Chemoreflex Control of Sympathetic Activity in Patients With Coronary Artery Disease

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease (CAD); Obstructive Sleep Apnea (OSA)
• Intervention / Treatment: Other: Aerobic exercise training

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 05403-900
    • Recruiting
    • Heart Institute (InCor) - University of Sao Paulo
    • Contact: Maria Urbana PB Rondon, PhD; Phone Number: 55 11 30913183; Email: urbana@usp.br
    • Contact: Carlos Alcino do Nascimento Filho, BS; Phone Number: 55 11 26615099; Email: carlosalcinofilho@yahoo.com.br
    • Sub-Investigator: Carlos Eduardo Negrão, PhD
    • Sub-Investigator: Maria Janieire NN Alves, MD PhD
    • Sub-Investigator: Edgar Toschi-Dias, PhD
    • Sub-Investigator: Larissa F dos Santos, BS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; Healthy control group for comparisons with coronary artery disease groups.
No Intervention: CAD without OSA - Control; Clinical follow-up.
Experimental: CAD without OSA - Intervention; Aerobic exercise training.	Other: Aerobic exercise training; The patients will be submitted to four months of aerobic exercise training, three time a week.
No Intervention: CAD with OSA - Control; Clinical follow-up.
Experimental: CAD with OSA - Intervention; Aerobic exercise training.	Other: Aerobic exercise training; The patients will be submitted to four months of aerobic exercise training, three time a week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	baseline and after 4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endothelial Function	Endothelial Function will be measured by markers present in blood samples.	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.	baseline and after 4 months
Inflammatory markers	Inflammatory markers will be measured by markers present in blood samples.	baseline and after 4 months
Quality of Life	Quality of life will be measured by the questionnaire Short-Form Health Survey (SF-36).	baseline and after 4 months
Anxiety Trait and State	Anxiety Trait and State will be measured by the Spielberger state trait anxiety inventory (STAI).	baseline and after 4 months
Symptoms of Depression	The level of symptoms of depression will be measured by the Beck scale.	baseline and after 4 months
Mood State	Mood State will be measured by the profile of mood states (POMS) scale.	baseline and after 4 months

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Investigators: Principal Investigator: Maria Urbana PB Rondon, PhD, University of Sao Paulo

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): January 1, 2020

Study Registration Dates

• First Submitted: March 24, 2014
• First Submitted That Met QC Criteria: December 7, 2015
• First Posted (Estimate): December 8, 2015

Study Record Updates

• Last Update Posted (Actual): May 16, 2017
• Last Update Submitted That Met QC Criteria: May 15, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Exercise; Coronary artery disease; Sympathetic nerve activity; Chemoreceptors
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Respiratory Tract Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: CAD-2015/01