Chagas DiseasePhase 2/3NCT02516293
Cardiac Rehabilitation in Chagas Heart Failure
A Phase 2/3 study testing Exercise, nutritional and pharmaceutical counseling in people with Chagas Disease and Chagas Cardiomyopathy, run by Evandro Chagas National Institute of Infectious Disease at 1 site in Brazil.
Trial summary
Due to the lack of information in the literature about the role of cardiac rehabilitation on Chagas heart failure, the aim of the present study was to evaluate the effects of a cardiac exercise program on functional capacity, cardiac function, respiratory muscle strength, body composition, biomarkers and quality of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chagas Disease, Chagas Cardiomyopathy
- What is being tested?
- Exercise, nutritional and pharmaceutical counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteBrazil
- Study dates
- May 2013to Dec 2014
- Phase
- Phase 2/3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients at the stages C or D of Chagas cardiomyopathy
- Patients receiving standard optimized medical therapy
- Patients with good adherence to outpatient treatment within the last three months.
Who cannot join
- Those who were not able to attend three weekly training sessions,
- Those who had neuromuscular limitations, cardiopathies from non-Chagasic etiology (e.g ischemic), systemic conditions that limits exercise practice (e.g chronic obstructive pulmonary disease)
- Practitioners of regular exercise.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Evandro Chagas National Institute of Infectious Disease
Rio de Janeiro, Rio de Janeiro, 21040-360
About this study
Official title: Cardiac Rehabilitation Program in Patients With Chagas Heart Failure: a Pilot Study
Due to the lack of information in the literature about the role of cardiac rehabilitation on Chagas heart failure, the aim of the present study was to evaluate the effects of a cardiac exercise program on functional capacity, cardiac function, respiratory muscle strength, body composition, biomarkers and quality of life among Chagas heart failure patients.
Read the detailed description
The present study consisted in a pre/post single-arm intervention study conducted at the Evandro Chagas National Institute of Infectious Disease (INI), located on Rio de Janeiro, Brazil. INI is a national reference center for treatment and research in infectious diseases and tropical medicine in Brazil, which follows a large cohort of patients with Chagas disease, all of them diagnosed by two simultaneously positive serological tests (enzyme-linked immunosorbent assay and indirect immunofluorescence). Patients included in the study were submitted to a physical exercise intervention protocol performed three times per week, 60 minutes per session, during an 8-month period. Nutritional and pharmaceutical counseling were also monthly provided during the follow-up and consisted on general guidance about adequate eating habits for patients with heart failure, mainly sodium and water intake, and medication usage, particularly drug dosage and compliance.Patients included in the study were followed during an 8-month period in which evaluations of functional capacity (maximal progressive cardiopulmonary exercise test), muscle respiratory strength (manovacuometry) and body composition (anthropometry and skinfolds) were performed at baseline, after four months and at the end of follow-up. Assessments of cardiac function (bidimensional echocardiography), biomarkers (lipid profile, glucose and glycated hemoglobin) and quality of life (Minnesota Living with Heart Failure questionnaire) were taken at baseline and after eight months of follow-up.
- Conditions
- Chagas Disease, Chagas Cardiomyopathy
- Being tested
- Exercise, nutritional and pharmaceutical counseling
- Medical subject headings
- Chagas Disease, Chagas Cardiomyopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise, nutritional and pharmaceutical counselingBehavioural
Physical exercise intervention protocol was performed three times per week, 60 minutes per session, during 8 months. Exercise sessions consisted of 30 minutes of aerobic exercise on a treadmill or on a cycle ergometer, 20 minutes of strength exercises for the major muscle groups (sit-ups, push-ups, and pull-ups), and 10 minutes of stretching exercises. Nutritional and pharmaceutical consisted on general guidance about adequate eating habits for patients with heart failure, mainly sodium and water intake, and medication usage, particularly drug dosage and compliance.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | * Physical exercise intervention
* Nutritional counseling
* Pharmaceutical counseling Receives: Behavioral: Exercise, nutritional and pharmaceutical counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Capacity (VO2 max)
VO2 max (ml/kg/min)
Measured: Change from baseline at 4 and 8 months
Secondary outcomes (8)
Muscle respiratory strength (maximal inspiratory pressure and maximal expiratory pressure)
Maximal inspiratory pressure and maximal expiratory pressure (cm H2O)
Measured: Change from baseline at 4 and 8 months
Body composition (body fat percentage)
Body fat percentage (%)
Measured: Change from baseline at 4 and 8 months
Cardiac function (mainly ejection fraction)
Ejection fraction (%)
Measured: Change from baseline at 8 months
Biomarkers (lipid profile and glucose)
Total cholesterol, Triacylglycerol, HDL-cholesterol, LDL-cholesterol, VLDL-cholesterol (mg/dl) and glucose (mg/dl)
Measured: Change from baseline at 8 months
Biomarkers (glycated hemoglobin)
Glycated hemoglobin (%)
Measured: Change from baseline at 8 months
Quality of life by Minnesota Living with heart failure questionnaire (MLHFQ)
MLHFQ Score ranging from 0 to 105
Measured: Change from baseline at 8 months
Anthropometry
Body weight (kg)
Measured: Change from baseline at 4 and 8 months
Anthropometry
Waist and hip circumference (cm)
Measured: Change from baseline at 4 and 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2015 (estimated)
- Study startMay 2013
- Primary completionJan 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chagas DiseaseStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evandro Chagas National Institute of Infectious Disease
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mauro Felippe Felix Mediano, Evandro Chagas National Institute of Infectious Disease
- Investigators
- Andrea S Sousa, PhD, Principal investigator, Evandro Chagas National Institute of Infectious Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02516293
- Sponsor's protocol ID
- CAAE 0055.0.009.000-11
- Status last verified
- Aug 2015
- First submitted
- 31 Jul 2015
- Last updated
- 5 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Rehabilitation Program in Patients With Chagas Heart Failure: a Pilot Study
- ClinicalTrials.gov ID
- NCT02516293
- Acronym / sponsor ID
- CAAE 0055.0.009.000-11
- Conditions
- Chagas Disease, Chagas Cardiomyopathy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Evandro Chagas National Institute of Infectious DiseaseUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 5 Aug 2015 (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.
Due to the lack of information in the literature about the role of cardiac rehabilitation on Chagas heart failure, the aim of the present study was to evaluate the effects of a cardiac exercise program on functional capacity, cardiac function, respiratory muscle strength, body composition, biomarkers and quality of life among Chagas heart failure patients.
Detailed description
The present study consisted in a pre/post single-arm intervention study conducted at the Evandro Chagas National Institute of Infectious Disease (INI), located on Rio de Janeiro, Brazil. INI is a national reference center for treatment and research in infectious diseases and tropical medicine in Brazil, which follows a large cohort of patients with Chagas disease, all of them diagnosed by two simultaneously positive serological tests (enzyme-linked immunosorbent assay and indirect immunofluorescence). Patients included in the study were submitted to a physical exercise intervention protocol performed three times per week, 60 minutes per session, during an 8-month period. Nutritional and pharmaceutical counseling were also monthly provided during the follow-up and consisted on general guidance about adequate eating habits for patients with heart failure, mainly sodium and water intake, and medication usage, particularly drug dosage and compliance.Patients included in the study were followed during an 8-month period in which evaluations of functional capacity (maximal progressive cardiopulmonary exercise test), muscle respiratory strength (manovacuometry) and body composition (anthropometry and skinfolds) were performed at baseline, after four months and at the end of follow-up. Assessments of cardiac function (bidimensional echocardiography), biomarkers (lipid profile, glucose and glycated hemoglobin) and quality of life (Minnesota Living with Heart Failure questionnaire) were taken at baseline and after eight months of follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Exercise, nutritional and pharmaceutical counseling* Physical exercise intervention * Nutritional counseling * Pharmaceutical counseling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients at the stages C or D of Chagas cardiomyopathy
- Patients receiving standard optimized medical therapy
- Patients with good adherence to outpatient treatment within the last three months.
Key exclusion criteria (3 listed)
- Those who were not able to attend three weekly training sessions,
- Those who had neuromuscular limitations, cardiopathies from non-Chagasic etiology (e.g ischemic), systemic conditions that limits exercise practice (e.g chronic obstructive pulmonary disease)
- Practitioners of regular exercise.
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 |
|---|---|---|
| Exercise, nutritional and pharmaceutical counselingPhysical exercise intervention protocol was performed three times per week, 60 minutes per session, during 8 months. Exercise sessions consisted of 30 minutes of aerobic exercise on a treadmill or on a cycle ergometer, 20 minutes of strength exercises for the major muscle groups (sit-ups, push-ups, and pull-ups), and 10 minutes of stretching exercises. Nutritional and pharmaceutical consisted on general guidance about adequate eating habits for patients with heart failure, mainly sodium and water intake, and medication usage, particularly drug dosage and compliance. | Behavioural | Intervention group |
Primary outcome
Functional Capacity (VO2 max)
Time frame: Change from baseline at 4 and 8 months
VO2 max (ml/kg/min)
8 secondary outcomes
Muscle respiratory strength (maximal inspiratory pressure and maximal expiratory pressure)
Time frame: Change from baseline at 4 and 8 months
Body composition (body fat percentage)
Time frame: Change from baseline at 4 and 8 months
Cardiac function (mainly ejection fraction)
Time frame: Change from baseline at 8 months
Biomarkers (lipid profile and glucose)
Time frame: Change from baseline at 8 months
Biomarkers (glycated hemoglobin)
Time frame: Change from baseline at 8 months
Quality of life by Minnesota Living with heart failure questionnaire (MLHFQ)
Time frame: Change from baseline at 8 months
Anthropometry
Time frame: Change from baseline at 4 and 8 months
Anthropometry
Time frame: Change from baseline at 4 and 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2015.
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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.
Andrea S Sousa, PhD principal investigator
Evandro Chagas National Institute of Infectious Disease
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Exercise, nutritional and pharmaceutical counseling in people with Chagas Disease and Chagas Cardiomyopathy, run by Evandro Chagas National Institute of Infectious Disease 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 5 Aug 2015. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Capacity (VO2 max) (time frame: Change from baseline at 4 and 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Aug 2015.