Heart FailurePhase 4READNCT00877318
Cardiac Rehabilitation of Heart Failure Patients by Telemedicine
A Phase 4 study testing SCAD information system in people with Heart Failure, run by University Hospital, Caen at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- SCAD information system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 2 sitesFrance
- Study dates
- Mar 2009to Dec 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with a dysfunction of left ventricle with ejection fraction of left ventricle < 40 % appreciated by echocardiogram at hospital discharge for cardiac rehabilitation.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre Hospitalier de la Côte Fleurie
Cricquebœuf, 14113
William Harvey Center
Saint-Martin-d'Aubigny
About this study
Official title: Cardiac Rehabilitation of Heart Failure Patients by Telemedicine: a Randomized Multicenter Study.
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.
- Conditions
- Heart Failure
- Being tested
- SCAD information system
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCAD information systemDevice
Cardiac rehabilitation at home by telemedicine
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: SCAD information system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of VO2 peak at 3 months in comparison to VO2 peak at hospital discharge
Measured: 3 months
Secondary outcomes (13)
VO2 peak at 3 months compared with VO2 peak at the beginning of the hospitalization
Measured: 3 months
BNP
Measured: 3 months
% patient with a BNP < 300 pg/ml
Measured: 3 months
Medical treatment by ACE inhibitor (in % of target dose)
Measured: 3 months
Ejection fraction of left ventricle
Measured: 3 months
Disease knowledge questionnaire
Measured: 3 months
Life quality questionnaire (Minnesota)
Measured: 3 months
Beck questionnaire
Measured: 3 months
Day number at hospital
Measured: 3 months
Number of medical consultation
Measured: 3 months
Pharmaco-economic analysis
Measured: 3 months
Total mortality
Measured: 3 months
Cardiovascular mortality
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2009 (estimated)
- Study startMar 2009
- Primary completionDec 2012
- Study completionDec 2012
Why it stopped: insufficient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Annette Belin, MD, Principal investigator, University Hospital, CaenRémi Sabatier, MD, Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00877318
- Sponsor's protocol ID
- B80908-20
- Acronym
- READ
- Status last verified
- Mar 2016
- First submitted
- 6 Apr 2009
- Last updated
- 18 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Rehabilitation of Heart Failure Patients by Telemedicine: a Randomized Multicenter Study.
- ClinicalTrials.gov ID
- NCT00877318
- Acronym / sponsor ID
- READ / B80908-20
- Conditions
- Heart Failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient recruitment
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 7 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Program of cardiac rehabilitation introduced in complete hospitalization pursued in day hospital during 3 months |
| telemedicine | Experimental | Device: SCAD information systemProgram of cardiac rehabilitation introduced in complete hospitalization pursued at home via a terminal during 3 months |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient with a dysfunction of left ventricle with ejection fraction of left ventricle < 40 % appreciated by echocardiogram at hospital discharge for cardiac rehabilitation.
Key exclusion criteria (6 listed)
- Patient non authorized to follow an effort training
- Therapeutic education impossible
- Pregnant woman or breast-feeding
- No assent
- Incapacity to use the terminal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCAD information systemCardiac rehabilitation at home by telemedicine | Device | telemedicine |
Primary outcome
Variation of VO2 peak at 3 months in comparison to VO2 peak at hospital discharge
Time frame: 3 months
13 secondary outcomes
VO2 peak at 3 months compared with VO2 peak at the beginning of the hospitalization
Time frame: 3 months
BNP
Time frame: 3 months
% patient with a BNP < 300 pg/ml
Time frame: 3 months
Medical treatment by ACE inhibitor (in % of target dose)
Time frame: 3 months
Ejection fraction of left ventricle
Time frame: 3 months
Disease knowledge questionnaire
Time frame: 3 months
Life quality questionnaire (Minnesota)
Time frame: 3 months
Beck questionnaire
Time frame: 3 months
Day number at hospital
Time frame: 3 months
Number of medical consultation
Time frame: 3 months
Pharmaco-economic analysis
Time frame: 3 months
Total mortality
Time frame: 3 months
Cardiovascular mortality
Time frame: 3 months
Results and safety
The study was stopped early (reason given: insufficient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annette Belin, MD principal investigator
University Hospital, Caen
Rémi Sabatier, MD principal investigator
University Hospital, Caen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing SCAD information system in people with Heart Failure, run by University Hospital, Caen at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: insufficient recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation of VO2 peak at 3 months in comparison to VO2 peak at hospital discharge (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2016.