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

Heart Failure Clinical Trial

Official title:

Effects of Endurance Training on Patients With Reduced LVEF and Cardiac Resynchronisation Therapy Especially for Cardiac Arrhythmias

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00472238
• Other study ID #: CBF-2007001
• Secondary ID: 001
• Status: Recruiting
• Phase: N/A
• First received: May 10, 2007
• Last updated: November 19, 2008
• Start date: August 2007
• Est. completion date: December 2008

Study information

• Verified date: May 2007
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• CRT Device

Exclusion Criteria:

• refused informed consent

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Resynchronisation Therapy
• Death, Sudden, Cardiac
• Heart Failure
• Sudden Cardiac Death

Intervention

Behavioral:
• endurance training
control group.
• exercise training
Treadmill exercise training to optimize physical endurance

Locations

Country	Name	City	State
Germany	Charité campus Benjamin Franklin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	left ventricular function		3 months
Primary	aerobic threshold		3 months
Secondary	quality of life		3 months