NCT07673562

Brief Summary

The goal of this study is to assess the discriminatory power of a previously developed tool for detecting decompensated heart failure-which includes, in particular, clinical signs-in a population of patients hospitalized in cardiology units in Réunion. The main question it aims to answer is : Would a simple and rapid screening tool for decompensated heart failure help identify a high probability of this condition in a population hospitalized in a cardiology unit in Réunion? This study includes patients aged 55 and older, who reside in Réunion, who were admitted on an unscheduled basis to the cardiology department at the Réunion University Hospital or the Ouest Réunion Hospital, for any reason (whether as an inpatient or in the intensive care unit) The study is conducted in two phases: Phase 1: Development of the new e-DELPHI consensus-based screening tool Phase 2: Administration of the Déspist'IC-Run early detection tool for decompensated heart failure and performance of the gold standard cardiology examination (RIPH3)

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
6mo left

Started Aug 2026

Shorter than P25 for all trials

Status
not yet recruiting

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

June 18, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 29, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

August 12, 2026

Expected
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

June 29, 2026

Status Verified

June 1, 2026

Enrollment Period

6 months

First QC Date

June 18, 2026

Last Update Submit

June 23, 2026

Conditions

Keywords

Decompensated heart failureearly detectionquestionnaire

Outcome Measures

Primary Outcomes (1)

  • Estimating the discriminant validity of a tool for detecting decompensated heart failure

    The probability of having decompensated heart failure, as determined by a screening tool in the form of a questionnaire, will be calculated using the equation of a logistic regression model that explains the observed status (dependent variable) as determined by the gold standard test. The gold standard test for establishing a definitive diagnosis of decompensated heart failure will combine three tests: a clinical examination by a cardiologist, a transthoracic Doppler echocardiogram (TTE), and an electrocardiogram.

    "From enrollment to the end of the study, at 6 month

Secondary Outcomes (3)

  • Describe the operational phases involved in developing the screening tool.

    From enrolment to the end of the study, at 6 month

  • Describe the sociodemographic and clinical characteristics, as well as the lifestyle habits, of the study population.

    From enrollment to the end of the study at 6 months

  • Compare the sociodemographic and medical characteristics of this population of patients hospitalized in cardiology with those of other populations of patients with heart failure seen in private practices-whether in cardiology or general practice

    From enrollment to the end of the study at 6 month

Study Arms (1)

Cardiology patients

Patients aged 55 or older admitted to a cardiology unit for any reason

Diagnostic Test: Early Detection Questionnaire

Interventions

Questionnaire for the Early Detection of Heart Failure

Cardiology patients

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients aged 55 or older who reside on Réunion Island and are hospitalized in the cardiology department of the University Hospital (CHU) or the Centre Hospitalier Ouest Réunion (CHOR)

You may qualify if:

  • Patients:
  • Aged 55 and older
  • Admitted on an unscheduled basis to the cardiology department at the CHU (North and South campuses) and the CHOR for any reason (in general wards or intensive care)
  • Residents of Réunion
  • Able to read and write French
  • Enrolled in a social security program
  • Willing to participate in the study

You may not qualify if:

  • Patients:
  • Who cannot communicate in French
  • For whom it is impossible to administer the questionnaire
  • For whom the ETT and/or cardiology consultation are impossible
  • Who are under guardianship, conservatorship, or judicial protection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

June 18, 2026

First Posted

June 29, 2026

Study Start (Estimated)

August 12, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

June 29, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share