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

Launched by UNIVERSITY OF CAPE TOWN · Apr 1, 2013

Keywords

ClinConnect Summary

Heart failure (HF) is a pathophysiologic condition and is a final common pathway of most forms of cardiovascular disease. Patients with HF experience poor quality of life, recurrent emergency hospitalizations and premature mortality.

Recent publications highlight the multiple challenges of dealing with an increasing burden of heart disease within an urban African community. The predominance of women and novel underlying causes contrast with the demographic of HF in high income countries. More than 50% of 5328 de novo cases of heart disease captured at a tertiary clinic in Soweto presented ...

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Eligibility 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