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Status unknownNCT02624297Updated May 16, 2017

Chemoreflex Control of Sympathetic Activity in Patients With Coronary Artery Disease

An interventional study of Aerobic exercise training in Coronary Artery Disease (CAD) and Obstructive Sleep Apnea (OSA), sponsored by University of Sao Paulo General Hospital. Status unknown at 1 site in Brazil. Open to participants aged 35 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-05-16.

Sponsored by University of Sao Paulo General Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
35 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • Coronary artery disease
  • Chemoreceptors
  • Sympathetic nerve activity
  • Exercise
03

In context

Sleep Apnea Syndromes

2,162 studies on the registry are indexed under Sleep Apnea Syndromes; 290 are open to participants now.

This study's planned enrollment of 50 is close to the median of 53 across 1,386 interventional studies indexed under Sleep Apnea Syndromes.

Browse Sleep Apnea Syndromes studies →

Lead sponsor

University of Sao Paulo General Hospital is the lead sponsor of 595 studies on the registry; 98 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • 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

  • No intervention
    CAD with OSA - Control

    Clinical follow-up.

  • Experimental
    CAD with OSA - Intervention

    Aerobic exercise training.

    Other: Aerobic exercise training

Interventions

  • OtherAerobic exercise training

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

06

What researchers measure

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

    Time frame: baseline and after 4 months

Secondary outcomes

  1. Endothelial Function

    Endothelial Function will be measured by markers present in blood samples.

    Time frame: baseline and after 4 months

  2. Neurovascular Control

    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

  3. Inflammatory markers

    Inflammatory markers will be measured by markers present in blood samples.

    Time frame: baseline and after 4 months

  4. Quality of Life

    Quality of life will be measured by the questionnaire Short-Form Health Survey (SF-36).

    Time frame: baseline and after 4 months

  5. Anxiety Trait and State

    Anxiety Trait and State will be measured by the Spielberger state trait anxiety inventory (STAI).

    Time frame: baseline and after 4 months

  6. Symptoms of Depression

    The level of symptoms of depression will be measured by the Beck scale.

    Time frame: baseline and after 4 months

  7. Mood State

    Mood State will be measured by the profile of mood states (POMS) scale.

    Time frame: baseline and after 4 months

07

Study locations

1 of 1 sites recruiting
  • Heart Institute (InCor) - University of Sao Paulo
    São Paulo, 05403-900, Brazil
    • Maria Urbana PB Rondon, PhD · Contact · urbana@usp.br · 55 11 30913183
    • Carlos Alcino do Nascimento Filho, BS · Contact · carlosalcinofilho@yahoo.com.br · 55 11 26615099
    • 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 · Sub investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 16, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02624297
Lead sponsor
University of Sao Paulo General Hospital
Responsible party
Sponsor
First posted
Dec 8, 2015
Start date
Jan 2014
Primary completion
Dec 2017 (estimated)
Completion
Jan 2020 (estimated)
Last update
May 16, 2017

Study contacts

Maria Urbana PB Rondon, PhD
Contact
urbana@usp.br
55 11 30918784
Carlos Alcino do Nascimento Filho, BS
Contact
carlosalcinofilho@yahoo.com.br
55 1126615099
Maria Urbana PB Rondon, PhD
principal investigator · University of Sao Paulo

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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