Chronic Heart FailurePREDICNCT04984928
Readmission Risk of Patients With Heart Failure.
An observational study of Chronic Heart Failure, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Heart failure (HF) is a frequent, serious, and costly chronic disease: it leads to 150,000 hospitalizations each year in France at a cost of 525 million Euros. It is estimated that 20-40% of these hospitalizations are preventable by known interventions: home telemonitoring, care coordination, therapeutic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Heart Failure
- How many people
- 1,500 participants
- Where
- 1 siteFrance
- Study dates
- 20 Sep 2021to 30 Dec 2022
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Heart failure patients
Who may be able to join
- All consecutive adults
- Admitted to Montpellier University Hospital in 2017-2020
- For heart failure
Who cannot join
- age < 18 years
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Uh Montpellier
Montpellier, 34295
Grégoire MERCIER, PUPH, 4 67 33 91 09 ext. 33, g-mercier@chu-montpellier.fr
About this study
Official title: Predicting the Risk of Readmission in Patients With Chronic Heart Failure
Heart failure (HF) is a frequent, serious, and costly chronic disease: it leads to 150,000 hospitalizations each year in France at a cost of 525 million Euros.
It is estimated that 20-40% of these hospitalizations are preventable by known interventions: home telemonitoring, care coordination, therapeutic intensification and therapeutic education. But these interventions only work if patients at high risk of rehospitalization are targeted to individualize management. In these patients, the risk of rehospitalization depends on clinical, biological, socioeconomic, care pathway, and location-related data. Existing predictive tools perform poorly due to three important limitations: non-use of unstructured clinical data, lack of integration of multimodal data, and weakness of the algorithmic approach.
The objective is to design and validate a predictive algorithm for the risk of rehospitalization in heart failure patients, using multiple data sources
- Conditions
- Chronic Heart Failure
- Keywords
- Heart failure, Prediction, Personnalized medicine
- Medical subject headings
- Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
30 days all cause readmission rate
30 days all cause readmission rate
Measured: day 30
Secondary outcomes (1)
90 days all cause readmission rate
90 days all cause readmission rate
Measured: day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study start20 Sep 2021
- Primary completion1 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Grégoire Mercier, PU PH, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04984928
- Sponsor's protocol ID
- RECHMPL21_0488
- Acronym
- PREDIC
- Status last verified
- Apr 2022
- First submitted
- 19 Jul 2021
- Last updated
- 12 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting the Risk of Readmission in Patients With Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT04984928
- Acronym / sponsor ID
- PREDIC / RECHMPL21_0488
- Conditions
- Chronic Heart Failure
- Keywords
- Heart failure, Prediction, Personnalized medicine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 20 Sep 2021 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 2 Aug 2021 (actual)
- 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.
Heart failure (HF) is a frequent, serious, and costly chronic disease: it leads to 150,000 hospitalizations each year in France at a cost of 525 million Euros.
It is estimated that 20-40% of these hospitalizations are preventable by known interventions: home telemonitoring, care coordination, therapeutic intensification and therapeutic education. But these interventions only work if patients at high risk of rehospitalization are targeted to individualize management. In these patients, the risk of rehospitalization depends on clinical, biological, socioeconomic, care pathway, and location-related data. Existing predictive tools perform poorly due to three important limitations: non-use of unstructured clinical data, lack of integration of multimodal data, and weakness of the algorithmic approach.
The objective is to design and validate a predictive algorithm for the risk of rehospitalization in heart failure patients, using multiple data sources
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Heart failure patients
Key inclusion criteria (3 listed)
- All consecutive adults
- Admitted to Montpellier University Hospital in 2017-2020
- For heart failure
Key exclusion criteria (1 listed)
- age < 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
30 days all cause readmission rate
Time frame: day 30
30 days all cause readmission rate
1 secondary outcome
90 days all cause readmission rate
Time frame: day 90
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
- Individual participant dataSharing planned: Undecided. NC
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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.
Grégoire Mercier, PU PH principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Heart Failure, run by University Hospital, Montpellier at 1 site 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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Grégoire Mercier, PU PH (4 67 33 91 09 ext. 33, g-mercier@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30 days all cause readmission rate (time frame: day 30). 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 12 Apr 2022; AzTrials last refreshed its copy on 7 Nov 2026.