A Feasibility Study on Hypertensive Heart Failure Treatment
Conditions
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
Interventions
Isosorbide dinitrate (5mg bd) and Hydralazine (25mg bd) will be added on top of conventional heart failure medications.
Sponsors
University of Cambridge
University of Abuja
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Parallel group, 2-arm, superiority trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of the study | 18 months | Time taken to recruit the required subjects (n=50) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Outcomes | 6 months | Death and hospitalisation rates |
| Clinical outcomes | 6 months | Changes in office BP |
Countries
Nigeria
Outcome results
None listed