RecruitingNot ApplicableNCT05089162

CHF-COV Reduced (Chronic Heart Failure With Reduced Ejection Fraction - COngestion eValuation)

Evaluation de la Congestion en Hospitalisation de Jour Pour un Bilan d'Insuffisance Cardiaque Chronique à Fraction d'éjection altérée ou modérément altérée CHF-COV Reduced (Chronic Heart Failure With Reduced Ejection Fraction - COngestion eValuation)


Sponsor

Pr. Nicolas GIRERD

Enrollment

200 participants

Start Date

Dec 14, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

Heart failure (HF) is a significant cause of death and the leading cause of hospitalization in patients over 65 years of age. Congestion is the main source of symptoms and the leading cause of hospitalization for HF. Furthermore, congestive signs identified in asymptomatic patients are associated with the risk of developing symptomatic HF. The literature supports a multi-modality / integrative evaluation of congestion, combining clinical examination, laboratory results and ultrasound evaluation. The main objective of the CHF-COVReduced study is to identify congestion markers (clinical, biological and ultrasound) quantified during a consultation or day hospitalization for the monitoring of chronic HF with reduced left ventricular ejection fraction that are associated with the risk of all-cause death, hospitalization for acute HF or IV diuretics injection in a day hospital.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether lung ultrasound can accurately measure fluid congestion in people with heart failure where the heart muscle pumps weakly (reduced ejection fraction). It compares the ultrasound findings with standard methods to see if this simple bedside tool is reliable. **You may be eligible if...** - You have chronic heart failure with a reduced or mildly reduced pumping function (ejection fraction below 50%) - You are being seen at a scheduled hospital visit or clinic - You are 18 or older and have signed the informed consent form **You may NOT be eligible if...** - You have a life expectancy of 3 months or less from another serious illness - You are on dialysis or have severely reduced kidney function - You have had previous lung surgery (removal of a lobe or full lung) - You have severe lung disease that would prevent reliable lung ultrasound (like severe emphysema or pulmonary fibrosis) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREClinical examination centered on congestion

Clinical examination centered on congestion (including the EVEREST, ASCEND and Ambrosy scores) will be performed during day hospitalization or consultation

PROCEDURECardiac, pulmonary, peritoneal, jugular and renal Doppler ultrasounds

Cardiac, pulmonary, peritoneal, jugular and renal Doppler ultrasounds and liver elastography will be performed during day hospitalization or consultation/ peritoneal, jugular and renal Doppler ultrasounds are optional

PROCEDUREBlood sample retrieved for biological assessment and biobanking

Blood sample retrieved for biological assessment and biobanking will be performed during day hospitalization or consultation

OTHERTelephone follow-up

Telephone follow-up will be performed 3, 12 and 24 months after day hospitalization or consultation

BEHAVIORALKansas City Cardiomyopathy Questionnaire (KCCQ)

Questionnaire centered on patient's quality of life at discharge and 3, 12 and 24 months after discharge


Locations(1)

CHRU de Nancy

Vandœuvre-lès-Nancy, France

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NCT05089162


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