Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06400784
Status:
COMPLETED
Last Update Posted:
2024-05-06
First Post:
2022-12-31
Brief Title:
Hypertensive Heart Failure Treatment in SSA
Sponsor:
University of Abuja
Organization:
University of Abuja
Study Overview
Official Title:
The Evidence-based Treatment of Hypertensive Heart Failure in Sub-Saharan Africa A Feasibility Study
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 hydralazinenitrate 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
A previous study The Bi treatment with hydralazinenitrate 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 hydralazinenitrate 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
A previous study The Bi treatment with hydralazinenitrate 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| G 102642 A18971 | OTHER | University of Cambridge_GCFR | None |