Status:
UNKNOWN
Bi Treatment With Hydralazine/Nitrates Versus Placebo in Africans Admitted With Acute Heart Failure
Lead Sponsor:
University of Cape Town
Collaborating Sponsors:
Momentum Research, Inc.
Conditions:
Acute Heart Failure
Left Ventricular Dysfunction
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 dy...
Detailed Description
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 hospital...
Eligibility Criteria
Inclusion
- \> 18 years of age
- 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.
- 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
- 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)
- Available for regular follow up
Exclusion
- Currently being treated with Hydralazine and/or nitrates or a history of intolerance to oral therapy with either hydralazine or nitrates.
- . Any intravenous treatment for heart failure, except IV furosemide (eg. IV inotropes, pressors, nitrates or nesiritide) at the time of screening.
- Systolic blood pressure \<100 mmHg
- Plan for revascularization
- Greater than 96 hours after admission
- 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.
- Hypertrophic obstructive cardiomyopathy, constrictive cardiomyopathy, endomyocardial fibroelastosis
- Known severe congenital heart disease (such as uncorrected tetralogy of fallot or transposition of the aorta)
- Severe aortic or mitral stenosis or severe rheumatic mitral regurgitation.
- Renal impairment (defined by creatinine \>3 mg/dL) at screening or on any type of dialysis.
- Known hepatic impairment (total bilirubin \>3mg/dl) or increased ammonia levels at screening.
- History of systemic lupus erythematous.
- Stroke or TIA within 2 weeks from screening.
- Women who are pregnant or lactating.
- Allergy to organic nitrates.
- History or presence of any other diseases (ie. Including malignancies or AIDS) with a life expectancy of \< 12 months
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2016
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT01822808
Start Date
January 1 2013
End Date
July 1 2016
Last Update
August 14 2015
Active Locations (1)
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1
Hatter Institute for Cardiovascular Research in Africa
Cape Town, Western Cape, South Africa, 7925