Back to resultsEffect of Physical Training Combined Cardiac Resynchronization Therapy in Heart Failure Patients
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
exercise training and/or CRT
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring cardiac resynchronization therapy (CRT)
Eligibility 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
Sites / Locations
- Thais Simoes Nobre Pires Santos
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
Healthy People
Untrained CRT
Exercise trained + CRT
Arm Description
Control group
Untrained CRT patients
Exercise-trained CRT patients
Outcomes
Primary Outcome Measures
Sympathetic nerve activity
Sympathetic nerve activity will be assessed by microneurography
Secondary Outcome Measures
Peak oxygen consumption
Peak oxygen consumption will be determined by cardiopulmonary exercise testing
Quality of life
Quality of life will be assessed by questionnaire
Blood inflammatory markers
Blood inflammatory markers will be assessed by venipuncture
skeletal muscle strength
Muscular evaluation will be done muscle gene expression
Muscle Blood Flow
Forearm blood flow will be assessed by venous occlusion plethysmography
Full Information
NCT ID
NCT01939795
First Posted
March 27, 2013
Last Updated
October 24, 2016
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
1. Study Identification
Unique Protocol Identification Number
NCT01939795
Brief Title
Effect of Physical Training Combined Cardiac Resynchronization Therapy in Heart Failure Patients
Official Title
Effect of Physical Training Combined Cardiac Resynchronization Therapy in Heart Failure Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the 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
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators hypothesis that exercise training would potentiate the effects of cardiac resynchronization therapy in heart failure patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
cardiac resynchronization therapy (CRT)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy People
Arm Type
No Intervention
Arm Description
Control group
Arm Title
Untrained CRT
Arm Type
Experimental
Arm Description
Untrained CRT patients
Arm Title
Exercise trained + CRT
Arm Type
Experimental
Arm Description
Exercise-trained CRT patients
Intervention Type
Other
Intervention Name(s)
exercise training and/or CRT
Other Intervention Name(s)
Untrained CRT patients, Exercise-trained CRT patients
Intervention Description
Three 40-minute exercise sessions per week on a treadmill for four months
Primary Outcome Measure Information:
Title
Sympathetic nerve activity
Description
Sympathetic nerve activity will be assessed by microneurography
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Peak oxygen consumption
Description
Peak oxygen consumption will be determined by cardiopulmonary exercise testing
Time Frame
4 months
Title
Quality of life
Description
Quality of life will be assessed by questionnaire
Time Frame
4 months
Title
Blood inflammatory markers
Description
Blood inflammatory markers will be assessed by venipuncture
Time Frame
4 months
Title
skeletal muscle strength
Description
Muscular evaluation will be done muscle gene expression
Time Frame
4 months
Title
Muscle Blood Flow
Description
Forearm blood flow will be assessed by venous occlusion plethysmography
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos E Negrao, Phd
Organizational Affiliation
InCor, HCFMUSP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thais Simoes Nobre Pires Santos
City
São Paulo
State/Province
SP
ZIP/Postal Code
05403-000
Country
Brazil
12. IPD Sharing Statement
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Effect of Physical Training Combined Cardiac Resynchronization Therapy in Heart Failure Patients
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