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OpenTrials
Completed

NCT Number: NCT01939795

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

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

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Thais Simoes Nobre Pires Santos

São Paulo, 05403-000, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

exercise training and/or CRT

Other

Three 40-minute exercise sessions per week on a treadmill for four months

Other names: Untrained CRT patients, Exercise-trained CRT patients

Primary outcomes

  1. Sympathetic nerve activity

    Time frame: 4 months

    Sympathetic nerve activity will be assessed by microneurography

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Collaborators

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

Registry information

Important dates

Study start
2009
Primary completion
2014
Study completion
2015
First posted
Sep 11, 2013
Registry last updated
Oct 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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