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

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ClinicalTrials.gov Identifier: NCT01939795
Recruitment Status : Completed
First Posted : September 11, 2013
Last Update Posted : October 25, 2016
Sponsor:
Collaborators:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
Thaís Simões Nobre Pires Santos, 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.

Condition or disease Intervention/treatment Phase
Heart Failure Other: exercise training and/or CRT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Physical Training Combined Cardiac Resynchronization Therapy in Heart Failure Patients
Study Start Date : January 2009
Actual Primary Completion Date : September 2014
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Sympathetic nerve activity [ Time Frame: 4 months ]
    Sympathetic nerve activity will be assessed by microneurography


Secondary Outcome Measures :
  1. Peak oxygen consumption [ Time Frame: 4 months ]
    Peak oxygen consumption will be determined by cardiopulmonary exercise testing

  2. Quality of life [ Time Frame: 4 months ]
    Quality of life will be assessed by questionnaire

  3. Blood inflammatory markers [ Time Frame: 4 months ]
    Blood inflammatory markers will be assessed by venipuncture

  4. skeletal muscle strength [ Time Frame: 4 months ]
    Muscular evaluation will be done muscle gene expression

  5. Muscle Blood Flow [ Time Frame: 4 months ]
    Forearm blood flow will be assessed by venous occlusion plethysmography



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01939795


Locations
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Brazil
Thais Simoes Nobre Pires Santos
São Paulo, SP, Brazil, 05403-000
Sponsors and Collaborators
University of Sao Paulo General Hospital
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
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Principal Investigator: Carlos E Negrao, Phd InCor, HCFMUSP

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Responsible Party: Thaís Simões Nobre Pires Santos, Phd student, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT01939795     History of Changes
Other Study ID Numbers: PT & CRT
First Posted: September 11, 2013    Key Record Dates
Last Update Posted: October 25, 2016
Last Verified: October 2016

Keywords provided by Thaís Simões Nobre Pires Santos, University of Sao Paulo General Hospital:
cardiac resynchronization therapy (CRT)

Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases