Chagas DiseaseCH0660/10NCT02295215
Exercise Training in Patients With Chagasic Heart Disease Without Ventricular Dysfunction
A study testing Exercise in people with Chagas Disease, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Chagas Disease
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Chagas' disease patients, diagnosed with at least two positive serological reactions to Chagas' disease,
- Ejection fraction ≥55%
Who cannot join
- 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
Show all 11Show fewer
- Hypertension
- Pulmonary Disease
- Valvular lesions
- Atrial Fibrillation
- Angina of effort
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Heart Institute - HC-FMUSP
São Paulo, São Paulo, 05403-900
Adriana S Oliveira, 5511 26615057, adriana.sarmento@usp.br
About this study
Official title: Effects of Physical Training on Sensitivity Baroreflex Patients Without Chagas' Heart Ventricular Systolic Dysfunction
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.
Read the detailed description
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
- Chagas Disease
- Being tested
- Exercise
- Keywords
- chagas disease, exercise, baroreflex sensitivity
- Medical subject headings
- Chagas Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Exercise Training for 4 months
| Study group | Role | What they receive |
|---|---|---|
| Sedentary Group | No intervention | The patients will not do exercise training |
| Trained Group | Experimental | The patients will do exercise training for sixteen weeks. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sympathetic nerve activityAutonomic control
Exercise training will improve baroreflex sensitivity and reduce sympathetic nerve activity.
Measured: 4 months
Secondary outcomes (2)
Peak oxygen consumption
Exercise training will improve peak oxygen consumption
Measured: 4 months
Skeletal muscle strength
Exercise training will increase skeletal muscle strength
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2014 (estimated)
- Study startJun 2013
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chagas DiseaseStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adriana O Sarmento, Principal investigator, University of Sao Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02295215
- Sponsor's protocol ID
- NCT01900000
- Acronym
- CH0660/10
- Status last verified
- Jun 2013
- First submitted
- 25 Aug 2014
- Last updated
- 20 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 32875456
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Physical Training on Sensitivity Baroreflex Patients Without Chagas' Heart Ventricular Systolic Dysfunction
- ClinicalTrials.gov ID
- NCT02295215
- Acronym / sponsor ID
- CH0660/10 / NCT01900000
- Conditions
- Chagas Disease
- Keywords
- chagas disease, exercise, baroreflex sensitivity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 20 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sedentary Group | No intervention | –The patients will not do exercise training |
| Trained Group | Experimental | Other: ExerciseThe patients will do exercise training for sixteen weeks. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Chagas' disease patients, diagnosed with at least two positive serological reactions to Chagas' disease,
- Ejection fraction ≥55%
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseExercise Training for 4 months | Other | Trained Group |
Primary outcome
Sympathetic nerve activityAutonomic control
Time frame: 4 months
Exercise training will improve baroreflex sensitivity and reduce sympathetic nerve activity.
2 secondary outcomes
Peak oxygen consumption
Time frame: 4 months
Skeletal muscle strength
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2014.
- Derived from this study: PubMed 32875456Sarmento 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adriana O Sarmento principal investigator
University of Sao Paulo General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Chagas Disease, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carlos E Negrão (5511 26615699, cndnegrao@incor.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sympathetic nerve activityAutonomic control (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02295215, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2014.