Back to resultsEffects of Endurance Training on Patients With Reduced Left Ventricular Ejection Fraction (LVEF) and Cardiac Resynchronisation Therapy Especially for Cardiac Arrhythmias
Primary Purpose
Heart Failure, Cardiac Resynchronisation Therapy, Sudden Cardiac Death
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
endurance training
exercise training
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
Eligibility Criteria
Inclusion Criteria:
- CRT Device
Exclusion Criteria:
- refused informed consent
Sites / Locations
- Charité campus Benjamin FranklinRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1, Training
2, Control
Arm Description
Group for training therapy
Outcomes
Primary Outcome Measures
left ventricular function
aerobic threshold
Secondary Outcome Measures
quality of life
Full Information
NCT ID
NCT00472238
First Posted
May 10, 2007
Last Updated
November 19, 2008
Sponsor
Charite University, Berlin, Germany
1. Study Identification
Unique Protocol Identification Number
NCT00472238
Brief Title
Effects of Endurance Training on Patients With Reduced Left Ventricular Ejection Fraction (LVEF) and Cardiac Resynchronisation Therapy Especially for Cardiac Arrhythmias
Official Title
Effects of Endurance Training on Patients With Reduced LVEF and Cardiac Resynchronisation Therapy Especially for Cardiac Arrhythmias
Study Type
Interventional
2. Study Status
Record Verification Date
May 2007
Overall Recruitment Status
Unknown status
Study Start Date
August 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Charite University, Berlin, Germany
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A severely reduced left ventricular ejection fraction is associated with increased mortality due to pump failure as well as to malignant ventricular arrhythmia. We hypothesize that targeted training may lead to improved survival and to increased parameters of risk stratification for malignant arrhythmia. Additionally, the training may lead to an improved psychological and mental condition of the patients
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Cardiac Resynchronisation Therapy, Sudden Cardiac Death
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1, Training
Arm Type
Experimental
Arm Description
Group for training therapy
Arm Title
2, Control
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
endurance training
Intervention Description
control group.
Intervention Type
Behavioral
Intervention Name(s)
exercise training
Intervention Description
Treadmill exercise training to optimize physical endurance
Primary Outcome Measure Information:
Title
left ventricular function
Time Frame
3 months
Title
aerobic threshold
Time Frame
3 months
Secondary Outcome Measure Information:
Title
quality of life
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
CRT Device
Exclusion Criteria:
refused informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dirk Müller, MD, PhD
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fernando C Dimeo, MD, PhD
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charité campus Benjamin Franklin
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dirk Müller, MD, PhD
Phone
+49 39 8445
Ext
3554
Email
dr.dirk.mueller@charite.de
First Name & Middle Initial & Last Name & Degree
Fernando C Dimeo, MD, PhD
Phone
+49 30 8445
Ext
2098
Email
fernando.dimeo@charite.de
First Name & Middle Initial & Last Name & Degree
Dirk Müller, MD, PhD
First Name & Middle Initial & Last Name & Degree
Fernando C Dimeo, MD, PhD
12. IPD Sharing Statement
Learn more about this trial
Effects of Endurance Training on Patients With Reduced Left Ventricular Ejection Fraction (LVEF) and Cardiac Resynchronisation Therapy Especially for Cardiac Arrhythmias
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