Chemoreflex Control of Sympathetic Activity in Patients With Coronary Artery Disease

NCT ID: NCT02624297

Last Updated: 2017-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2020-01-31

Brief Summary

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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

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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.

Conditions

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Coronary Artery Disease (CAD) Obstructive Sleep Apnea (OSA)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control Group

Healthy control group for comparisons with coronary artery disease groups.

Group Type NO_INTERVENTION

No interventions assigned to this group

CAD without OSA - Control

Clinical follow-up.

Group Type NO_INTERVENTION

No interventions assigned to this group

CAD without OSA - Intervention

Aerobic exercise training.

Group Type EXPERIMENTAL

Aerobic exercise training

Intervention Type OTHER

The patients will be submitted to four months of aerobic exercise training, three time a week.

CAD with OSA - Control

Clinical follow-up.

Group Type NO_INTERVENTION

No interventions assigned to this group

CAD with OSA - Intervention

Aerobic exercise training.

Group Type EXPERIMENTAL

Aerobic exercise training

Intervention Type OTHER

The patients will be submitted to four months of aerobic exercise training, three time a week.

Interventions

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Aerobic exercise training

The patients will be submitted to four months of aerobic exercise training, three time a week.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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;

Exclusion Criteria

* 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.
Minimum Eligible Age

35 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maria Urbana PB Rondon, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

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Heart Institute (InCor) - University of Sao Paulo

São Paulo, , Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Maria Urbana PB Rondon, PhD

Role: CONTACT

55 11 30918784

Carlos Alcino do Nascimento Filho, BS

Role: CONTACT

55 1126615099

Facility Contacts

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Maria Urbana PB Rondon, PhD

Role: primary

55 11 30913183

Carlos Alcino do Nascimento Filho, BS

Role: backup

55 11 26615099

Other Identifiers

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CAD-2015/01

Identifier Type: -

Identifier Source: org_study_id

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