

Sponsor Role: lead

Responsible Party

Dr. Dike Ojji

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

REGINA ASUKU

Role: STUDY_DIRECTOR

CARDIOVASCULAR RESEARCH UNIT, UNIVERSITY OF ABUJA TEACHING HOSPITAL

Locations

University of Abuja Teaching Hospital

Abuja, Federal Capital Territory, Nigeria

Countries

Nigeria

References

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.

Reference Type: BACKGROUND

Other Identifiers

G 102642 A18971

Identifier Type: OTHER

Identifier Source: secondary_id

Uniabuja

Identifier Type: -

Identifier Source: org_study_id