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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

NCT ID: NCT00472238

Last Updated: 2008-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2008-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Heart Failure Cardiac Resynchronisation Therapy Sudden Cardiac Death

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1, Training

Group for training therapy

Group Type EXPERIMENTAL

exercise training

Intervention Type BEHAVIORAL

Treadmill exercise training to optimize physical endurance

2, Control

Group Type ACTIVE_COMPARATOR

endurance training

Intervention Type BEHAVIORAL

control group.

Interventions

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endurance training

control group.

Intervention Type BEHAVIORAL

exercise training

Treadmill exercise training to optimize physical endurance

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* CRT Device

Exclusion Criteria

* refused informed consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Charité Campus Benjamin Franklin

Principal Investigators

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Dirk Müller, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Fernando C Dimeo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

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Charité campus Benjamin Franklin

Berlin, State of Berlin, Germany

Site Status RECRUITING

Countries

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Germany

Facility Contacts

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Dirk Müller, MD, PhD

Role: primary

Fernando C Dimeo, MD, PhD

Role: backup

Other Identifiers

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001

Identifier Type: -

Identifier Source: secondary_id

CBF-2007001

Identifier Type: -

Identifier Source: org_study_id