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

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)

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nicolas GIRERD, MD, PhD; Phone Number: + 33 3 + 33 3 83 15 73 22; Email: n.girerd@chru-nancy.fr
• Study Contact Backup: Name: Sanae BOUALI; Phone Number: + 33 3 + 33 3 83 15 73 22; Email: s.bouali@chru-nancy.fr

Study Locations

• France
  • Vandoeuvre Les Nancy, France, 54500
    • Recruiting
    • CHRU de Nancy
    • Contact: Nicolas GIRERD, MD, PhD; Phone Number: +333 +33383157322; Email: n.girerd@chru-nancy.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patients with chronic HFpEF coming for scheduled day hospitalization or consultation; 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

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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of death from all causes	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)	24 months after inclusion
Rate of hospitalisation for acute heart failure	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)	24 months after inclusion
Rate of day-hospital or in-home IV diuretics injection for acute HF	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)	24 months after inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of B-lines measured in lung echography		At baseline
Rate of death from all causes	composite endpoint : Rate of death from all causes or hospitalisation for acute heart failure 24 months after inclusion (with outcome 6)	24 months after inclusion
Rate of hospitalisation for acute heart failure	composite endpoint : Rate of death from all causes or hospitalisation for acute heart failure 24 months after inclusion (with outcome 5)	24 months after inclusion
Rate of death from all causes		24 months after inclusion
Rate of hospitalisation for acute heart failure	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 9)	24 months after day hospitalization
Rate of day-hospital or in-home IV diuretics injection for acute HF	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)	24 months after inclusion
Rate of hospitalisation for cardiovascular reason		24 months after inclusion
Rate of death from all causes	composite endpoint : Rate of death from all causes or hospitalisation for acute heart failure 24 months after inclusion (with outcome 12)	24 months after inclusion
Rate of hospitalisation for acute heart failure	composite endpoint : Rate of death from all causes or hospitalisation for acute heart failure 24 months after inclusion (with outcome 11)	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
Liver elastography value	Measured with Fibroscan®	At inclusion
Quality of life assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ)		At inclusion and 3, 6 and 24 months
Natriuretic peptides	BNP or Nt-Pro BNP	At baseline
Renal function	Assessed by glomerular filtration rate	At baseline
Plasma volume	Calculated from haemoglobin and haematocrit value	At baseline
Rate of bilirubin		At baseline
Rate of ASAT		At baseline
Rate of ALAT		At baseline
Rate of V factor		At baseline
Blood potassium concentration		At baseline

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2022
• Primary Completion (Estimated): December 10, 2028
• Study Completion (Estimated): June 10, 2029

Study Registration Dates

• First Submitted: October 11, 2021
• First Submitted That Met QC Criteria: October 27, 2021
• First Posted (Actual): October 28, 2021

Study Record Updates

• Last Update Posted (Actual): June 5, 2023
• Last Update Submitted That Met QC Criteria: June 2, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 2020PI145-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No