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Chemoreflex Control of Sympathetic Activity in Patients With Coronary Artery Disease

U

University of Sao Paulo General Hospital

Status

Unknown

Conditions

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

Treatments

Other: Aerobic exercise training

Study type

Interventional

Funder types

Other

Identifiers

NCT02624297
CAD-2015/01

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

35 to 60 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

50 participants in 5 patient groups

Control Group
No Intervention group
Description:
Healthy control group for comparisons with coronary artery disease groups.
CAD without OSA - Control
No Intervention group
Description:
Clinical follow-up.
CAD without OSA - Intervention
Experimental group
Description:
Aerobic exercise training.
Treatment:
Other: Aerobic exercise training
CAD with OSA - Control
No Intervention group
Description:
Clinical follow-up.
CAD with OSA - Intervention
Experimental group
Description:
Aerobic exercise training.
Treatment:
Other: Aerobic exercise training

Trial contacts and locations

1

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Central trial contact

Carlos Alcino do Nascimento Filho, BS; Maria Urbana PB Rondon, PhD

Data sourced from clinicaltrials.gov

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