Status:
COMPLETED
Chagas Cardiomyopathy Bisoprolol Intervention Study: Charity
Lead Sponsor:
Fundación Cardiovascular de Colombia
Conditions:
Chagas Cardiomyopathy
Chronic Heart Failure
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
Chagas disease (CD) is the major cause of disability secondary to tropical diseases in young adults from Latin America. In this region 20 million people are currently infected by T. cruzi, the etiolog...
Detailed Description
BACKGROUND Chagas disease (CD) is a permanent threat for almost a quarter of the population of Latin America. Although the disease has been described in almost all Central and South America, clinical...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2006
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT00323973
Start Date
July 1 2003
End Date
July 1 2006
Last Update
November 24 2010
Active Locations (1)
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1
Fundación Cardiovascular de Colombia
Floridablanca, Santander Department, Colombia, 10000