The Evidence-based Treatment of Hypertensive Heart Failure in Sub-Saharan Africa: A Feasibility Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Feasibility of the study
研究概览
简要总结
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.
详细描述
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:
- 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.
- To determine the effect of ISDN-HYD on the following:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Conventional HF medications plus ISDN & HYD
Will administer Isosorbide dinitrate (5mg bd) and Hydralazine (25mg bd) on top of conventional heart failure medications.
干预措施: Isosorbide Dinitrate (Drug)
Conventional HF medications plus placebo
We will administer placebo on top of conventional heart failure medications
干预措施: Isosorbide Dinitrate (Drug)
结局指标
主要结局
Feasibility of the study
时间窗: 18 months
Time taken to recruit the required subjects (n=50)
次要结局
- Clinical Outcomes(6 months)
- Clinical outcomes(6 months)
研究者
Dr. Dike Ojji
Associate Professor
University of Abuja