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Recruiting NCT05097898

Chronic Heart Failure With Preserved Ejection Fraction - COngestion eValuation

No phase Interventional Chronic Heart Failure Preserved Ejection Fraction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Clinical examination centered on congestion, Cardiac, pulmonary, peritoneal, jugular and renal Doppler ultrasounds and liver elastography, Blood and urine sample retrieved for biological assessment and biobanking, Telephone follow-up.
Who it may be relevant to
Registry conditions: Chronic Heart Failure, Preserved Ejection Fraction. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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)

Overview

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.

Interventions

  • Procedure Clinical examination centered on congestion
    Clinical examination centered on congestion (including the EVEREST, Ambrosy and ASCEND score) will be performed during day hospitalization or consultation
  • Procedure Cardiac, 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
  • Procedure Blood 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
  • Other Telephone follow-up
    Telephone follow-up will be performed 3, 12 and 24
  • Behavioral Kansas City Cardiomyopathy Questionnaire (KCCQ)
    Questionnaire centered on patient's quality of life at discharge and 3, 12 and 24 months after discharge

Primary outcome measures

  • Rate of death from all causes [Time frame: 24 months after inclusion]
  • Rate of hospitalisation for acute heart failure [Time frame: 24 months after inclusion]
  • Rate of day-hospital or in-home IV diuretics injection for acute HF [Time frame: 24 months after inclusion]
Secondary outcome measures (12)
  • Number of B-lines measured in lung echography [Time frame: At baseline]
  • Rate of death from all causes [Time frame: 24 months after inclusion]
  • Rate of hospitalisation for acute heart failure [Time frame: 24 months after inclusion]
  • Rate of death from all causes [Time frame: 24 months after inclusion]
  • Rate of hospitalisation for acute heart failure [Time frame: 24 months after day hospitalization]
  • Rate of day-hospital or in-home IV diuretics injection for acute HF [Time frame: 24 months after inclusion]
  • Rate of hospitalisation for cardiovascular reason [Time frame: 24 months after inclusion]
  • Rate of death from all causes [Time frame: 24 months after inclusion]
  • Rate of hospitalisation for acute heart failure [Time frame: 24 months after inclusion]
  • Rate of cardiovascular death [Time frame: 24 months after inclusion]
  • NYHA (New York Heart Association) class measured [Time frame: 3, 12 and 24 months after inclusion]
  • Natriuretic peptides [Time frame: At baseline]

Eligibility criteria

Inclusion criteria

  • Patients with chronic acute heart failure with preserved ejection fraction admitted in hospital for scheduled day hospitalization or consultation
  • Patient with preserved left ventricular ejection fraction (≥50%).
  • 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 criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

France · 1 center
  • CHRU de Nancy — Vandœuvre-lès-Nancy

Identifiers

NCT: NCT05097898 · 2020PI145-3

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗