RecruitingNot ApplicableNCT05089149

Chronic Heart Failure - COngestion eValuation

Évaluation de la Congestion en Ambulatoire Chez Les Patients Atteints d'Insuffisance Cardiaque Chronique. CHF-COV (Chronic Heart Failure - 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-COV study is to identify congestion markers (clinical, biological and ultrasound) quantified during a consultation or day hospitalization for the monitoring of chronic HF that are associated with the risk of all-cause death or hospitalization for acute HF within 24 months after day hospitalization.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • Patients with chronic acute heart failure admitted in hospital for scheduled day hospitalization or consultation
  • Age ≥18 years
  • Patients having received complete information regarding the study design and having signed their informed consent form.
  • Patient affiliated to or beneficiary of a social security scheme.

Exclusion Criteria9

  • Comorbidity for which the life expectancy is ≤ 3 months
  • Dialysis patient (peritoneal dialysis or hemodialysis) or patients with glomerular filtration rate \<15 ml/min/m2 at inclusion.
  • History of lobectomy or pneumonectomy lung surgery
  • Severe pulmonary or pleural pathology preventing reliable acquisition of lung ultrasound images: severe emphysema, chronic pleurisy, pulmonary fibrosis, etc.
  • Pregnant woman, parturient or nursing mother
  • Adult person subject to a legal protection measure (guardianship, curatorship, safeguard of justice)
  • Adult person who is unable to give consent
  • Person deprived of liberty by a judicial or administrative decision,
  • Person subject to psychiatric care pursuant to Articles L. 3212-1 and L. 3213-1 of the Public Health Code.

Interventions

PROCEDUREClinical examination centered on congestion

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

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

Cardiac, pulmonary, peritoneal, jugular and renal Doppler ultrasounds will be performed during day hospitalization or consultation/ peritoneal, jugular and renal Doppler ultrasounds and liver elastography 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 visit (during 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(2)

CHRU de Nancy

Vandœuvre-lès-Nancy, France

CHRU de Nancy

Vandœuvre-lès-Nancy, France

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NCT05089149


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