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
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
First received: May 10, 2007
Last updated: November 19, 2008
Last verified: May 2007
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:

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.


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

Inclusion Criteria:

  • CRT Device

Exclusion Criteria:

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

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
Principal Investigator: Dirk Müller, MD, PhD Charité, Campus Benjamin Franklin
Principal Investigator: Fernando C Dimeo, MD, PhD Charité, Campus Benjamin Franklin
  More Information

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
Death, Sudden, Cardiac
Cardiovascular Diseases
Death, Sudden
Heart Arrest
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 22, 2016