Chagas Cardiomyopathy Bisoprolol Intervention Study: Charity
Chagas Cardiomyopathy, Chronic Heart Failure
About this trial
This is an interventional treatment trial for Chagas Cardiomyopathy focused on measuring Chagas, Heart failure, Cardiomiopathy
Eligibility Criteria
Inclusion Criteria: Males or females aged 18 to 70 years. Heart failure symptoms NYHA functional class II to IV Left ventricular ejection fraction <40% determined by bi-dimensional echocardiography using modified Simpson's rule for ventricular volumes. Subjects must be on standard and stable outpatient doses of ACEIs or angiotensin II receptor antagonist for at least four weeks. Subjects receiving diuretics must be on a stable dose for at least two weeks. Clinical Euvolemia:as evidenced by absence of rales, no pleural effusion or ascitis and no more than minimal peripheric edema. Exclusion Criteria: CHF due to ischemic heart disease, valvular disease or any other etiology different than CD. Severe aortic insufficiency Baseline advanced AV block defined as Mobitz type 2 or third degree AV block Serum creatinine >2.5 mg/dl. Resting Heart rate less < 45 bpm Known malignancy and other severe disease which shorten life expectancy < 6 months. Subjects with contraindications for beta-blockers: severe obstructive chronic pulmonary disease, asthma, severe pulmonary hypertension, type 1 diabetes mellitus or history of hypoglicemia. Suspected or confirmed chronic infectious disease including HIV and hepatitis B. History of active substance or alcohol abuse within the last year. Clinically significant psychiatric illness which can negatively affect the subject compliance and participation in the trial. Pregnancy or lactation. Organic disease or gastrointestinal surgery which can affect the oral absorption and pharmacodynamics of the medication under study. Enrollment and participation in other active treatment trial within the previous month. Failure to provide written informed consent.
Sites / Locations
- Fundación Cardiovascular de Colombia
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
1
2
Placebo