Effect of Physical Training Combined Cardiac Resynchronization Therapy in Heart Failure Patients

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Other: exercise training and/or CRT

• Registration Number: NCT01939795
• Lead Sponsor: University of Sao Paulo General Hospital

Brief Summary

The investigators hypothesis that exercise training would potentiate the effects of cardiac resynchronization therapy in heart failure patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2013-03-27
• Study First Submitted QC: 2013-09-05
• Study First Posted: 2013-09-11
• Primary Completion: 2014-09
• Study Completion: 2015-03
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-24
• Last Update Posted: 2016-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• QRS> 150 ms or 120-150ms associated dyssynchrony
• The etiology can be idiopathic, ischemic, hypertensive and Chagas' disease
• Ejection fraction <35%
• The optimal pharmacological treatment for heart failure

Exclusion Criteria

Exclusion Criteria:

• Patients with pulmonary diseases, neurological diseases, renal, skeletal muscle diseases
• Patients with contraindications to implant a cardiac pacemaker
• Pregnancy
• New York Heart Association functional class IV
• Atrial fibrillation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Untrained CRT	exercise training and/or CRT	Untrained CRT patients
Exercise trained + CRT	exercise training and/or CRT	Exercise-trained CRT patients

Primary Outcome Measures

Name	Time	Method
Sympathetic nerve activity	4 months	Sympathetic nerve activity will be assessed by microneurography

Secondary Outcome Measures

Name	Time	Method
Peak oxygen consumption	4 months	Peak oxygen consumption will be determined by cardiopulmonary exercise testing
Muscle Blood Flow	4 months	Forearm blood flow will be assessed by venous occlusion plethysmography
skeletal muscle strength	4 months	Muscular evaluation will be done muscle gene expression
Quality of life	4 months	Quality of life will be assessed by questionnaire
Blood inflammatory markers	4 months	Blood inflammatory markers will be assessed by venipuncture

Trial Locations

Locations (1)

Thais Simoes Nobre Pires Santos; 🇧🇷 São Paulo, SP, Brazil