NCT06400784CompletedPhase 4
Hypertensive Heart Failure Treatment in SSA
The Evidence-based Treatment of Hypertensive Heart Failure in Sub-Saharan Africa: A Feasibility Study
Source: ClinicalTrials.gov · Last updated 6 May 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 50 (actual)
- First submitted
- 31 Dec 2022
- Start date
- 25 Mar 2022
- Primary completion date
- 26 Feb 2024
- Lead sponsor
- University of Abuja
- Diseases
- Heart failure
- NCT number
- NCT06400784
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 50
- From 25 Mar 2022 to the primary completion date, 26 Feb 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Evidence of heart failure from a cause other than hypertension
- coronary syndrome, unstable angina, MI, PCI, CABG, stroke, carotid endarterectomy, etc.,)
Lab values
- 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)
Other
- A cardiovascular/cerebrovascular event/intervention in the last three months (e.g., acute
- Office SBP \<100 mmHg or DBP \<70 mmHg
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Abuja Teaching Hospital Coordinator of this site? Confirm its status | Abuja | Nigeria | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.