Clinical trial NCT03550872: Exercise Training in Patients With Heart Failure and Permanent Atrial Fibrillation
Official title: Effect of Exercise Training in Patients With Heart Failure and Permanent Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Atrial Fibrillation
Keywords: heart failure, atrial fibrillation and exercise training
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2018-06-08
Enrollment: 13
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: To evaluate the physical effect of physical training in patients with heart failure and permanent atrial fibrillation
Primary purpose: OTHER

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.

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;
* Renal failure;
* Use implantable electronic cardiac device or indication for implantation;
* Pregnancy;
* NYHA Functional Class IV;
* Resting heart rate \<55 bpm;
* Wolff Parkinson White Syndrome;
* Thyroid dysfunction;
* Unstable angina;
* Recent history of thromboembolic event;
* Inability to sign the consent form;
* Participation in regular physical training program;
* Use of alcoholic beverages.

Primary outcomes:
measure: Functional Capacity Assessement
timeFrame: two year
Secondary outcomes:
measure: Muscle Sympathetic Nervous Activity Assessment
timeFrame: Two year
measure: Measurement of Muscle Blood Flow
timeFrame: Two year
measure: Evaluation of endothelium-dependent vascular function
timeFrame: Two year
measure: Evaluation of neurovascular control during mental stress
timeFrame: Two
measure: Measurement of Pulse Wave Velocity (PWV)
timeFrame: Two year
measure: Evaluation of cardiac structure and function
timeFrame: Two year
measure: Evaluation of the concentration of plasma biomarkers
timeFrame: Two year
measure: Quality of life assessment
timeFrame: Two year
measure: Assessment of cognitive function
timeFrame: Two year
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Heart Institute of Hospiral Clinics of the University of São Paulo Medical School
state: SP
Study officials:
affiliation: Institute of Heart of the Sao Paulo University
name: Guilherme Veiga Guimarães
role: PRINCIPAL_INVESTIGATOR
References: