Cardiac Rehabilitation of Heart Failure Patients by Telemedicine

Heart Failure Clinical Trial

— READ  

Official title:

Cardiac Rehabilitation of Heart Failure Patients by Telemedicine: a Randomized Multicenter Study.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00877318
• Other study ID #: B80908-20
• Status: Terminated
• Phase: Phase 4
• First received: April 6, 2009
• Last updated: March 17, 2016
• Start date: March 2009
• Est. completion date: December 2012

Study information

• Verified date: March 2016
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 64
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• SCAD information system
Cardiac rehabilitation at home by telemedicine

Locations

Country	Name	City	State
France	Centre Hospitalier de la Côte Fleurie	Cricqueboeuf
France	William Harvey Center	Saint Martin d'Aubigny

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variation of VO2 peak at 3 months in comparison to VO2 peak at hospital discharge		3 months	No
Secondary	VO2 peak at 3 months compared with VO2 peak at the beginning of the hospitalization		3 months	No
Secondary	BNP		3 months	No
Secondary	% patient with a BNP < 300 pg/ml		3 months	No
Secondary	Medical treatment by ACE inhibitor (in % of target dose)		3 months	No
Secondary	Ejection fraction of left ventricle		3 months	No
Secondary	Disease knowledge questionnaire		3 months	No
Secondary	Life quality questionnaire (Minnesota)		3 months	No
Secondary	Beck questionnaire		3 months	No
Secondary	Day number at hospital		3 months	No
Secondary	Number of medical consultation		3 months	No
Secondary	Pharmaco-economic analysis		3 months	No
Secondary	Total mortality		3 months	No
Secondary	Cardiovascular mortality		3 months	No