Bi Treatment With Hydralazine/Nitrates Versus Placebo in Africans Admitted With Acute Heart Failure (B-AHEF)
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|ClinicalTrials.gov Identifier: NCT01822808|
Recruitment Status : Unknown
Verified August 2015 by Prof. Karen Sliwa, University of Cape Town.
Recruitment status was: Active, not recruiting
First Posted : April 2, 2013
Last Update Posted : August 14, 2015
To investigate the effect of hydralazine isosorbide dinitrate on clinical outcomes, symptoms, cardiac parameters and functional status of African patients hospitalized with AHF and left ventricular dysfunction during 24 weeks of therapy.
Administration of hydralazine/nitrates will be superior to placebo administration in reducing HF readmission or death, improving dyspnoea, reducing blood pressure and brain natriuretic peptide (BNP) in African patients admitted with AHF and left ventricular dysfunction.
|Condition or disease||Intervention/treatment||Phase|
|Acute Heart Failure Left Ventricular Dysfunction||Drug: Hydralazine Drug: Isosorbide Dinitrate||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Prospective, Placebo-controlled, Double-blind, Randomized Study to Compare Hydralazine-isosorbide-dinitrate(HYIS) Versus Placebo on Top of Std Care in African Patients With Acute Heart Failure (AHF) and Left Ventricular Dysfunction|
|Study Start Date :||January 2013|
|Estimated Primary Completion Date :||January 2016|
|Estimated Study Completion Date :||July 2016|
Active Comparator: Hydralazine
24 week course of Hydralazine 25mg 3 times daily for 4 weeks, thereafter uptitrating to 50mg hydralazine 3 times daily up to week 24. Those assigned to the Hydralazine control arm will receive the same number of identical placebo tablets.
Hydralazine and placebo will be supplied as 25mg identical tablets and given at a dosage of 75mg/day up to week 4, thereafter 150mg/day up to week 24.
Other Name: Hyperphen
Active Comparator: Isosorbide dinitrate
24 week course of Isosorbide dinitrate 10mg 3 times daily for 4 weeks, thereafter uptitrating to 20mg isosorbide dinitrate 3 times daily up to week 24. Those assigned to the Isosorbide dinitrate control arm will receive the same number of identical placebo tablets.
Drug: Isosorbide Dinitrate
Isosorbide dinitrate and placebo will be supplied as 10mg identical tablets and given at a dosage of 30mg/day up to week 4, thereafter 60mg/day up to week 24.
Other Name: Isordil
- Time to death or HF re-admission [ Time Frame: through to day 180 ]In African patients admitted with acute heart failure, to investigate the effect of the combination of hydralazine/isosorbide dinitrate (HYIS) on the rate of death or re-admission for HF during 24 weeks of therapy
- Change in symptoms of heart failure [ Time Frame: within 7 days post randomization ]Change in symptoms of HF from baseline to 7 days post randomization or discharge, as assessed by dyspnoea severity and global well being on a VAS scale
- Change in systolic blood pressure [ Time Frame: within 7 days post randomization ]Change in systolic blood pressure from baseline to 7 days post randomization or discharge and at 8 weeks and 24 weeks post randomization
- Functional status [ Time Frame: 7 days post randomization ]Functional status assessed by 6 minute walk at 7 days post randomization or discharge, and at 8 weeks and 24 weeks post randomization
- Changes in serum creatinine [ Time Frame: up to 8 weeks post randomization ]Changes in serum creatinine, blood urea nitrogen (BUN) and estimated glomerular filtration rate (eGFR) from baseline to 8 weeks post randomization and at 24 weeks post randomization
- Change in left ventricular dimensions [ Time Frame: up to 24 weeks post randomization ]Change in left ventricular dimensions and left ventricular ejection fraction (LVEF) from baseline to 24 weeks post randomization.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01822808
|Hatter Institute for Cardiovascular Research in Africa|
|Cape Town, Western Cape, South Africa, 7925|
|Principal Investigator:||Karen Sliwa, PhD||Hatter Institute for Cardiovascular Research In Africa (HICRA), University of Cape Town|
|Study Director:||Gad Cotter, MD||Momentum Research, Inc.|