RecruitingNot ApplicableNCT05097898

Chronic Heart Failure With Preserved Ejection Fraction - COngestion eValuation

Évaluation de la Congestion en Ambulatoire Chez Les Patients Atteints d'Insuffisance Cardiaque Chronique à Fraction d'éjection préservée. CHF-COV Preserved (Chronic Heart Failure With Preserved Ejection Fraction - COngestion eValuation)


Sponsor

Central Hospital, Nancy, France

Enrollment

200 participants

Start Date

Aug 10, 2022

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-COV Preserved study is to identify congestion markers (clinical, biological and ultrasound) quantified during a consultation or day hospitalization for the monitoring of chronic HF with preserved 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 buildup (congestion) in people with heart failure where the heart muscle pumps with preserved strength (preserved ejection fraction, or HFpEF). This simple bedside imaging tool may help doctors better gauge how much fluid is in the lungs. **You may be eligible if...** - You have been diagnosed with chronic heart failure with preserved ejection fraction (pumping function ≥ 50%) - You are being seen at a scheduled hospital visit or clinic appointment - 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 due to another illness - You are on dialysis or have severely reduced kidney function - You have had previous lung surgery (removal of a lobe or entire lung) - You have severe lung disease that would make lung ultrasound images unreliable (e.g., severe emphysema, pulmonary fibrosis) - You are pregnant or breastfeeding - You are under a legal protection measure or unable to give consent 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, Ambrosy and ASCEND score) will be performed during day hospitalization or consultation

PROCEDURECardiac, pulmonary, peritoneal, jugular and renal Doppler ultrasounds and liver elastography

Cardiac, vena cava, pulmonary, peritoneal, jugular and renal Doppler ultrasounds and liver elastography will be performed during day hospitalization or consultation/ peritoneal, jugular and renal Doppler ultrasounds and liver elastography are optional/Cardiac echo is optional for patients included in consultation

PROCEDUREBlood and urine sample retrieved for biological assessment and biobanking

Blood sample retrieved for biological assessment and biobanking will be performed during day hospitalization or consultation/ Urine analysis is optional for patients included in consultation

OTHERTelephone follow-up

Telephone follow-up will be performed 3, 12 and 24

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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NCT05097898


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