Hypertensive Heart Failure Treatment in SSA

NCT06400784 | Completed Phase 4 DMC

• 2 other identifiers: UniabujaG 102642 A18971
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

A Feasibility Study on Hypertensive Heart Failure Treatment

Outcome Measures

Primary Outcomes (1)

• Feasibility of the study

  Time taken to recruit the required subjects (n=50)

  18 months

Secondary Outcomes (4)

• Clinical Outcomes

  6 months

• Clinical outcomes

  6 months

• Clinical outcomes

  6 months

• Clinical outcomes

  6 months

Study Arms (2)

Conventional HF medications plus ISDN & HYD

ACTIVE COMPARATOR

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

Drug: Isosorbide Dinitrate

Conventional HF medications plus placebo

PLACEBO COMPARATOR

We will administer placebo on top of conventional heart failure medications

Drug: Isosorbide Dinitrate

Interventions

Isosorbide Dinitrate DRUG

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

Conventional HF medications plus ISDN & HYD; Conventional HF medications plus placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Abuja: lead
• University of Cambridge: collaborator

Study Sites (1)

University of Abuja Teaching Hospital

Abuja, Federal Capital Territory, 90001, Nigeria

Location

Related Publications (1)

• 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.

  BACKGROUND

MeSH Terms

Interventions

Isosorbide Dinitrate

Intervention Hierarchy (Ancestors)

Isosorbide; Sorbitol; Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates

Study Officials

• REGINA ASUKU

  CARDIOVASCULAR RESEARCH UNIT, UNIVERSITY OF ABUJA TEACHING HOSPITAL

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Parallel group, 2-arm, superiority trial.

Study Record Dates

• First Submitted: December 31, 2022
• First Posted: May 6, 2024
• Study Start: March 25, 2022
• Primary Completion: February 26, 2024
• Study Completion: March 26, 2024
• Last Updated: May 6, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

NG (1)