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OpenTrials
Completed

NCT Number: NCT01006473

Exercise Training in Chagas Cardiomyopathy

The benefits of exercise training in heart failure are well established. Its effects, however, have not been evaluated in Chagas cardiomyopathy (ChC). The investigators hypothesis is that the exercise training may improve functional capacity, quality of life (QoL), and reduce brain natriuretic peptide (BNP) levels in patients with ChC.

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Key information

Conditions

Chagas Disease Cardiomyopathies Cardiomyopathy Cardiovascular Diseases Chagas Cardiomyopathy Euglenozoa Infections Exercise Training Heart Diseases Infections Parasitic Diseases Protozoan Infections Trypanosomiasis Vector Borne Diseases

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Federal University of Minas Gerais

Belo Horizonte, Minas Gerais, 30130-100, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Chronic Chagas dilated cardiomyopathy, defined by the echocardiography finding of a dilated left ventricle with moderate or severe impaired left ventricular systolic function (left ventricular ejection fraction ≤ 45%).
  • To be clinically stable for at least 3 months
  • To have sinus rhythm
  • To be under standard medical therapy use at the time.

Exclusion criteria

  • Inability to attend regular exercise training
  • The presence of a pacemaker, associated cardiac or systemic diseases
  • Practitioners of regular physical activity

Treatment and study plan

Exercise training

Other

Primary outcomes

  1. Functional capacity

    Time frame: 12 weeks

  2. Functional class

    Time frame: 12 weeks

  3. Health related quality of life

    Time frame: 12 weeks

  4. BNP levels

    Time frame: 12 weeks

Secondary outcomes

  1. Complications related to the exercise training

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Federal University of Minas Gerais

Other

Registry information

Official study title

A Randomized Trial of the Effects of Exercise Training in Chagas Cardiomyopathy

Important dates

Study start
2007
Primary completion
2008
Study completion
2009
First posted
Nov 2, 2009
Registry last updated
Aug 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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