Actively Recruiting
Evaluation of Congestion in Day Hospitalization for Chronic Heart Failure with Reduced or Moderately Reduced Left Ventricular Ejection Fraction CHF-COV Reduced (Chronic Heart Failure With Reduced Ejection Fraction - COngestion eValuation)
Led by Pr. Nicolas GIRERD · Updated on 2023-06-05
200
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Chronic heart failure (HF) with reduced ventricular ejection fraction is a serious condition leading to high rates of death and hospitalization, particularly in older adults. Congestion is a key cause of symptoms and hospital stays in HF patients, and early signs of congestion in symptom-free patients can indicate risk for developing symptomatic HF. Researchers are studying various congestion markers, including clinical, biological, and ultrasound measures, to better predict outcomes such as death, hospitalizations, and intravenous diuretic treatments in patients with chronic HF and reduced ejection fraction. Participants in this study undergo a comprehensive evaluation during a scheduled day hospitalization or consultation. This includes a clinical examination focused on congestion using specific scoring systems, multiple Doppler ultrasounds of the heart, lungs, peritoneum, jugular vein, and kidneys, as well as liver elastography. Blood samples are collected for biological tests and biobanking. Some ultrasounds are optional. Participants complete quality of life questionnaires at discharge and at 3, 12, and 24 months. Telephone follow-ups also occur at these time points. Throughout the study, participants are monitored for outcomes such as all-cause death, hospitalizations for acute heart failure, and intravenous diuretics use over 24 months after their hospitalization or consultation. Additional assessments include blood tests for heart and kidney function and repeated quality of life measures. This approach aims to identify important congestion markers associated with worsening heart failure and related complications. The study lasts over two years with evaluations at multiple intervals to track participants' health and quality of life.
CONDITIONS
Brief Title
CHF-COV Reduced (Chronic Heart Failure With Reduced Ejection Fraction - COngestion eValuation)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with chronic acute heart failure with reduced ventricular ejection fraction admitted for scheduled day hospitalization or consultation
- Left ventricular ejection fraction less than 40% or between 40% and 50%
- Age 18 years or older
- Patients who have received complete information about the study and signed informed consent
- Patients affiliated with or beneficiaries of a social security scheme
You will not qualify if you...
- Comorbid condition with life expectancy 3 months or less
- Dialysis patients or those with glomerular filtration rate less than 15 ml/min/m2
- History of lung surgery such as lobectomy or pneumonectomy
- Severe lung or pleural diseases preventing reliable lung ultrasound (e.g., severe emphysema, chronic pleurisy, pulmonary fibrosis)
- Pregnant women, women who have recently given birth, or nursing mothers
- Adults under legal protection measures (guardianship, curatorship, safeguard of justice)
- Adults unable to give informed consent
- Persons deprived of liberty by judicial or administrative decision
- Persons under psychiatric care according to public health code articles L. 3212-1 and L. 3213-1
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day hospitalization or consultation day
Participants undergo clinical examinations centered on congestion, including Doppler ultrasounds and blood sample collection during day hospitalization or consultation.
1 visit (in-person)
Duration - 24 months after day hospitalization or consultation
Participants complete quality of life questionnaires and receive telephone follow-up to assess health status over time.
Telephone follow-up at 3, 12, and 24 months; questionnaires at discharge and 3, 6, 12, and 24 months
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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