NCT00877318

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
64

participants targeted

Target at P25-P50 for phase_4 heart-failure

Timeline
Completed

Started Mar 2009

Typical duration for phase_4 heart-failure

Geographic Reach
1 country

2 active sites

Status
terminated

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

Study Start

First participant enrolled

March 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 6, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 7, 2009

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

March 18, 2016

Status Verified

March 1, 2016

Enrollment Period

3.8 years

First QC Date

April 6, 2009

Last Update Submit

March 17, 2016

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • Variation of VO2 peak at 3 months in comparison to VO2 peak at hospital discharge

    3 months

Secondary Outcomes (13)

  • VO2 peak at 3 months compared with VO2 peak at the beginning of the hospitalization

    3 months

  • BNP

    3 months

  • % patient with a BNP < 300 pg/ml

    3 months

  • Medical treatment by ACE inhibitor (in % of target dose)

    3 months

  • Ejection fraction of left ventricle

    3 months

  • +8 more secondary outcomes

Study Arms (2)

Control

NO INTERVENTION

Program of cardiac rehabilitation introduced in complete hospitalization pursued in day hospital during 3 months

telemedicine

EXPERIMENTAL

Program of cardiac rehabilitation introduced in complete hospitalization pursued at home via a terminal during 3 months

Device: SCAD information system

Interventions

SCAD information systemDEVICE

Cardiac rehabilitation at home by telemedicine

telemedicine

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre Hospitalier de la Côte Fleurie

Cricquebœuf, 14113, France

Location

William Harvey Center

Saint-Martin-d'Aubigny, France

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Annette Belin, MD

    University Hospital, Caen

    PRINCIPAL INVESTIGATOR

  • Rémi Sabatier, MD

    University Hospital, Caen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2009

First Posted

April 7, 2009

Study Start

March 1, 2009

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

March 18, 2016

Record last verified: 2016-03

Locations

FR(2)