Chronic Heart Failure With Preserved Ejection Fraction - COngestion eValuation

Not Applicable

Recruiting

• Conditions: Chronic Heart Failure; Preserved Ejection Fraction
• Interventions: Procedure: Clinical examination centered on congestion; Procedure: Cardiac, pulmonary, peritoneal, jugular and renal Doppler ultrasounds and liver elastography; Procedure: Blood and urine sample retrieved for biological assessment and biobanking; Other: Telephone follow-up; Behavioral: Kansas City Cardiomyopathy Questionnaire (KCCQ)

• Registration Number: NCT05097898
• Lead Sponsor: Central Hospital, Nancy, France

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-11
• Study First Submitted QC: 2021-10-27
• Study First Posted: 2021-10-28
• Study Start: 2022-08-10
• Status Verified: 2023-03
• Last Update Submitted: 2023-06-02
• Last Update Posted: 2023-06-05
• Primary Completion: 2028-12-10
• Study Completion: 2029-06-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with chronic HFpEF coming for scheduled day hospitalization or consultation	Cardiac, pulmonary, peritoneal, jugular and renal Doppler ultrasounds and liver elastography	* Clinical examination focusing on congestion * Cardiac, pulmonary, peritoneal, jugular and renal venous Doppler ultrasounds * Blood sample retrieved for biological assessment and biobanking * Telephone follow-up
Patients with chronic HFpEF coming for scheduled day hospitalization or consultation	Kansas City Cardiomyopathy Questionnaire (KCCQ)	* Clinical examination focusing on congestion * Cardiac, pulmonary, peritoneal, jugular and renal venous Doppler ultrasounds * Blood sample retrieved for biological assessment and biobanking * Telephone follow-up
Patients with chronic HFpEF coming for scheduled day hospitalization or consultation	Telephone follow-up	* Clinical examination focusing on congestion * Cardiac, pulmonary, peritoneal, jugular and renal venous Doppler ultrasounds * Blood sample retrieved for biological assessment and biobanking * Telephone follow-up
Patients with chronic HFpEF coming for scheduled day hospitalization or consultation	Clinical examination centered on congestion	* Clinical examination focusing on congestion * Cardiac, pulmonary, peritoneal, jugular and renal venous Doppler ultrasounds * Blood sample retrieved for biological assessment and biobanking * Telephone follow-up
Patients with chronic HFpEF coming for scheduled day hospitalization or consultation	Blood and urine sample retrieved for biological assessment and biobanking	* Clinical examination focusing on congestion * Cardiac, pulmonary, peritoneal, jugular and renal venous Doppler ultrasounds * Blood sample retrieved for biological assessment and biobanking * Telephone follow-up

Primary Outcome Measures

Name	Time	Method
Rate of day-hospital or in-home IV diuretics injection for acute HF	24 months after inclusion	composite endpoint : rate of death from all causes, hospitalisation for acute heart failure or day-hospital IV diuretics injection for acute HF during 24 months following inclusion (with outcome 1 and 2)
Rate of death from all causes	24 months after inclusion	composite endpoint : rate of death from all causes, hospitalisation for acute heart failure or day-hospital IV diuretics injection for acute HF during 24 months following inclusion (with outcome 2 and 3)
Rate of hospitalisation for acute heart failure	24 months after inclusion	composite endpoint : rate of death from all causes, hospitalisation for acute heart failure or day-hospital IV diuretics injection for acute HF during 24 months following inclusion (with outcome 1 and 3)

Secondary Outcome Measures

Name	Time	Method
Number of B-lines measured in lung echography	At baseline
Rate of bilirubin	At baseline
Rate of ASAT	At baseline
Renal function	At baseline	Assessed by glomerular filtration rate
Plasma volume	At baseline	Calculated from haemoglobin and haematocrit value
Rate of death from all causes	24 months after inclusion	composite endpoint : Rate of death from all causes or hospitalisation for acute heart failure 24 months after inclusion (with outcome 12)
Rate of hospitalisation for cardiovascular reason	24 months after inclusion
Rate of cardiovascular death	24 months after inclusion
NYHA (New York Heart Association) class measured	3, 12 and 24 months after inclusion
Natriuretic peptides	At baseline	BNP or Nt-Pro BNP
Blood potassium concentration	At baseline
Rate of day-hospital or in-home IV diuretics injection for acute HF	24 months after inclusion	composite endpoint: Rate of hospitalisation for acute heart failure or day-hospital/in-home IV diuretics injection for acute HF 24 months after inclusion (with outcome 8)
Rate of V factor	At baseline
Quality of life assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ)	At inclusion and 3, 6 and 24 months
Rate of hospitalisation for acute heart failure	24 months after inclusion	composite endpoint : Rate of death from all causes or hospitalisation for acute heart failure 24 months after inclusion (with outcome 11)
Rate of ALAT	At baseline
Liver elastography value	At inclusion	Measured with Fibroscan®

Trial Locations

Locations (1)

CHRU de Nancy; 🇫🇷 Vandoeuvre Les Nancy, France