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01.12.2006 | Study protocol | Ausgabe 1/2006 Open Access

Trials 1/2006

CHARITY: Cha gas car diomyopathy bi soprolol int ervention study: a randomized double-blind placebo force-titration controlled study with Bisoprolol in patients with chronic heart failure secondary to Chagas cardiomyopathy [NCT00323973]

Zeitschrift:
Trials > Ausgabe 1/2006
Autoren:
Franklin R Quiros, Carlos A Morillo, Juan P Casas, Luz A Cubillos, Federico A Silva
Wichtige Hinweise

Competing interests

The author(s) declare that they have no competing interests.

Authors' contributions

CAM, LAC, and JPC, conceived and designed the study, and will be responsible for the overall administration and direction of the project. FRQ has made significant contributions in the recruitment and follow-up of patients. The analysis and interpretation of data and will be performed by all authors and give the final approval of the version to be published. FAS, contributed to the conception and design of the study, performed sample size calculations and randomization and will analyze the data obtained from the clinical trial. All authors read and approved the final manuscript.

Abstract

Background

Chagas' disease is the major cause of disability secondary to tropical diseases in young adults from Latin America, and around 20 million people are currently infected by T. cruzi. Heart failure due to Chagas cardiomyopathy is the main clinical presenation in Colombia. Heart failure due to Chagas' disease may respond to digoxin, diuretics and vasodilator therapy. Beta-adrenoreceptor antagonism seems to protect against the increased risk of cardiac arrhythmia and sudden death due to chronic sympathetic stimulation. The aim of this study is to evaluate 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 heart failure secondary to Chagas' cardiomyopathy.

Methods/design

A cohort of 500 T. cruzi seropositive patients (250 per arm) will be selected from several institutions in Colombia. During the pretreatment period an initial evaluation visit will be scheduled in which participants will sign consent forms and baseline measurements and tests will be conducted including blood pressure measurements, twelve-lead ECG and left ventricular ejection fraction assessment by 2D echocardiography. Quality of life questionnaire will be performed two weeks apart during baseline examination using the "Minnesota living with heart failure" questionnaire. A minimum of two 6 minutes corridor walk test once a week over a two-week period will be performed to measure functional class. During the treatment period patients will be randomly assigned to receive Bisoprolol or placebo, initially taking a total daily dose of 2.5 mgrs qd. The dose will be increased every two weeks to 5, 7.5 and 10 mgrs qd (maximum maintenance dose). Follow-up assessment will include clinical check-up, and blood collection for future measurements of inflammatory reactants and markers. Quality of life measurements will be obtained at six months. This study will allow us to explore the effect of beta-blockers in chagas' cardiomyopathy.
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