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Cardiac Rehabilitation of Heart Failure Patients by Telemedicine (READ)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00877318
Recruitment Status : Terminated (insufficient recruitment)
First Posted : April 7, 2009
Last Update Posted : March 18, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen

Brief Summary:
The purpose of the READ study is to compare the continuation of the cardiac rehabilitation at home with clinical follow-up, therapeutic education, and advice on the training at the stamina, via telemedicine with the classic strategy in day hospital.

Condition or disease Intervention/treatment Phase
Heart Failure Device: SCAD information system Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cardiac Rehabilitation of Heart Failure Patients by Telemedicine: a Randomized Multicenter Study.
Study Start Date : March 2009
Primary Completion Date : December 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: Control
Program of cardiac rehabilitation introduced in complete hospitalization pursued in day hospital during 3 months
Experimental: telemedicine
Program of cardiac rehabilitation introduced in complete hospitalization pursued at home via a terminal during 3 months
Device: SCAD information system
Cardiac rehabilitation at home by telemedicine



Primary Outcome Measures :
  1. Variation of VO2 peak at 3 months in comparison to VO2 peak at hospital discharge [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. VO2 peak at 3 months compared with VO2 peak at the beginning of the hospitalization [ Time Frame: 3 months ]
  2. BNP [ Time Frame: 3 months ]
  3. % patient with a BNP < 300 pg/ml [ Time Frame: 3 months ]
  4. Medical treatment by ACE inhibitor (in % of target dose) [ Time Frame: 3 months ]
  5. Ejection fraction of left ventricle [ Time Frame: 3 months ]
  6. Disease knowledge questionnaire [ Time Frame: 3 months ]
  7. Life quality questionnaire (Minnesota) [ Time Frame: 3 months ]
  8. Beck questionnaire [ Time Frame: 3 months ]
  9. Day number at hospital [ Time Frame: 3 months ]
  10. Number of medical consultation [ Time Frame: 3 months ]
  11. Pharmaco-economic analysis [ Time Frame: 3 months ]
  12. Total mortality [ Time Frame: 3 months ]
  13. Cardiovascular mortality [ Time Frame: 3 months ]


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:

  • Patient with a dysfunction of left ventricle with ejection fraction of left ventricle < 40 % appreciated by echocardiogram at hospital discharge for cardiac rehabilitation.

Exclusion Criteria:

  • Patient non authorized to follow an effort training
  • Therapeutic education impossible
  • Pregnant woman or breast-feeding
  • No assent
  • Incapacity to use the terminal
  • Minor patient or under supervision

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): NCT00877318


Locations
France
Centre Hospitalier de la Côte Fleurie
Cricqueboeuf, France, 14113
William Harvey Center
Saint Martin d'Aubigny, France
Sponsors and Collaborators
University Hospital, Caen
Investigators
Principal Investigator: Annette Belin, MD University Hospital, Caen
Principal Investigator: Rémi Sabatier, MD University Hospital, Caen

Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT00877318     History of Changes
Other Study ID Numbers: B80908-20
First Posted: April 7, 2009    Key Record Dates
Last Update Posted: March 18, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases