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

October 24, 2016 updated by: Thaís Simões Nobre Pires Santos, University of Sao Paulo General Hospital
The investigators hypothesis that exercise training would potentiate the effects of cardiac resynchronization therapy in heart failure patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 05403-000
        • Thais Simoes Nobre Pires Santos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Healthy People
Control group
Experimental: Untrained CRT
Untrained CRT patients
Other: exercise training and/or CRT
Three 40-minute exercise sessions per week on a treadmill for four months
Other Names:
  • Untrained CRT patients
  • Exercise-trained CRT patients
Experimental: Exercise trained + CRT
Exercise-trained CRT patients
Other: exercise training and/or CRT
Three 40-minute exercise sessions per week on a treadmill for four months
Other Names:
  • Untrained CRT patients
  • Exercise-trained CRT patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sympathetic nerve activity
Time Frame: 4 months
Sympathetic nerve activity will be assessed by microneurography
4 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico

Investigators

  • Principal Investigator: Carlos E Negrao, Phd, InCor, HCFMUSP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

March 27, 2013

First Submitted That Met QC Criteria

September 5, 2013

First Posted (Estimate)

September 11, 2013

Study Record Updates

Last Update Posted (Estimate)

October 25, 2016

Last Update Submitted That Met QC Criteria

October 24, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PT & CRT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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