Back to resultsChemoreflex Control of Sympathetic Activity in Patients With Coronary Artery Disease
Primary Purpose
Coronary Artery Disease (CAD), Obstructive Sleep Apnea (OSA)
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Aerobic exercise training
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease (CAD) focused on measuring Coronary artery disease, Chemoreceptors, Sympathetic nerve activity, Exercise
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.
Sites / Locations
- Heart Institute (InCor) - University of Sao PauloRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
No Intervention
No Intervention
Experimental
No Intervention
Experimental
Arm Label
Control Group
CAD without OSA - Control
CAD without OSA - Intervention
CAD with OSA - Control
CAD with OSA - Intervention
Arm Description
Healthy control group for comparisons with coronary artery disease groups.
Clinical follow-up.
Aerobic exercise training.
Clinical follow-up.
Aerobic exercise training.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Endothelial Function
Endothelial Function will be measured by markers present in blood samples.
Neurovascular Control
Neurovascular Control will be measured by venous occlusion plethysmography technique during the exposure mixture of gases known at rest and during exercise.
Inflammatory markers
Inflammatory markers will be measured by markers present in blood samples.
Quality of Life
Quality of life will be measured by the questionnaire Short-Form Health Survey (SF-36).
Anxiety Trait and State
Anxiety Trait and State will be measured by the Spielberger state trait anxiety inventory (STAI).
Symptoms of Depression
The level of symptoms of depression will be measured by the Beck scale.
Mood State
Mood State will be measured by the profile of mood states (POMS) scale.
Full Information
NCT ID
NCT02624297
First Posted
March 24, 2014
Last Updated
May 15, 2017
Sponsor
University of Sao Paulo General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02624297
Brief Title
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
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
January 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease (CAD), Obstructive Sleep Apnea (OSA)
Keywords
Coronary artery disease, Chemoreceptors, Sympathetic nerve activity, Exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Healthy control group for comparisons with coronary artery disease groups.
Arm Title
CAD without OSA - Control
Arm Type
No Intervention
Arm Description
Clinical follow-up.
Arm Title
CAD without OSA - Intervention
Arm Type
Experimental
Arm Description
Aerobic exercise training.
Arm Title
CAD with OSA - Control
Arm Type
No Intervention
Arm Description
Clinical follow-up.
Arm Title
CAD with OSA - Intervention
Arm Type
Experimental
Arm Description
Aerobic exercise training.
Intervention Type
Other
Intervention Name(s)
Aerobic exercise training
Intervention Description
The patients will be submitted to four months of aerobic exercise training, three time a week.
Primary Outcome Measure Information:
Title
Chemoreflex control of MSNA at rest and during exercise.
Description
Chemoreflex control of MSNA will be measured by microneurography technique during the gas mixture known exposure at rest and during exercise
Time Frame
baseline and after 4 months
Secondary Outcome Measure Information:
Title
Endothelial Function
Description
Endothelial Function will be measured by markers present in blood samples.
Time Frame
baseline and after 4 months
Title
Neurovascular Control
Description
Neurovascular Control will be measured by venous occlusion plethysmography technique during the exposure mixture of gases known at rest and during exercise.
Time Frame
baseline and after 4 months
Title
Inflammatory markers
Description
Inflammatory markers will be measured by markers present in blood samples.
Time Frame
baseline and after 4 months
Title
Quality of Life
Description
Quality of life will be measured by the questionnaire Short-Form Health Survey (SF-36).
Time Frame
baseline and after 4 months
Title
Anxiety Trait and State
Description
Anxiety Trait and State will be measured by the Spielberger state trait anxiety inventory (STAI).
Time Frame
baseline and after 4 months
Title
Symptoms of Depression
Description
The level of symptoms of depression will be measured by the Beck scale.
Time Frame
baseline and after 4 months
Title
Mood State
Description
Mood State will be measured by the profile of mood states (POMS) scale.
Time Frame
baseline and after 4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Urbana PB Rondon, PhD
Phone
55 11 30918784
Email
urbana@usp.br
First Name & Middle Initial & Last Name or Official Title & Degree
Carlos Alcino do Nascimento Filho, BS
Phone
55 1126615099
Email
carlosalcinofilho@yahoo.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Urbana PB Rondon, PhD
Organizational Affiliation
University of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Heart Institute (InCor) - University of Sao Paulo
City
São Paulo
ZIP/Postal Code
05403-900
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Urbana PB Rondon, PhD
Phone
55 11 30913183
Email
urbana@usp.br
First Name & Middle Initial & Last Name & Degree
Carlos Alcino do Nascimento Filho, BS
Phone
55 11 26615099
Email
carlosalcinofilho@yahoo.com.br
First Name & Middle Initial & Last Name & Degree
Carlos Eduardo Negrão, PhD
First Name & Middle Initial & Last Name & Degree
Maria Janieire NN Alves, MD PhD
First Name & Middle Initial & Last Name & Degree
Edgar Toschi-Dias, PhD
First Name & Middle Initial & Last Name & Degree
Larissa F dos Santos, BS
12. IPD Sharing Statement
Learn more about this trial
Chemoreflex Control of Sympathetic Activity in Patients With Coronary Artery Disease
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