title: Bi treatment with hydralazine/nitrates vs. placebo in Africans admitted with acute HEart Failure (BA-HEF).
abstract: OBJECTIVE
  Patients with acute heart failure (HF) in Africa are rarely being treated with a hydralazine/nitrates combination. Therefore the effect of this treatment was studied here.
  
  
  RESULTS
  The study was planned to enrol 500 patients during an acute HF admission, from nine sub-Saharan 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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  NCT01822808.
authors.affiliation: 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.
authors.forename: Karen
authors.initials: K
authors.lastname: Sliwa
authors.affiliation: Faculty of Medicine, Eduardo Mondlane University, Maputo, Mozambique.
authors.forename: Albertino
authors.initials: A
authors.lastname: Damasceno
authors.affiliation: Momentum Research, Inc., Durham, NC, USA.
authors.forename: Beth A
authors.initials: BA
authors.lastname: Davison
authors.affiliation: Department of Medicine, Groote Schuur Hospital and University of Cape Town, Cape Town, South Africa.
authors.forename: Bongani M
authors.initials: BM
authors.lastname: Mayosi
authors.affiliation: Department of Medicine, Bayero University Kano/Aminu Kano Teaching Hospital, Kano, Nigeria.
authors.forename: Mahmoud U
authors.initials: MU
authors.lastname: Sani
authors.affiliation: University College Hospital, Ibadan, Nigeria.
authors.forename: Okekuchwu
authors.initials: O
authors.lastname: Ogah
authors.affiliation: Department of Medicine, Mulago Hospital, Kampala, Uganda.
authors.forename: Charles
authors.initials: C
authors.lastname: Mondo
authors.affiliation: Cardiology Unit, Department of Medicine, University of Abuja Teaching Hospital, Abuja, Nigeria.
authors.forename: Dike
authors.initials: D
authors.lastname: Ojji
authors.affiliation: Department of Internal Medicine, Douala General Hospital and Buea Faculty of Health Sciences, Douala, Cameroon.
authors.forename: Anastase
authors.initials: A
authors.lastname: Dzudie
authors.affiliation: Yaoundé General Hospital and Dschang University, Cameroon.
authors.forename: Charles Kouam
authors.initials: CK
authors.lastname: Kouam
authors.affiliation: Deparment of Medicine, Aga Khan University Hospital, Kenya.
authors.forename: Gerald
authors.initials: G
authors.lastname: Yonga
authors.affiliation: Service de Cardiologie, Université Cheikh Anta DIOP, Dakar, Senegal.
authors.forename: Serigne Abdou
authors.initials: SA
authors.lastname: Ba
authors.affiliation: Department of Clinical Medicine and Therapeutics, College of Health Sciences University of Nairobi, Kenyatta National Hospital, Nairobi, Kenya.
authors.forename: Elijah
authors.initials: E
authors.lastname: Ogola
authors.affiliation: Momentum Research, Inc., Durham, NC, USA.
authors.forename: Christopher
authors.initials: C
authors.lastname: Edwards
authors.affiliation: Momentum Research, Inc., Durham, NC, USA.
authors.forename: Olga
authors.initials: O
authors.lastname: Milo
authors.affiliation: Momentum Research, Inc., Durham, NC, USA. gadcotter@momentum-research.com.
authors.forename: Gad
authors.initials: G
authors.lastname: Cotter
mesh_terms: D000208:Acute Disease; D000328:Adult; D017954:Africa South of the Sahara; D000368:Aged; D044383:Black People; D004311:Double-Blind Method; D006333:Heart Failure / Q000188:drug therapy* / Q000208:ethnology; D006801:Humans; D006830:Hydralazine / Q000008:administration & dosage*; D007548:Isosorbide Dinitrate / Q000008:administration & dosage*; D008875:Middle Aged; D011446:Prospective Studies; D014665:Vasodilator Agents / Q000008:administration & dosage*
chemical_list: D014665:Vasodilator Agents; D006830:Hydralazine; D007548:Isosorbide Dinitrate
keywords: Acute heart failure; Africa; Hydralazine; Nitrates; Treatment