Bi Treatment With Hydralazine/Nitrates Versus Placebo in Africans Admitted With Acute Heart Failure

• Status: Unknown status
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Cape Town
• Collaborator: Momentum Research, Inc.
• Treatments: Hydralazine; Isosorbide; Isosorbide Dinitrate; Isosorbide-5-mononitrate

Criteria

Inclusion Criteria:

1. > 18 years of age

2. Hospital admission for acute heart failure as defined by the presence of acute dyspnea and the presence of clinical signs of heart failure on physical examination.

3. Where available, NT-proBNP >900 pg/ml, >1800 pg/ml if the patient has atrial fibrillation at screening or >450 pg/ml if BMI > 35 kg/m2, LVEF <45% assessed by echocardiography or other method within the previous 12 months

4. Background therapy with at least ACE-inhibitor or angiotensin receptor blocker (ARB) and beta-blocker (unless beta-blocker is contraindicated due to severe volume overload, low output heart failure, or cardiogenic shock)

5. Available for regular follow up

Exclusion Criteria:

1. Currently being treated with Hydralazine and/or nitrates or a history of intolerance to oral therapy with either hydralazine or nitrates.

2. . Any intravenous treatment for heart failure, except IV furosemide (eg. IV inotropes, pressors, nitrates or nesiritide) at the time of screening.

3. Systolic blood pressure <100 mmHg

4. Plan for revascularization

5. Greater than 96 hours after admission

6. Reversible etiology of acute heart failure such as myocarditis, acute myocardial infarction, arrhythmia. Acute MI is defined as symptoms and major electrocardiogram (ECG) changes(i.e., ST segment elevations), and arrhythmia includes unstable heart rates above 120/min or below 50/min.

7. Hypertrophic obstructive cardiomyopathy, constrictive cardiomyopathy, endomyocardial fibroelastosis

8. Known severe congenital heart disease (such as uncorrected tetralogy of fallot or transposition of the aorta)

9. Severe aortic or mitral stenosis or severe rheumatic mitral regurgitation.

10. Renal impairment (defined by creatinine >3 mg/dL) at screening or on any type of dialysis.

11. Known hepatic impairment (total bilirubin >3mg/dl) or increased ammonia levels at screening.

12. History of systemic lupus erythematous.

13. Stroke or TIA within 2 weeks from screening.

14. Women who are pregnant or lactating.

15. Allergy to organic nitrates.

16. History or presence of any other diseases (ie. Including malignancies or AIDS) with a life expectancy of < 12 months