Heart FailureNCT01939795
Effect of Physical Training Combined Cardiac Resynchronization Therapy in Heart Failure Patients
A study testing exercise training and/or CRT in people with Heart Failure, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
The investigators hypothesis that exercise training would potentiate the effects of cardiac resynchronization therapy in heart failure patients. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- exercise training and/or CRT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2009to Mar 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- QRS> 150 ms or 120-150ms associated dyssynchrony
- The etiology can be idiopathic, ischemic, hypertensive and Chagas' disease
- Ejection fraction <35%
- The optimal pharmacological treatment for heart failureExclusion Criteria:
Who cannot join
- Patients with pulmonary diseases, neurological diseases, renal, skeletal muscle diseases
- Patients with contraindications to implant a cardiac pacemaker
- Pregnancy
- New York Heart Association functional class IV
- Atrial fibrillation
Trial locations and contacts
1 site in 1 country.
About this study
The investigators hypothesis that exercise training would potentiate the effects of cardiac resynchronization therapy in heart failure patients.
- Conditions
- Heart Failure
- Being tested
- exercise training and/or CRT
- Keywords
- cardiac resynchronization therapy (CRT)
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise training and/or CRTOther
Also called Untrained CRT patients, Exercise-trained CRT patients
Three 40-minute exercise sessions per week on a treadmill for four months
| Study group | Role | What they receive |
|---|---|---|
| Healthy People | No intervention | Control group |
| Untrained CRT | Experimental | Untrained CRT patients Receives: Other: exercise training and/or CRT |
| Exercise trained + CRT | Experimental | Exercise-trained CRT patients Receives: Other: exercise training and/or CRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sympathetic nerve activity
Sympathetic nerve activity will be assessed by microneurography
Measured: 4 months
Secondary outcomes (5)
Peak oxygen consumption
Peak oxygen consumption will be determined by cardiopulmonary exercise testing
Measured: 4 months
Quality of life
Quality of life will be assessed by questionnaire
Measured: 4 months
Blood inflammatory markers
Blood inflammatory markers will be assessed by venipuncture
Measured: 4 months
skeletal muscle strength
Muscular evaluation will be done muscle gene expression
Measured: 4 months
Muscle Blood Flow
Forearm blood flow will be assessed by venous occlusion plethysmography
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 posted11 Sep 2013 (estimated)
- Study startJan 2009
- Primary completionSep 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Thaís Simões Nobre Pires Santos, University of Sao Paulo General Hospital
- Investigators
- Carlos E Negrao, Phd, Principal investigator, InCor, HCFMUSP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01939795
- Sponsor's protocol ID
- PT & CRT
- Status last verified
- Oct 2016
- First submitted
- 27 Mar 2013
- Last updated
- 25 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Physical Training Combined Cardiac Resynchronization Therapy in Heart Failure Patients
- ClinicalTrials.gov ID
- NCT01939795
- Acronym / sponsor ID
- PT & CRT
- Conditions
- Heart Failure
- Keywords
- cardiac resynchronization therapy (CRT)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Jan 2009
- Primary completion
- Sep 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 11 Sep 2013 (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 investigators hypothesis that exercise training would potentiate the effects of cardiac resynchronization therapy in heart failure patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy People | No intervention | –Control group |
| Untrained CRT | Experimental | Other: exercise training and/or CRTUntrained CRT patients |
| Exercise trained + CRT | Experimental | Other: exercise training and/or CRTExercise-trained CRT patients |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- QRS> 150 ms or 120-150ms associated dyssynchrony
- The etiology can be idiopathic, ischemic, hypertensive and Chagas' disease
- Ejection fraction <35%
- The optimal pharmacological treatment for heart failureExclusion Criteria:
Key exclusion criteria (5 listed)
- Patients with pulmonary diseases, neurological diseases, renal, skeletal muscle diseases
- Patients with contraindications to implant a cardiac pacemaker
- Pregnancy
- New York Heart Association functional class IV
- Atrial fibrillation
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 and/or CRTAlso: Untrained CRT patients, Exercise-trained CRT patientsThree 40-minute exercise sessions per week on a treadmill for four months | Other | Exercise trained + CRT, Untrained CRT |
Primary outcome
Sympathetic nerve activity
Time frame: 4 months
Sympathetic nerve activity will be assessed by microneurography
5 secondary outcomes
Peak oxygen consumption
Time frame: 4 months
Quality of life
Time frame: 4 months
Blood inflammatory markers
Time frame: 4 months
skeletal muscle strength
Time frame: 4 months
Muscle Blood Flow
Time frame: 4 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 25 Oct 2016.
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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.
Carlos E Negrao, Phd principal investigator
InCor, HCFMUSP
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 training and/or CRT in people with Heart Failure, 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 4 inclusion and 5 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 25 Oct 2016. 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?
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?
Sympathetic nerve activity (time frame: 4 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 25 Oct 2016.