Actively Recruiting
Evaluation of Congestion in Outpatients with Chronic Heart Failure CHF-COV Study
Led by Pr. Nicolas GIRERD · Updated on 2023-06-05
200
Participants Needed
2
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating markers of congestion in patients with chronic heart failure (HF), a leading cause of hospitalization and death in older adults. This study aims to identify clinical, biological, and ultrasound markers measured during scheduled consultations or day hospitalizations that are linked to the risk of death or hospitalization due to acute heart failure within 24 months. Understanding these markers could help improve monitoring and management of chronic HF. Participants will undergo a clinical exam focused on congestion, including the use of specific scoring systems, and several types of Doppler ultrasounds of the heart, lungs, peritoneum, jugular and renal veins, along with optional liver elastography. Blood samples will be taken for biological assessments and biobanking. Follow-up will be conducted by telephone at 3, 12, and 24 months after the initial visit. Patients will also complete a quality of life questionnaire at discharge and during follow-ups. During the study, participants will be closely monitored through clinical exams, ultrasounds, laboratory tests, and questionnaires assessing quality of life. The primary outcomes measured are the rates of all-cause death and hospitalization for acute heart failure over 24 months. Secondary outcomes include cardiovascular hospitalizations, death rates, heart function class, various blood markers, renal function, plasma volume, liver status, and patient quality of life. The study ensures ongoing safety monitoring through regular follow-ups and assessments over two years.
CONDITIONS
Brief Title
Chronic Heart Failure - COngestion eValuation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with chronic heart failure admitted for scheduled day hospitalization or consultation
- Age 18 years or older
- Patients who have received complete information and signed informed consent
- Affiliated to or beneficiary of a social security scheme
You will not qualify if you...
- Comorbidity with life expectancy of 3 months or less
- Patients on peritoneal dialysis or hemodialysis, or with glomerular filtration rate below 15 ml/min/m2
- History of lobectomy or pneumonectomy lung surgery
- Severe pulmonary or pleural disease preventing reliable lung ultrasound imaging, such as severe emphysema, chronic pleurisy, or pulmonary fibrosis
- Pregnant women, parturient, or nursing mothers
- Adults under legal protection measures
- Adults unable to give consent
- Persons deprived of liberty by judicial or administrative decision
- Persons under psychiatric care according to specific public health codes
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) for scheduled day hospitalization or consultation
Duration - Day hospitalization or consultation
Participants undergo clinical examinations focused on congestion, including Doppler ultrasounds and blood sample collection for biological assessment and biobanking.
1 visit (in-person) for day hospitalization or consultation
Duration - Up to 24 months
Participants are followed up with telephone calls and quality of life questionnaires to assess health status over time.
Telephone follow-ups at 3, 12, and 24 months; quality of life questionnaires at discharge and 3, 6, 12, and 24 months
Trial Site Locations
Total: 2 locations
1
CHRU de Nancy
Vandœuvre-lès-Nancy, France, 54500
Actively Recruiting
2
CHRU de Nancy
Vandœuvre-lès-Nancy, France, 54500
Not Yet Recruiting
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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