Coronary Artery Disease (CAD)NCT02624297
Chemoreflex Control of Sympathetic Activity in Patients With Coronary Artery Disease
A study testing Aerobic exercise training in people with Coronary Artery Disease (CAD) and Obstructive Sleep Apnea (OSA), run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
The investigators hypothesize that chemoreflex response of muscle sympathetic nerve activity (MSNA) during hypoxia and hypercapnia will be increased in coronary artery disease (CAD) patients and that the presence of obstructive sleep apnea (OSA) will potentiate these responses. Read more about this study
- Who is it for?
- Ages 35 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease (CAD), Obstructive Sleep Apnea (OSA)
- What is being tested?
- Aerobic exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2014to Jan 2020
- 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 35 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Diagnosis of stable coronary artery disease; Age between 35-60 years, male and female; BMI <30 kg/m2 Not involved in a regular exercise program at least three months before the survey;
Who cannot join
- Patients with angina and / or ischemia,
- Patients with diabetic neuropathy and / or ischemia of the lower limbs;
- Previous diagnosis of chronic pulmonary, neurological and orthopedic diseases, neoplasia, renal failure and insulin-dependent diabetes mellitus;
- Patients with acute myocardial infarction, cardiac surgery or hospitalization of cardiac origin six months before the study and carriers of pacemaker / implantable defibrillator;
- Patients with cardiac dysfunction (ejection fraction of left ventricle <40%);
- Current smoking and pregnant women.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Heart Institute (InCor) - University of Sao Paulo
São Paulo, 05403-900
Maria Urbana PB Rondon, PhD, 55 11 30913183, urbana@usp.br
Carlos Alcino do Nascimento Filho, BS, 55 11 26615099, carlosalcinofilho@yahoo.com.br
About this study
Official title: Effect of Exercise Training on Chemoreflex Control of Sympathetic Activity in Patients With Coronary Artery Disease and Obstructive Sleep Apnea
The investigators hypothesize that chemoreflex response of muscle sympathetic nerve activity (MSNA) during hypoxia and hypercapnia will be increased in coronary artery disease (CAD) patients and that the presence of obstructive sleep apnea (OSA) will potentiate these responses. And, that the exercise training would decrease the chemoreflex response of MSNA in these patients.
Read the detailed description
Forty patients with coronary artery disease, with (n=20) and without (n=20) obstructive sleep apnea will be studied. A healthy control, age-paired group (n=10) will be also evaluated. The patients will be submitted to a polysomnography and randomized for clinical follow-up or exercise training for four months. It will evaluated the autonomic function, chemoreflex control of sympathetic activity during hypoxic and hypercapnic maneuvers, endothelial function and inflammatory markers.
- Being tested
- Aerobic exercise training
- Keywords
- Coronary artery disease, Chemoreceptors, Sympathetic nerve activity, Exercise
- Medical subject headings
- Coronary Artery Disease, Sleep Apnea, Obstructive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exercise trainingOther
The patients will be submitted to four months of aerobic exercise training, three time a week.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Healthy control group for comparisons with coronary artery disease groups. |
| CAD without OSA - Control | No intervention | Clinical follow-up. |
| CAD without OSA - Intervention | Experimental | Aerobic exercise training. Receives: Other: Aerobic exercise training |
| CAD with OSA - Control | No intervention | Clinical follow-up. |
| CAD with OSA - Intervention | 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.
Chemoreflex control of MSNA at rest and during exercise.
Chemoreflex control of MSNA will be measured by microneurography technique during the gas mixture known exposure at rest and during exercise
Measured: baseline and after 4 months
Secondary outcomes (7)
Endothelial Function
Endothelial Function will be measured by markers present in blood samples.
Measured: baseline and after 4 months
Neurovascular Control
Neurovascular Control will be measured by venous occlusion plethysmography technique during the exposure mixture of gases known at rest and during exercise.
Measured: baseline and after 4 months
Inflammatory markers
Inflammatory markers will be measured by markers present in blood samples.
Measured: baseline and after 4 months
Quality of Life
Quality of life will be measured by the questionnaire Short-Form Health Survey (SF-36).
Measured: baseline and after 4 months
Anxiety Trait and State
Anxiety Trait and State will be measured by the Spielberger state trait anxiety inventory (STAI).
Measured: baseline and after 4 months
Symptoms of Depression
The level of symptoms of depression will be measured by the Beck scale.
Measured: baseline and after 4 months
Mood State
Mood State will be measured by the profile of mood states (POMS) scale.
Measured: baseline and after 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2015 (estimated)
- Study startJan 2014
- Primary completionDec 2017 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Disease (CAD)Studies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Urbana PB Rondon, PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02624297
- Sponsor's protocol ID
- CAD-2015/01
- Status last verified
- May 2017
- First submitted
- 24 Mar 2014
- Last updated
- 16 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Exercise Training on Chemoreflex Control of Sympathetic Activity in Patients With Coronary Artery Disease and Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT02624297
- Acronym / sponsor ID
- CAD-2015/01
- Keywords
- Coronary artery disease, Chemoreceptors, Sympathetic nerve activity, Exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 8 Dec 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.
The investigators hypothesize that chemoreflex response of muscle sympathetic nerve activity (MSNA) during hypoxia and hypercapnia will be increased in coronary artery disease (CAD) patients and that the presence of obstructive sleep apnea (OSA) will potentiate these responses. And, that the exercise training would decrease the chemoreflex response of MSNA in these patients.
Detailed description
Forty patients with coronary artery disease, with (n=20) and without (n=20) obstructive sleep apnea will be studied. A healthy control, age-paired group (n=10) will be also evaluated. The patients will be submitted to a polysomnography and randomized for clinical follow-up or exercise training for four months. It will evaluated the autonomic function, chemoreflex control of sympathetic activity during hypoxic and hypercapnic maneuvers, endothelial function and inflammatory markers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Healthy control group for comparisons with coronary artery disease groups. |
| CAD without OSA - Control | No intervention | –Clinical follow-up. |
| CAD without OSA - Intervention | Experimental | Other: Aerobic exercise trainingAerobic exercise training. |
| CAD with OSA - Control | No intervention | –Clinical follow-up. |
| CAD with OSA - Intervention | Experimental | Other: Aerobic exercise trainingAerobic exercise training. |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Diagnosis of stable coronary artery disease; Age between 35-60 years, male and female; BMI <30 kg/m2 Not involved in a regular exercise program at least three months before the survey;
Key exclusion criteria (6 listed)
- Patients with angina and / or ischemia,
- Patients with diabetic neuropathy and / or ischemia of the lower limbs;
- Previous diagnosis of chronic pulmonary, neurological and orthopedic diseases, neoplasia, renal failure and insulin-dependent diabetes mellitus;
- Patients with acute myocardial infarction, cardiac surgery or hospitalization of cardiac origin six months before the study and carriers of pacemaker / implantable defibrillator;
- Patients with cardiac dysfunction (ejection fraction of left ventricle <40%);
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 trainingThe patients will be submitted to four months of aerobic exercise training, three time a week. | Other | CAD with OSA - Intervention, CAD without OSA - Intervention |
Primary outcome
Chemoreflex control of MSNA at rest and during exercise.
Time frame: baseline and after 4 months
Chemoreflex control of MSNA will be measured by microneurography technique during the gas mixture known exposure at rest and during exercise
7 secondary outcomes
Endothelial Function
Time frame: baseline and after 4 months
Neurovascular Control
Time frame: baseline and after 4 months
Inflammatory markers
Time frame: baseline and after 4 months
Quality of Life
Time frame: baseline and after 4 months
Anxiety Trait and State
Time frame: baseline and after 4 months
Symptoms of Depression
Time frame: baseline and after 4 months
Mood State
Time frame: baseline and after 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2017.
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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.
Maria Urbana PB Rondon, PhD principal investigator
University of Sao Paulo
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 Coronary Artery Disease (CAD) and Obstructive Sleep Apnea (OSA), 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 1 inclusion and 6 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 16 May 2017. 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 Maria Urbana PB Rondon, PhD (55 11 30918784, urbana@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chemoreflex control of MSNA at rest and during exercise. (time frame: baseline and after 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 16 May 2017.