Heart FailureNCT01884142
Effects of Exercise Training on Mechanoreflex and Metaboreflex Control in Heart Failure Patients
A study testing Aerobic Exercise Training in people with Heart Failure, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
The investigators hypothesize that exercise training would improve the mechanoreflex and metaboreflex control in heart failure patients. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Aerobic Exercise Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2008to Jan 2014
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with systolic heart failure;
- New York Heart Association (NYHA) class II-III;
- Left ventricular ejection fraction less than 40%;
- Peak Oxygen Consumption less than 20 ml/Kg/min;
- Stable Clinical Status.
Who cannot join
- Chronic Obstructive Pulmonary Disease;
- Neuromuscular Diseases;
- Orthopedic Diseases;
- Neurologic Diseases;
- Neoplastic Diseases;
- Recent myocardial infarction or cardiac surgery (less than 6 months);
Show all 10Show fewer
- Unstable angina pectoris;
- Atrial Fibrillation;
- Pacemakers users;
- Changing medication or hospital admission.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Heart Institute (InCor), University of Sao Paulo Medical School
São Paulo, 05403-904
About this study
Official title: Effects of Exercise Training on Mechanoreflex and Metaboreflex Control of Muscle Sympathetic Nerve Activity in Heart Failure Patients
The investigators hypothesize that exercise training would improve the mechanoreflex and metaboreflex control in heart failure patients.
- Conditions
- Heart Failure
- Being tested
- Aerobic Exercise Training
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic Exercise TrainingOther
| Study group | Role | What they receive |
|---|---|---|
| Heart Failure Untrained Group | No intervention | Control Group |
| Heart Failure Exercise-trained Group | Experimental | Aerobic Exercise Training Receives: Other: Aerobic Exercise Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Autonomic Control
Mechanoreceptors were activated by passive exercise and metaboreceptors by post-exercise circulatory arrest
Measured: 4 months
Muscular Evaluation
Muscular evaluation will be done by muscle gene expression
Measured: 4 months
Secondary outcomes (3)
Functional Capacity
Functional Capacity will be determined by cardiopulmonary exercise testing
Measured: 4 months
Muscle Blood Flow
Forearm blood flow will be assessed by venous occlusion plethysmography
Measured: 4 months
Blood Pressure
Blood pressure will be monitored non-invasively
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 posted21 Jun 2013 (estimated)
- Study startMar 2008
- Primary completionDec 2012
- Study completionJan 2014
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 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
- 34 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, Lígia M. Antunes-Correa, University of Sao Paulo General Hospital
- Investigators
- Carlos E Negrão, PhD, Principal investigator, University of Sao Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01884142
- Sponsor's protocol ID
- Ergoreflex
- Status last verified
- Apr 2021
- First submitted
- 27 Mar 2013
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Unable to connect to PubMed to validate , last attempt on June 19, 2013 at 12:03 PM EDT
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exercise Training on Mechanoreflex and Metaboreflex Control of Muscle Sympathetic Nerve Activity in Heart Failure Patients
- ClinicalTrials.gov ID
- NCT01884142
- Acronym / sponsor ID
- Ergoreflex
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 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
- Mar 2008 (actual)
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 21 Jun 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 hypothesize that exercise training would improve the mechanoreflex and metaboreflex control in heart failure patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heart Failure Untrained Group | No intervention | –Control Group |
| Heart Failure Exercise-trained Group | Experimental | Other: Aerobic Exercise TrainingAerobic Exercise Training |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with systolic heart failure;
- New York Heart Association (NYHA) class II-III;
- Left ventricular ejection fraction less than 40%;
- Peak Oxygen Consumption less than 20 ml/Kg/min;
- Stable Clinical Status.
Key exclusion criteria (10 listed)
- Chronic Obstructive Pulmonary Disease;
- Neuromuscular Diseases;
- Orthopedic Diseases;
- Neurologic Diseases;
- Neoplastic Diseases;
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 |
|---|---|---|
| Aerobic Exercise Training | Other | Heart Failure Exercise-trained Group |
Primary outcome
Autonomic Control
Time frame: 4 months
Mechanoreceptors were activated by passive exercise and metaboreceptors by post-exercise circulatory arrest
Muscular Evaluation
Time frame: 4 months
Muscular evaluation will be done by muscle gene expression
3 secondary outcomes
Functional Capacity
Time frame: 4 months
Muscle Blood Flow
Time frame: 4 months
Blood Pressure
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 28 Apr 2021.
- BackgroundUnable to connect to PubMed to validate , last attempt on June 19, 2013 at 12:03 PM EDT
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
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 Negrão, PhD 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 Aerobic Exercise Training 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 5 inclusion and 10 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 28 Apr 2021. 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?
Autonomic Control (time frame: 4 months). The study lists 2 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 NCT01884142, 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 28 Apr 2021.