Bi treatment with hydralazine/nitrates vs. placebo in Africans admitted with acute heart failure (BA-HEF) - Research summary

Aug 23, 2026

Bi treatment with hydralazine/isosorbide dinitrate (HYIS) was evaluated against placebo in Africans admitted with acute heart failure (BA-HEF), addressing limited use of this therapy in sub-Saharan settings. In a double-blind randomized design across nine countries, patients received HYIS for 24 weeks followed by open-label HYIS, then outcomes were assessed through 24 weeks. Recruitment challenges curtailed enrollment (147 total). The primary endpoint of death or heart-failure readmission showed neutrality, while secondary measures suggested non-significant trends favoring HYIS.

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CategoryResearch & Report

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European Journal of Heart Failure (2016) doi:10.1002/ejhf.581 Bi treatment with hydralazine/nitrates vs. placebo in Africans admitted with acute HEart Failure (BA-HEF) Karen Sliwa 1, Albertino Damasceno2, Beth A. Davison3, Bongani M. Mayosi4, Mahmoud U. Sani5, Okekuchwu Ogah6, Charles Mondo7, Dike Ojji8, Anastase Dzudie9, Charles Kouam Kouam 10, Gerald Yonga 11, Serigne Abdou Ba 12, Elijah Ogola 13, Christopher Edwards3, and Gad Cotter3,* 1 Hatter Institute for Cardiovascular Research in Africa & IDM, Inter Cape Heart Group South African Medical Research Council, Department of Medicine, Faculty of Health Sciences, University of Cape Town, South Africa; 2 Faculty of Medicine, Eduardo Mondlane University, Maputo, Mozambique; 3 Momentum Research, Inc., Durham, NC, USA; 4 Department of Medicine, Groote Schuur Hospital and University of Cape Town, Cape Town, South Africa; 5 Department of Medicine, Bayero University Kano/Aminu Kano Teaching Hospital, Kano, Nigeria; 6 University College Hospital, Ibadan, Nigeria; 7 Department of Medicine, Mulago Hospital, Kampala, Uganda; 8 Cardiology Unit, Department of Medicine, University of Abuja Teaching Hospital, Abuja, Nigeria; 9 Department of Internal Medicine, Douala General Hospital and Buea Faculty of Health Sciences, Douala, Cameroon; 10Yaoundé General Hospital and Dschang University, Cameroon; 11 Deparment of Medicine, Aga Khan University Hospital, Kenya; 12Service de Cardiologie, Université Cheikh Anta DIOP, Dakar, Senegal; and 13Department of Clinical Medicine and Therapeutics, College of Health Sciences University of Nairobi, Kenyatta National Hospital, Nairobi, Kenya Received 23 April 20 16; revised 4 May 2016; accepted 5 May 20 16 Aims Patients with acute heart failure in Africa are rarely being treated with a hydralazine/nitrates combination. Therefore the effect of this treatment was studied here ............................................................... ................................................................ ...................................... Methods The study was planned to enrol 500 patients during an acute heart failure (HF) admission, from nine sub-Saharan and results African countries. Patients were randomized in a double-blind manner to receive 50 mg hydralazine/20 mg isosorbide dinitrate (HYIS) t.i.d. or matching placebo for 24 weeks followed by open label HYIS for all patients. The study was terminated after 147 patients were enrolled due mostly to issues with recruitment into a prospective, placebo-controlled study. Most patients were recruited from Mozambique, South Africa, Kenya, and Uganda. The primary endpoint of death or HF readmission through 24 weeks was neutral [hazard ratio (HR) 1.05, 95% confidence interval (CI) 0.48–2.27, P = 0.90] in the 133 randomized patients included in the analyses. There were non-signficant effects in favour of HYIS in secondary endpoints including change in dyspnoea severity at day 7 or discharge, decrease in systolic blood pressure, greater decrease in weight, and increase in 6-min walk test distance at week 24. There were also small changes in echocardiographic indices of cardiac size and function in favour or HYIS, but none was significant. ............................................................... ................................................................ ...................................... Conclusion The BA-HEF trial demonstrated challenges in recruiting the expected number of patients with acute HF in a number of African countries, which highlights the need for strategic logistic support. Trial registration: NCT0 1822808. .......................................................................................................... Keywords Treatment • Acute heart failure • Hydralazine • Nitrates • Africa Introduction Acute heart failure (AHF) is one of the most common reasons for admission to hospital and a major driver for health-related costs worldwide. A numb

FAQs

What is the BA-HEF study aiming to test?

The study examines the effect of hydralazine/nitrates (HYIS) in African patients admitted with acute heart failure, compared with placebo, and extends follow-up through 6 months.

How was treatment assigned in the trial?

Patients were randomized in a double-blind manner to receive 50 mg hydralazine/20 mg isosorbide dinitrate three times daily or matching placebo for 24 weeks, followed by open-label HYIS for all participants.

Did HYIS improve the main outcome compared with placebo?

No. The primary endpoint of death or heart-failure readmission through 24 weeks was neutral, with a hazard ratio close to 1 and no statistically significant difference reported.

Aug 23, 2026

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