Chemoreflex Control of Sympathetic Activity in Patients With Coronary Artery Disease

Not Applicable

• Conditions: Obstructive Sleep Apnea (OSA); Coronary Artery Disease (CAD)
• Interventions: Other: Aerobic exercise training

• Registration Number: NCT02624297
• Lead Sponsor: University of Sao Paulo General Hospital

Brief 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. 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 Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-03-24
• Study First Submitted QC: 2015-12-07
• Study First Posted: 2015-12-08
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-15
• Last Update Posted: 2017-05-16
• Primary Completion: 2017-12
• Study Completion: 2020-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CAD without OSA - Intervention	Aerobic exercise training	Aerobic exercise training.
CAD with OSA - Intervention	Aerobic exercise training	Aerobic exercise training.

Primary Outcome Measures

Name	Time	Method
Chemoreflex control of MSNA at rest and during exercise.	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

Secondary Outcome Measures

Name	Time	Method
Endothelial Function	baseline and after 4 months	Endothelial Function will be measured by markers present in blood samples.
Neurovascular Control	baseline and after 4 months	Neurovascular Control will be measured by venous occlusion plethysmography technique during the exposure mixture of gases known at rest and during exercise.
Inflammatory markers	baseline and after 4 months	Inflammatory markers will be measured by markers present in blood samples.
Quality of Life	baseline and after 4 months	Quality of life will be measured by the questionnaire Short-Form Health Survey (SF-36).
Mood State	baseline and after 4 months	Mood State will be measured by the profile of mood states (POMS) scale.
Anxiety Trait and State	baseline and after 4 months	Anxiety Trait and State will be measured by the Spielberger state trait anxiety inventory (STAI).
Symptoms of Depression	baseline and after 4 months	The level of symptoms of depression will be measured by the Beck scale.

Trial Locations

Locations (1)

Heart Institute (InCor) - University of Sao Paulo; 🇧🇷 São Paulo, Brazil