- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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) (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)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Jérôme CORRE, Dr
- Telefonnummer: +262 262 90 05 52
- E-mail: jerome.corre@chu-reunion.fr
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Cardiology patients
Patients aged 55 or older admitted to a cardiology unit for any reason
|
Questionnaire for the Early Detection of Heart Failure
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Estimating the discriminant validity of a tool for detecting decompensated heart failure
Tidsramme: "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. |
"From enrollment to the end of the study, at 6 month
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Describe the operational phases involved in developing the screening tool.
Tidsramme: 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.
|
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.
Tidsramme: 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).
|
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
Tidsramme: 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
|
From enrollment to the end of the study at 6 month
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2026/RUN/0004
- 2026-A00499-42 (Anden identifikator: ID-RCB)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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