NCT02624297

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2014

Completed
1.7 years until next milestone

First Posted

Study publicly available on registry

December 8, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

May 16, 2017

Status Verified

May 1, 2017

Enrollment Period

3.9 years

First QC Date

March 24, 2014

Last Update Submit

May 15, 2017

Conditions

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

Keywords

Coronary artery diseaseChemoreceptorsSympathetic nerve activityExercise

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Endothelial Function

    baseline and after 4 months

  • Neurovascular Control

    baseline and after 4 months

  • Inflammatory markers

    baseline and after 4 months

  • Quality of Life

    baseline and after 4 months

  • Anxiety Trait and State

    baseline and after 4 months

  • +2 more secondary outcomes

Study Arms (5)

Control Group

NO INTERVENTION

Healthy control group for comparisons with coronary artery disease groups.

CAD without OSA - Control

NO INTERVENTION

Clinical follow-up.

CAD without OSA - Intervention

EXPERIMENTAL

Aerobic exercise training.

Other: Aerobic exercise training

CAD with OSA - Control

NO INTERVENTION

Clinical follow-up.

CAD with OSA - Intervention

EXPERIMENTAL

Aerobic exercise training.

Other: Aerobic exercise training

Interventions

Aerobic exercise trainingOTHER

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

CAD with OSA - InterventionCAD without OSA - Intervention

Eligibility Criteria

Age35 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heart Institute (InCor) - University of Sao Paulo

São Paulo, 05403-900, Brazil

RECRUITING

MeSH Terms

Conditions

Coronary Artery DiseaseSleep Apnea, ObstructiveMotor Activity

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesSleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesBehavior

Study Officials

  • Maria Urbana PB Rondon, PhD

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Urbana PB Rondon, PhD

CONTACT

55 11 30918784urbana@usp.br

Carlos Alcino do Nascimento Filho, BS

CONTACT

55 1126615099carlosalcinofilho@yahoo.com.br

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2014

First Posted

December 8, 2015

Study Start

January 1, 2014

Primary Completion

December 1, 2017

Study Completion

January 1, 2020

Last Updated

May 16, 2017

Record last verified: 2017-05

Locations

BR(1)