Clinical Trial: Chagas Cardiomyopathy Bisoprolol Intervention Study: Charity

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized Double-blind Placebo Force-titration Controlled Study With Bisoprolol in Patients With Chronic Heart Failure Secondary to Chagas´ Cardiomyopathy.

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 etiologic agent for CD. In Colombia, 18 percent of the population live in CD endemic areas, 900,000 people are infected and over three million are at high risk of being infected. Heart failure due to Chagas cardiomyopathy (CCM) is the main clinical form of CD in Colombia. However, the incidence of CCM among T. cruzi infected people is unknown and the mechanisms that lead from infection to CCM are uncertain. Besides the poor prognosis of CHF due to Chagas disease, it is important to estimate the risk of complications and death in patient infected with T. cruzi Unfortunately, few clinical studies have addressed this issue. Most T. cruzi infected patients have mild or no clinical disease, however, the percentage of infected people that will develop detectable cardiac abnormalities is approximately 30 to 40 percent, but only 20 percent of them will develop symptomatic cardiac involvement. Like CHF from other causes, CHF due to CD responds to digital, diuretics and vasodilators therapy. Also, some studies have shown that angiotensin-converting enzyme (ACE) inhibitors improve survival in patients with moderate to severe CHF due to CD. Increased sympathetic drive results in an increased risk of cardiac arrhythmia and sudden death. Beta-adrenoreceptor antagonism seems to protect against the deleterious effects of chronic sympathetic stimulation. The effects of the selective beta-adrenergic receptor blocker Bisoprolol on cardiovascular mortality, hospital readmission due to progressive heart failure and functional status in patients with CHF secondary to CCM has not been explored to-date. To evaluate the benefit of Bisoprolol in CHF due to CCM, a cohort of T. cruzi seropositive patients will be selected from several institutions in Colombia. Patients will be classified according to a m

Detailed Summary:

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 presentation and epidemiological characteristics are highly variable among the different endemic zones (1,2). A wide range of prevalence rates has also been reported suggesting local differences in transmission of the disease as well as differences in vectors and reservoirs (3). Chagas cardiomyopathy (CCM) represents a serious public health problem in most Latin American countries, and the most recent statistics provided by the World Health Organization indicate that 100 million persons are exposed to the disease and approximately 20 million are currently infected (4). Interestingly, in addition to the natural infection foci, an increase in the transmission associated with blood transfusions has also been noticed. These statistics are considered an underestimation of the real rates of infection, most likely due to lack of reports from highly endemic retired rural communities. In countries in which the disease is endemic such as Colombia, Venezuela and Brazil, the overall prevalence of infection averages 10 percent. However, in highly endemic rural areas rates have ranged from 25 to 75 percent (5). Prevalence of infection varies widely even between cities and provinces within the same country because of variations in climate, housing condition, public health measures, and urbanization. The actual prevalence of clinical Chagas disease and the number of case fatalities are largely unknown, mainly because case reporting is virtually nonexistent in many areas in which CD is highly endemic. Congestive heart failure (CHF) is a late manifestation of CD that results from structural abnormalities and extensive and irreversible damage to the myocardium. Heart failure in T. cruzi infecte
Sponsor: Fundación Cardiovascular de Colombia

Current Primary Outcome:

  • Hospital admission caused by heart failure. [ Time Frame: 2 years ]
  • Major adverse cardiovascular events: stroke, systemic embolism, resuscitated sudden death. [ Time Frame: 2 years ]
  • Bradycardia requiring pacemaker implantation. [ Time Frame: 2 years ]
  • Clinically significant sustained monomorphic ventricular tachycardia causing syncope: sustained ventricular tachycardia or ventricular fibrillation. [ Time Frame: 2 years ]


Original Primary Outcome:

  • Cardiovascular death.
  • Hospital admission caused by heart failure.
  • Major adverse cardiovascular events: stroke, systemic embolism, resuscitated sudden death.
  • Bradycardia requiring pacemaker implantation.
  • Clinically significant sustained monomorphic ventricular tachycardia causing syncope: sustained ventricular tachycardia or ventricular fibrillation.


Current Secondary Outcome:

  • Non-cardiovascular death. [ Time Frame: 2 years ]
  • Heart failure worsening or mortality related with CHF. [ Time Frame: 2 years ]
  • New AV block. [ Time Frame: 2 years ]
  • Need for Implantable cardioverter-defibrillator (ICD), Cardiac resynchronization Therapy (CRT) or Pacemaker therapy (PM). [ Time Frame: 2 years ]
  • Perceived quality of life worsening. [ Time Frame: 2 years ]


Original Secondary Outcome:

  • Non-cardiovascular death.
  • Heart failure worsening or mortality related with CHF.
  • New AV block.
  • Need for Implantable cardioverter-defibrillator (ICD), Cardiac resynchronization Therapy (CRT) or Pacemaker therapy (PM).
  • Perceived quality of life worsening.


Information By: Fundación Cardiovascular de Colombia

Dates:
Date Received: May 5, 2006
Date Started: July 2003
Date Completion:
Last Updated: November 23, 2010
Last Verified: November 2010