Exercise Training in Patients With Heart Failure and Permanent Atrial Fibrillation

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03550872
• Date of registration: 23/05/2018
• Prospective Registration: No
• Primary sponsor: University of Sao Paulo General Hospital
• Public title: Exercise Training in Patients With Heart Failure and Permanent Atrial Fibrillation
• Scientific title: Effect of Exercise Training in Patients With Heart Failure and Permanent Atrial Fibrillation
• Date of first enrolment: June 21, 2015
• Target sample size: 13
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03550872
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Brazil

Contacts

• Name: Guilherme Veiga Guimarães
• Affiliation: Institute of Heart of the Sao Paulo University

Key inclusion & exclusion 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.



Age minimum: 30 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Heart Failure

Atrial Fibrillation

Intervention(s)

Behavioral: Physical Training

Primary Outcome(s)

Functional Capacity Assessement [Time Frame: two year]

Secondary Outcome(s)

Evaluation of the concentration of plasma biomarkers [Time Frame: Two year]

Evaluation of cardiac structure and function [Time Frame: Two year]

Measurement of Pulse Wave Velocity (PWV) [Time Frame: Two year]

Assessment of cognitive function [Time Frame: Two year]

Muscle Sympathetic Nervous Activity Assessment [Time Frame: Two year]

Quality of life assessment [Time Frame: Two year]

Evaluation of endothelium-dependent vascular function [Time Frame: Two year]

Evaluation of neurovascular control during mental stress [Time Frame: Two]

Measurement of Muscle Blood Flow [Time Frame: Two year]

Secondary ID(s)

Heart of Institute

Source(s) of Monetary Support

Please refer to primary and secondary sponsors