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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)

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Detaljert beskrivelse

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).

Studietype

Observasjonsmessig

Registrering (Antatt)

300

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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)

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Cardiology patients
Patients aged 55 or older admitted to a cardiology unit for any reason
Questionnaire for the Early Detection of Heart Failure

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

12. august 2026

Primær fullføring (Antatt)

1. februar 2027

Studiet fullført (Antatt)

1. februar 2027

Datoer for studieregistrering

Først innsendt

18. juni 2026

Først innsendt som oppfylte QC-kriteriene

23. juni 2026

Først lagt ut (Faktiske)

29. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

29. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

23. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2026/RUN/0004
  • 2026-A00499-42 (Annen identifikator: ID-RCB)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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