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Clinical Trials/NCT03550872
NCT03550872
Completed
N/A

Effect of Exercise Training in Patients With Heart Failure and Permanent Atrial Fibrillation

University of Sao Paulo General Hospital1 site in 1 country13 target enrollmentJune 21, 2015

Overview

Phase
N/A
Intervention
Not specified
Conditions
Heart Failure
Sponsor
University of Sao Paulo General Hospital
Enrollment
13
Locations
1
Primary Endpoint
Functional Capacity Assessement
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

The positive effect of physical training in patients with heart failure (HF) has been increasingly established. However, the presence of atrial fibrillation (AF), mainly in its permanent form, makes the clinical condition of the patients more compromised.

Detailed Description

The positive effect of physical training in patients with heart failure (HF) has been increasingly established. However, the presence of atrial fibrillation (AF), mainly in its permanent form, makes the clinical picture of these patients more compromised. The literature has not yet demonstrated studies involving indication of physical exercise therapy when AF is associated with HF. Thus, the hypothesis is that physical training improves functional capacity, cerebral oxygenation, autonomic aspects, vascular aspects, cardiac function, plasma markers, quality of life and cognitive function of these patients.

Registry
clinicaltrials.gov
Start Date
June 21, 2015
End Date
October 30, 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients with clinically stable NYHA class II to III heart failure with permanent atrial fibrillation (AF);
  • Left ventricular ejection fraction ≤40%;
  • Patients refractory and / or no indication of the treatment of reversal to the rhythm;
  • Patients in optimization specific drug therapy for HF and AF.

Exclusion Criteria

  • High-frequency ventricular response;
  • Neuromuscular / neuropathy disease;
  • Physical and mental impairment;
  • Chronic obstructive pulmonary disease;
  • Diabetes mellitus;
  • Decompensated arterial hypertension;
  • Autonomic neuropathy;
  • Recent myocardial infarction (\<6 months);
  • Ventricular arrhythmias;
  • Atrial flutter;

Outcomes

Primary Outcomes

Functional Capacity Assessement

Time Frame: two year

unctional function is assessed by measuring oxygen consumption (VO2). Multidimensional electrocardiography logo will be connected to a computerized system through a remote and tracheal control system. Through Oxygen Detergent (O2) and carbon dioxide (CO2) the concentrations of O2 and CO2, respectively, are analyzed for each respiratory cycle.

Secondary Outcomes

  • Muscle Sympathetic Nervous Activity Assessment(Two year)
  • Measurement of Muscle Blood Flow(Two year)
  • Evaluation of endothelium-dependent vascular function(Two year)
  • Evaluation of neurovascular control during mental stress(Two)
  • Evaluation of the concentration of plasma biomarkers(Two year)
  • Assessment of cognitive function(Two year)
  • Evaluation of cardiac structure and function(Two year)
  • Quality of life assessment(Two year)
  • Measurement of Pulse Wave Velocity (PWV)(Two year)

Study Sites (1)

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