MedDataX Logo

Exercise Training in Patients With Chagasic Heart Disease Without Ventricular Dysfunction

NCT ID: NCT02295215

Last Updated: 2014-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2015-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chagas Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sedentary Group

The patients will not do exercise training

Group Type NO_INTERVENTION

No interventions assigned to this group

Trained Group

The patients will do exercise training for sixteen weeks.

Group Type EXPERIMENTAL

Exercise

Intervention Type OTHER

Exercise Training for 4 months

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Exercise

Exercise Training for 4 months

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

25 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Adriana O Sarmento

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo General Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Heart Institute - HC-FMUSP

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Brazil

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Carlos E Negrão

Role: CONTACT

[email protected]
5511 26615699

Adriana S Oliveira

Role: CONTACT

[email protected]
5511 26615057

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Adriana S Oliveira

Role: primary

[email protected]
5511 26615057

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 32875456 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NCT01900000

Identifier Type: -

Identifier Source: org_study_id