Chemoreflex Control of Sympathetic Activity in Patients With Coronary Artery Disease

Coronary Artery Disease (CAD) Clinical Trial

Official title:

Effect of Exercise Training on Chemoreflex Control of Sympathetic Activity in Patients With Coronary Artery Disease and Obstructive Sleep Apnea

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02624297
• Other study ID #: CAD-2015/01
• Status: Recruiting
• Phase: N/A
• First received: March 24, 2014
• Last updated: May 15, 2017
• Start date: January 2014
• Est. completion date: January 2020

Study information

• Verified date: May 2017
• Source: University of Sao Paulo General Hospital
• Contact: Maria Urbana PB Rondon, PhD
• Phone: 55 11 30918784
• Email: urbana[@]usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 2020
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Artery Disease (CAD)
• Coronary Disease
• Myocardial Ischemia
• Obstructive Sleep Apnea (OSA)
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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

Locations

Country	Name	City	State
Brazil	Heart Institute (InCor) - University of Sao Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

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