NCT02295215

Brief Summary

The prevalence of Chagas' disease continues high even in the developed countries. Chagasic Cardiomyopathy with preserved ventricular function is an understudied form of Chagas disease. Since a majority of patients with these changes progress to dilated form with ventricular dysfunction with all its serious consequences, it is interesting to better understand the pathophysiology of the disease at the stage where there electrocardiographic changes and preserved ventricular function. And besides, search strategies to slow the progress, or even prevent the chronic phase of the disease. For this reason the investigators will evaluate the effects of exercise training in patients with Chagas cardiomyopathy without ventricular dysfunction.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 20, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

November 20, 2014

Status Verified

June 1, 2013

Enrollment Period

2.5 years

First QC Date

August 25, 2014

Last Update Submit

November 14, 2014

Conditions

Chagas Disease

Keywords

chagas diseaseexercisebaroreflex sensitivity

Outcome Measures

Primary Outcomes (1)

  • Sympathetic nerve activityAutonomic control

    Exercise training will improve baroreflex sensitivity and reduce sympathetic nerve activity.

    4 months

Secondary Outcomes (2)

  • Peak oxygen consumption

    4 months

  • Skeletal muscle strength

    4 months

Study Arms (2)

Sedentary Group

NO INTERVENTION

The patients will not do exercise training

Trained Group

EXPERIMENTAL

The patients will do exercise training for sixteen weeks.

Other: Exercise

Interventions

ExerciseOTHER

Exercise Training for 4 months

Trained Group

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Chagas' disease patients, diagnosed with at least two positive serological reactions to Chagas' disease,
  • Ejection fraction ≥55%

You may not qualify if:

  • Participation in a regular exercise program in the last 3 months preceding the survey
  • Use of oral anticoagulant
  • Use of a pacemaker or implantable cardioverter
  • Hemodynamic instability
  • Myocardial revascularization infarction or unstable angina in the last 3 months of the start of the protocol
  • Diabetes mellitus
  • Hypertension
  • Pulmonary Disease
  • Valvular lesions
  • Atrial Fibrillation
  • Angina of effort

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heart Institute - HC-FMUSP

São Paulo, São Paulo, 05403-900, Brazil

RECRUITING

Related Publications (1)

  • Sarmento AO, Antunes-Correa LM, Alves MJNN, Bacurau AVN, Fonseca KCB, Pessoa FG, Lobo DML, Moreira LDP, Trombetta IC, Rondon MUPB, Rondon E, Vieira MLC, Ramires FJA, do Brasileiro-Santos MS, Brum PC, Mady C, Negrao CE, Thomas S, Ianni BM. Effect of exercise training on cardiovascular autonomic and muscular function in subclinical Chagas cardiomyopathy: a randomized controlled trial. Clin Auton Res. 2021 Apr;31(2):239-251. doi: 10.1007/s10286-020-00721-1. Epub 2020 Sep 1.

    PMID: 32875456DERIVED

MeSH Terms

Conditions

Chagas DiseaseMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

TrypanosomiasisEuglenozoa InfectionsProtozoan InfectionsParasitic DiseasesInfectionsVector Borne DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Adriana O Sarmento

    University of Sao Paulo General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Carlos E Negrão

CONTACT

5511 26615699cndnegrao@incor.usp.br

Adriana S Oliveira

CONTACT

5511 26615057adriana.sarmento@usp.br

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2014

First Posted

November 20, 2014

Study Start

June 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

November 20, 2014

Record last verified: 2013-06

Locations

BR(1)