Clinical trial NCT02624297: Chemoreflex Control of Sympathetic Activity in Patients With Coronary Artery Disease
Official title: Effect of Exercise Training on Chemoreflex Control of Sympathetic Activity in Patients With Coronary Artery Disease and Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease (CAD)
Obstructive Sleep Apnea (OSA)
Keywords: Coronary artery disease
Chemoreceptors
Sympathetic nerve activity
Exercise
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2015-12-08
Enrollment: 50
Sex: ALL
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Chemoreflex control of MSNA at rest and during exercise.
timeFrame: baseline and after 4 months
Secondary outcomes:
measure: Endothelial Function
timeFrame: baseline and after 4 months
measure: Neurovascular Control
timeFrame: baseline and after 4 months
measure: Inflammatory markers
timeFrame: baseline and after 4 months
measure: Quality of Life
timeFrame: baseline and after 4 months
measure: Anxiety Trait and State
timeFrame: baseline and after 4 months
measure: Symptoms of Depression
timeFrame: baseline and after 4 months
measure: Mood State
timeFrame: baseline and after 4 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Heart Institute (InCor) - University of Sao Paulo
Study officials:
affiliation: University of Sao Paulo
name: Maria Urbana PB Rondon, PhD
role: PRINCIPAL_INVESTIGATOR
References: