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NCT Number: NCT07673562

The Value of a Simple Tool for the Early Detection of Decompensated Heart Failure in People Over 55 on Réunion Island: A Preliminary Study in Hospitals (DEPIST'IC-RUN)

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)

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Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

This is a preliminary, cross-sectional "diagnostic" ("screening") study (to assess validity relative to the gold standard test), conducted at two centers, evaluating a questionnaire that does not alter the patient's standard of care (prospective data collection).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Early Detection Questionnaire

Diagnostic Test

Questionnaire for the Early Detection of Heart Failure

Primary outcomes

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

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

    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.

Secondary outcomes

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

    Time frame: From enrolment to the end of the study, at 6 month

    The detailed description of the tool's development phase is a task that complements statistical modeling (of the tool's development) and is purely epidemiological in nature.

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

    Time frame: From enrollment to the end of the study at 6 months

    The following characteristics are collected: age, sex, socioeconomic status, residential area (north, south, west, east); cardiovascular risk factors (hypertension, diabetes, dyslipidemia, known heart disease, history of myocardial infarction, end-stage renal disease requiring dialysis); lifestyle factors (Body Mass Index (kg/m²), physical activity > 30 min at least 3 times/week, current smoking, alcohol consumption > 3 drinks/day).

  3. 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

    Time frame: From enrollment to the end of the study at 6 month

    Socio-demographic data (age, sex, residential area) and clinical data (cardiovascular history) for the population with heart failure in Réunion, obtained from the SNDS, will be compared with those of the sample in this study

Study contacts

Contact information is provided by the study sponsor or research team.

Jérôme CORRE, Dr

CONTACT

[email protected]

+262 262 90 05 52

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de la Réunion

Other

Registry information

Acronym: DEPIST'IC-RUN

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 29, 2026
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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