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Hypertensive Heart Failure Treatment in SSA

NCT06400784 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-05-06

No results posted yet for this study

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

Interventions

DRUG

Isosorbide Dinitrate

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

Sponsors & Collaborators

Principal Investigators

  • REGINA ASUKU · CARDIOVASCULAR RESEARCH UNIT, UNIVERSITY OF ABUJA TEACHING HOSPITAL

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-25
Primary Completion
2024-02-26
Completion
2024-03-26

Countries

  • Nigeria

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06400784 on ClinicalTrials.gov