Chagas DiseasePhase 4NCT01006473
Exercise Training in Chagas Cardiomyopathy
A Phase 4 study testing Exercise training in people with Chagas Disease and Cardiomyopathy, run by Federal University of Minas Gerais at 1 site in Brazil.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Chagas Disease, Cardiomyopathy, Exercise Training
- What is being tested?
- Exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2007to Mar 2009
- Phase
- Phase 4
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Inability to attend regular exercise training
- The presence of a pacemaker, associated cardiac or systemic diseases
- Practitioners of regular physical activity
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Minas Gerais
Belo Horizonte, Minas Gerais, 30130-100
About this study
Official title: A Randomized Trial of the Effects of 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.
- Conditions
- Chagas Disease, Cardiomyopathy, Exercise Training
- Being tested
- Exercise training
- Keywords
- Chagas Disease, Chagas Cardiomyopathy, Exercise Movement Techniques
- Medical subject headings
- Chagas Disease, Cardiomyopathies, Chagas Cardiomyopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingOther
| Study group | Role | What they receive |
|---|---|---|
| Exercise training group | Experimental | Exercise training is performed in subgroups of 6 patients supervised by two physiotherapists. Exercise prescription consisted of a 15-min warm-up, walking up to 30 min, followed by a 15-min cooling-down. The exercise intensity during the first 2 weeks corresponds to 55% at 65% of the HR peak reached at the baseline exercise test. In posterior sessions, individual adjustments are performed with gradual increases in order to reach the adequate target HR training intensity, as determined by the Karvonen formula {(maximal HR - HR at rest) x 50 to 70% + HR at rest}. Exercise training is performed in the morning, three times a week (on alternate days) for a total of 12 weeks (36 sessions). Receives: Other: Exercise training |
| Inactive control group | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional capacity
Measured: 12 weeks
Functional class
Measured: 12 weeks
Health related quality of life
Measured: 12 weeks
BNP levels
Measured: 12 weeks
Secondary outcomes (1)
Complications related to the exercise training
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2009 (estimated)
- Study startMar 2007
- Primary completionMar 2008
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Luiz Pinho Ribeiro, Federal University of Minas Gerais
- Investigators
- Antonio L Ribeiro, MD, PhD, Study chair, Federal University of Minas GeraisManoel Otávio C Rocha, MD, PhD, Principal investigator, Federal University if Minas GeraisMaria do Carmo P Nunes, MD, PhD, Study director, Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01006473
- Sponsor's protocol ID
- CNPq402024/2005-2
- Status last verified
- Aug 2015
- First submitted
- 1 Nov 2009
- Last updated
- 13 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lima MM, Rocha MO, Nunes MC, Sousa L, Costa HS, Alencar MC, Britto RR, Ribeiro AL. A randomized trial of the effects of exercise training in Chagas cardiomyopathy. Eur J Heart Fail. 2010 Aug;12(8):866-73. doi: 10.1093/eurjhf/hfq123.
PubMed 20675669Lima MM, Nunes MC, Nascimento B, Costa HS, Sousa LA, Teixeira AL, Rocha MO, Ribeiro AL. Improvement of the functional capacity is associated with BDNF and autonomic modulation in Chagas disease. Int J Cardiol. 2013 Sep 1;167(5):2363-6. doi: 10.1016/j.ijcard.2012.11.055. Epub 2012 Dec 8. No abstract available.
PubMed 23232458Lima MM, Nunes MC, Rocha MO, Beloti FR, Alencar MC, Ribeiro AL. Left ventricular diastolic function and exercise capacity in patients with Chagas cardiomyopathy. Echocardiography. 2010 May;27(5):519-24. doi: 10.1111/j.1540-8175.2009.01081.x. Epub 2010 Apr 16.
PubMed 20412275Nascimento BR, Lima MM, Nunes Mdo C, Alencar MC, Costa HS, Pinto Filho MM, Cota VE, Rocha MO, Ribeiro AL. Effects of exercise training on heart rate variability in Chagas heart disease. Arq Bras Cardiol. 2014 Sep;103(3):201-8. doi: 10.5935/abc.20140108. Epub 2014 Aug 1.
PubMed 25098373
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of the Effects of Exercise Training in Chagas Cardiomyopathy
- ClinicalTrials.gov ID
- NCT01006473
- Acronym / sponsor ID
- CNPq402024/2005-2
- Conditions
- Chagas Disease, Cardiomyopathy, Exercise Training
- Keywords
- Chagas Disease, Chagas Cardiomyopathy, Exercise Movement Techniques
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 2 Nov 2009 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise training group | Experimental | Other: Exercise trainingExercise training is performed in subgroups of 6 patients supervised by two physiotherapists. Exercise prescription consisted of a 15-min warm-up, walking up to 30 min, followed by a 15-min cooling-down. The exercise intensity during the first 2 weeks corresponds to 55% at 65% of the HR peak reached at the baseline exercise test. In posterior sessions, individual adjustments are performed with gradual increases in order to reach the adequate target HR training intensity, as determined by the Karvonen formula {(maximal HR - HR at rest) x 50 to 70% + HR at rest}. Exercise training is performed in the morning, three times a week (on alternate days) for a total of 12 weeks (36 sessions). |
| Inactive control group | No intervention | –No intervention |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Inability to attend regular exercise training
- The presence of a pacemaker, associated cardiac or systemic diseases
- Practitioners of regular physical activity
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 training | Other | Exercise training group |
Primary outcome
Functional capacity
Time frame: 12 weeks
Functional class
Time frame: 12 weeks
Health related quality of life
Time frame: 12 weeks
BNP levels
Time frame: 12 weeks
1 secondary outcome
Complications related to the exercise training
Time frame: 12 weeks
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 13 Aug 2015.
- Results publication: PubMed 20675669Lima MM, Rocha MO, Nunes MC, Sousa L, Costa HS, Alencar MC, Britto RR, Ribeiro AL. A randomized trial of the effects of exercise training in Chagas cardiomyopathy. Eur J Heart Fail. 2010 Aug;12(8):866-73. doi: 10.1093/eurjhf/hfq123.
- Results publication: PubMed 23232458Lima MM, Nunes MC, Nascimento B, Costa HS, Sousa LA, Teixeira AL, Rocha MO, Ribeiro AL. Improvement of the functional capacity is associated with BDNF and autonomic modulation in Chagas disease. Int J Cardiol. 2013 Sep 1;167(5):2363-6. doi: 10.1016/j.ijcard.2012.11.055. Epub 2012 Dec 8. No abstract available.
- Results publication: PubMed 20412275Lima MM, Nunes MC, Rocha MO, Beloti FR, Alencar MC, Ribeiro AL. Left ventricular diastolic function and exercise capacity in patients with Chagas cardiomyopathy. Echocardiography. 2010 May;27(5):519-24. doi: 10.1111/j.1540-8175.2009.01081.x. Epub 2010 Apr 16.
- Results publication: PubMed 25098373Nascimento BR, Lima MM, Nunes Mdo C, Alencar MC, Costa HS, Pinto Filho MM, Cota VE, Rocha MO, Ribeiro AL. Effects of exercise training on heart rate variability in Chagas heart disease. Arq Bras Cardiol. 2014 Sep;103(3):201-8. doi: 10.5935/abc.20140108. Epub 2014 Aug 1.
Related trials for Chagas Disease
Not yet recruitingObservational study
Assessment of the Risk of Zoonotic Infections in Prisons in French Guiana
Q Fever, Leptospirosis
RecruitingPhase 2
A Study of Efficacy, Safety, Tolerability of LXE408 in Participants With Chronic Chagas Disease.
Chagas Disease
Recruiting
Cardiac Contractility Modulation in Chagas Heart Disease
Chagas Cardiomyopathy, Heart Failure
Not yet recruitingObservational study
An Observational Pregnancy Safety Study in Women Who Were Exposed to the Drug Nifurtimox During Pregnancy to Learn About the Risk of Pregnancy Complications and About the Mother's and Baby's Health
Chagas Disease
Active, not recruitingPhase 3
Prospective Study of Benznidazole for Chagas' Disease Children With Chronic Indeterminate Chagas Disease
Chagas Disease
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.
Antonio L Ribeiro, MD, PhD study chair
Federal University of Minas Gerais
Manoel Otávio C Rocha, MD, PhD principal investigator
Federal University if Minas Gerais
Maria do Carmo P Nunes, MD, PhD study director
Federal University of Minas Gerais
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Exercise training in people with Chagas Disease and Cardiomyopathy, run by Federal University of Minas Gerais 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 4 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 13 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 (time frame: 12 weeks). The study lists 4 primary outcomes in all. 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 NCT01006473, which also lists 4 linked publications.
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 13 Aug 2015.