NCT03905226

Brief Summary

Heart failure is a chronic disease whose prevalence, due to the aging of the population, is increasing. In France, the prevalence of this pathology is 2.3% (it reaches 10% in the over 75 years) and affects nearly a million patients. The rehospitalization of patients with heart failure affects 25% of patients within 1-3 months of hospital discharge, and 66% at 1 year while 75% of hospitalizations are preventable. These readmissions result in decreased quality of life and increased mortality; from an economic point of view, hospitalization accounts for 70% of expenses related to the management of heart failure. Avoiding rehospitalization is therefore a major public health issue. The current predictive scores remain perfectible, even though risk factors for readmission have already been the subject of numerous studies. The identification of patients at risk of rehospitalization is still an issue, especially for patients with preserved left ventricular ejection fraction. Targeting patients requiring appropriate care remains an issue. The rise of innovative statistical techniques around Big Data in health opens new perspectives for the scientific exploitation of data available in electronic medical records, for example in the field of prediction. This study aims to explore the risk of rehospitalization in heart failure patients by analyzing routine data collected in medical records and by mobilizing artificial intelligence algorithms. A review of the literature confirms the innovative nature of such an approach: the majority of the studies identified implemented a prospective collection of data; only 20% of the studies mobilized the medical file; no French study used the new machine learning algorithms.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,486

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

January 12, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 5, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

April 27, 2023

Status Verified

April 1, 2023

Enrollment Period

12 months

First QC Date

April 4, 2019

Last Update Submit

April 26, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • Number of readmissions

    Comparison of the number of readmissions predicted to the number actually observed with calculation of the sensitivity and specificity of the model at the validation phase.

    month 1

  • Number of readmissions

    Comparison of the number of readmissions predicted to the number actually observed with calculation of the sensitivity and specificity of the model at the validation phase.

    Month 6

  • Number of readmissions

    Comparison of the number of readmissions predicted to the number actually observed with calculation of the sensitivity and specificity of the model at the validation phase.

    Year 1

Study Arms (1)

Heart Failure

Patients whom initiated a hospital pathway for heart failure management within the Paris Saint Joseph Hospital Group (GHPSJ) between January 1, 2015 and December 31, 2018.

Eligibility Criteria

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

Patients with heart failure hospitalized in the cardiology department ath GHPSJ between january 2015 to december 2018

You may qualify if:

  • Patients older than 18 years
  • Patients with heart failure hospitalized in the cardiology department ath GHPSJ between january 2015 to december 2018

You may not qualify if:

  • Patient opposing the use of his data for this research
  • Patient under tutorship or curatorship
  • Patient deprived of liberty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier Paris Saint-Joseph

Paris, 75014, France

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Philippe ABASSADE, MD

    Fondation Hôpital Saint-Joseph

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 4, 2019

First Posted

April 5, 2019

Study Start

January 12, 2019

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

April 27, 2023

Record last verified: 2023-04

Locations