- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Jérôme CORRE, Dr
- Número de teléfono: +262 262 90 05 52
- Correo electrónico: jerome.corre@chu-reunion.fr
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Cardiology patients
Patients aged 55 or older admitted to a cardiology unit for any reason
|
Questionnaire for the Early Detection of Heart Failure
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Estimating the discriminant validity of a tool for detecting decompensated heart failure
Periodo de tiempo: "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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Describe the operational phases involved in developing the screening tool.
Periodo de tiempo: 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.
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2026/RUN/0004
- 2026-A00499-42 (Otro identificador: ID-RCB)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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