NCT04984928

Brief 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 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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

July 19, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 2, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

September 20, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

April 12, 2022

Status Verified

April 1, 2022

Enrollment Period

1.2 years

First QC Date

July 19, 2021

Last Update Submit

April 11, 2022

Conditions

Chronic Heart Failure

Keywords

Heart failurePredictionPersonnalized medicine

Outcome Measures

Primary Outcomes (1)

  • 30 days all cause readmission rate

    30 days all cause readmission rate

    day 30

Secondary Outcomes (1)

  • 90 days all cause readmission rate

    day 90

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Heart failure patients

You may qualify if:

  • All consecutive adults
  • Admitted to Montpellier University Hospital in 2017-2020
  • For heart failure

You may not qualify if:

  • \- age \< 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uh Montpellier

Montpellier, 34295, France

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Grégoire Mercier, PU PH

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Grégoire Mercier, PU PH

CONTACT

4 67 33 91 09g-mercier@chu-montpellier.fr

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2021

First Posted

August 2, 2021

Study Start

September 20, 2021

Primary Completion

December 1, 2022

Study Completion

December 30, 2022

Last Updated

April 12, 2022

Record last verified: 2022-04

Locations

FR(1)