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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

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ClinicalTrials.gov Identifier: NCT00472238
Recruitment Status : Unknown
Verified May 2007 by Charite University, Berlin, Germany.
Recruitment status was:  Recruiting
First Posted : May 11, 2007
Last Update Posted : November 20, 2008
Sponsor:
Information provided by:

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

Condition or disease Intervention/treatment
Heart Failure Cardiac Resynchronisation Therapy Sudden Cardiac Death Behavioral: endurance training Behavioral: exercise training

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Endurance Training on Patients With Reduced LVEF and Cardiac Resynchronisation Therapy Especially for Cardiac Arrhythmias
Study Start Date : August 2007
Estimated Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arrhythmia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. left ventricular function [ Time Frame: 3 months ]
  2. aerobic threshold [ Time Frame: 3 months ]

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • CRT Device

Exclusion Criteria:

  • refused informed consent
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Charite University, Berlin, Germany
Principal Investigator: Fernando C Dimeo, MD, PhD Charite University, Berlin, Germany
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
First Posted: May 11, 2007    Key Record Dates
Last Update Posted: November 20, 2008
Last Verified: May 2007

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