NCT00472238

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started Aug 2007

Shorter than P25 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 11, 2007

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2007

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

November 20, 2008

Status Verified

May 1, 2007

First QC Date

May 10, 2007

Last Update Submit

November 19, 2008

Conditions

Heart FailureCardiac Resynchronisation TherapySudden Cardiac Death

Outcome Measures

Primary Outcomes (2)

  • left ventricular function

    3 months

  • aerobic threshold

    3 months

Secondary Outcomes (1)

  • quality of life

    3 months

Study Arms (2)

1, Training

EXPERIMENTAL

Group for training therapy

Behavioral: exercise training

2, Control

ACTIVE COMPARATOR
Behavioral: endurance training

Interventions

endurance trainingBEHAVIORAL

control group.

2, Control
exercise trainingBEHAVIORAL

Treadmill exercise training to optimize physical endurance

1, Training

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • CRT Device

You may not qualify if:

  • refused informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité campus Benjamin Franklin

Berlin, State of Berlin, 12200, Germany

RECRUITING

MeSH Terms

Conditions

Heart FailureDeath, Sudden, Cardiac

Interventions

Endurance TrainingExercise

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesHeart ArrestDeath, SuddenDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Dirk Müller, MD, PhD

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

  • Fernando C Dimeo, MD, PhD

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 10, 2007

First Posted

May 11, 2007

Study Start

August 1, 2007

Study Completion

December 1, 2008

Last Updated

November 20, 2008

Record last verified: 2007-05

Locations

DE(1)