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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01939795
• Other study ID #: PT & CRT
• Status: Completed
• Phase: N/A
• First received: March 27, 2013
• Last updated: October 24, 2016
• Start date: January 2009
• Est. completion date: March 2015

Study information

• Verified date: October 2016
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 failureExclusion 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• exercise training and/or CRT
Three 40-minute exercise sessions per week on a treadmill for four months

Locations

Country	Name	City	State
Brazil	Thais Simoes Nobre Pires Santos	São Paulo	SP

Sponsors (3)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sympathetic nerve activity	Sympathetic nerve activity will be assessed by microneurography	4 months	No
Secondary	Peak oxygen consumption	Peak oxygen consumption will be determined by cardiopulmonary exercise testing	4 months	No
Secondary	Quality of life	Quality of life will be assessed by questionnaire	4 months	No
Secondary	Blood inflammatory markers	Blood inflammatory markers will be assessed by venipuncture	4 months	No
Secondary	skeletal muscle strength	Muscular evaluation will be done muscle gene expression	4 months	No
Secondary	Muscle Blood Flow	Forearm blood flow will be assessed by venous occlusion plethysmography	4 months	No