Clinical trial NCT06400784: Hypertensive Heart Failure Treatment in SSA
Official title: The Evidence-based Treatment of Hypertensive Heart Failure in Sub-Saharan Africa: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: A Feasibility Study on Hypertensive Heart Failure Treatment
Lead sponsor: University of Abuja
Sponsor class: OTHER
Collaborators: name: University of Cambridge
First posted: 2024-05-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel group, 2-arm, superiority trial.
Primary purpose: TREATMENT

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

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)

Primary outcomes:
measure: Feasibility of the study
timeFrame: 18 months
Secondary outcomes:
measure: Clinical Outcomes
timeFrame: 6 months
measure: Clinical outcomes
timeFrame: 6 months
measure: Clinical outcomes
timeFrame: 6 months
measure: Clinical outcomes
timeFrame: 6 months
Other outcomes:
Locations:
city: Abuja
country: Nigeria
facility: University of Abuja Teaching Hospital
state: Federal Capital Territory
Study officials:
affiliation: CARDIOVASCULAR RESEARCH UNIT, UNIVERSITY OF ABUJA TEACHING HOSPITAL
name: REGINA ASUKU
role: STUDY_DIRECTOR
References:
citation: 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.