Actively Recruiting
Acute Heart Failure With Preserved Ejection Fraction - COngestion Discharge Evaluation: Evaluation de la Congestion à la Sortie d'Hospitalisation Pour Insuffisance Cardiaque aiguë à Fraction d'éjection préservée
Led by Central Hospital, Nancy, France · Updated on 2023-06-05
170
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients with acute heart failure who have a preserved ejection fraction and are hospitalized due to worsening heart failure. The study aims to identify specific markers of congestion—clinical signs, biological factors, and ultrasound findings—at the time of hospital discharge that are linked to the risk of death or rehospitalization within three months after leaving the hospital. Patients will undergo several evaluations before leaving the hospital, including a clinical exam focused on congestion, multiple types of Doppler ultrasounds (cardiopulmonary, peritoneal, jugular, and renal), liver elastography, and blood sample collection for biological tests and biobanking. After discharge, participants will have telephone interviews and complete quality of life questionnaires at 3, 12, and 24 months. During the study, researchers will track rates of death from any cause, rehospitalization for acute heart failure, and intravenous diuretic treatments given in day hospitals or at home at 3, 12, and 24 months after discharge. They will also assess heart function symptoms, kidney function, natriuretic peptides, plasma volume, blood potassium levels, liver measurements, and quality of life. The study includes safety follow-up through telephone interviews and questionnaires over two years.
CONDITIONS
Brief Title
Acute Heart Failure With Preserved Ejection Fraction - COngestion Discharge Evaluation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients hospitalized for acute heart failure
- Preserved ejection fraction (FE 250%)
- Patients ready for discharge from hospital for acute heart failure
- Age 18 years or older
- Provided informed consent after receiving complete study information
- Affiliated with or beneficiary of a social security scheme
You will not qualify if you...
- Life expectancy of 3 months or less due to other conditions
- Patients on peritoneal or hemodialysis or with glomerular filtration rate under 15 ml/min/m
- History of lung surgery such as lobectomy or pneumonectomy
- Severe lung or pleural disease preventing lung ultrasound (e.g., emphysema, chronic pleurisy, pulmonary fibrosis)
- Pregnant, giving birth, or nursing women
- Adults under legal protection measures (guardianship, curatorship, safeguard of justice)
- Adults unable to give consent
- Persons deprived of liberty by judicial or administrative decision
- Persons receiving psychiatric care under specified public health codes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to hospital discharge
Participants undergo clinical examinations centered on congestion, various Doppler ultrasounds, liver elastography, and blood sample collection before hospital discharge.
1 visit (in-person) before discharge
Duration - 24 months after hospital discharge
Participants complete telephone interviews and quality of life questionnaires to monitor health status and outcomes after hospital discharge.
Telephone interviews and questionnaires at 3, 12, and 24 months after discharge
Trial Site Locations
Total: 1 location
1
CHRU de Nancy
Vandœuvre-lès-Nancy, France, 54500
Actively Recruiting
Research Team
N
Nicolas GIRERD, MD,PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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