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Effects of Endurance Training on Patients With Reduced Left Ventricular Ejection Fraction (LVEF) and Cardiac Resynchronisation Therapy Especially for Cardiac Arrhythmias

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2007 by Charite University, Berlin, Germany.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00472238
First received: May 10, 2007
Last updated: November 19, 2008
Last verified: May 2007
History of Changes
  Purpose

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


Condition Intervention
Heart Failure
Cardiac Resynchronisation Therapy
Sudden Cardiac Death
 Behavioral: endurance training
Behavioral: exercise training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Endurance Training on Patients With Reduced LVEF and Cardiac Resynchronisation Therapy Especially for Cardiac Arrhythmias

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • left ventricular function [ Time Frame: 3 months ]
  • aerobic threshold [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • quality of life [ Time Frame: 3 months ]

Estimated Enrollment: 30
Study Start Date: August 2007
Estimated Study Completion Date: December 2008
Arms Assigned Interventions
Experimental: 1, Training
Group for training therapy
 Behavioral: exercise training
Treadmill exercise training to optimize physical endurance
Active Comparator: 2, Control Behavioral: endurance training
control group.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • CRT Device

Exclusion Criteria:

  • refused informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00472238

Locations
Germany
Charité campus Benjamin Franklin Recruiting
Berlin, Germany, 12200
Contact: Dirk Müller, MD, PhD     +49 39 8445 ext 3554     dr.dirk.mueller@charite.de    
Contact: Fernando C Dimeo, MD, PhD     +49 30 8445 ext 2098     fernando.dimeo@charite.de    
Principal Investigator: Dirk Müller, MD, PhD            
Principal Investigator: Fernando C Dimeo, MD, PhD            
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Principal Investigator: Dirk Müller, MD, PhD Charité, Campus Benjamin Franklin
Principal Investigator: Fernando C Dimeo, MD, PhD Charité, Campus Benjamin Franklin
  More Information

No publications provided

Responsible Party: Dr. Dirk Müller, Charité Campus Benjamin Franklin
ClinicalTrials.gov Identifier: NCT00472238     History of Changes
Other Study ID Numbers: CBF-2007001, 001
Study First Received: May 10, 2007
Last Updated: November 19, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Failure
Death, Sudden, Cardiac
Death
Heart Diseases
 Cardiovascular Diseases
Pathologic Processes
Heart Arrest
Death, Sudden

ClinicalTrials.gov processed this record on May 22, 2013