Clinical trial NCT02219451: Exercise Improve Sympathetic Modulation in Chronic Heart Failure Patients
Official title: Exercise Training Improves Oscillatory Pattern and Arterial Baroreflex Control of Sympathetic Nerve Activity in Patients With Chronic Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Heart Failure
Keywords: Chronic heart failure
exercise training
Sympathetic modulation
arterial baroreflex control
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: InCor Heart Institute
First posted: 2014-08-19
Enrollment: 26
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to verify the effects of exercise training on sympathetic modulation and arterial baroreflex control in patients with chronic heart failure.

Detailed description: Retrospective study. Patients were recruited by database from Rehabilitation Unit of Cardiovascular Rehabilitation and Exercise Physiology of the Heart Institute (InCor). The aim of this study is to assess the effects of exercise training on sympathetic modulation and arterial baroreflex control in patients with chronic heart failure. The investigators studied twenty-six chronic heart failure outpatients, age 30 to 70 years, functional class II to III of New York Heart Association, left ventricular ejection fraction (LVEF) ≤40% and peak oxygen uptake (VO2) ≤20. The exclusion criteria were recent myocardial infarction or unstable angina (\<3 months), heart failure duration (\<3 months), permanent pacemaker dependence, atrial fibrillation, skeletal muscle abnormality (e.g., arthritis) and participation in a regular exercise program. They were assigned to 2 groups: Untrained (n=13) and trained (n=13).

Eligibility criteria: Inclusion Criteria:

* Patients with chronic heart failure
* Age 30 to 70 years
* Functional class II to III of New York Heart Association
* Left ventricular ejection fraction (LVEF) ≤40%
* Peak oxygen uptake (VO2) ≤20

Exclusion Criteria:

* Recent myocardial infarction or unstable angina (\<3 months)
* heart failure duration (\<3 months)
* Permanent pacemaker dependence
* Atrial fibrillation
* Skeletal muscle abnormality (e.g., arthritis)
* Participation in a regular exercise program

Primary outcomes:
measure: Autonomic control
timeFrame: 4 months
Secondary outcomes:
measure: Arterial baroreflex control
timeFrame: 4 months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Instituto do Coração - HC/FMUSP
Study officials:
affiliation: Heart Institute, University of Sao Paulo
name: Heart Institute HC/FMUSP, HC/FMUSP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Groehs RV, Toschi-Dias E, Antunes-Correa LM, Trevizan PF, Rondon MU, Oliveira P, Alves MJ, Almeida DR, Middlekauff HR, Negrao CE. Exercise training prevents the deterioration in the arterial baroreflex control of sympathetic nerve activity in chronic heart failure patients. Am J Physiol Heart Circ Physiol. 2015 May 1;308(9):H1096-102. doi: 10.1152/ajpheart.00723.2014. Epub 2015 Mar 6.