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

Sponsor

Central Hospital, Nancy, France (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05097898

Collaborator

(none)

200

Enrollment

Location

Arm

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

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) in 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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Heart Failure Preserved Ejection Fraction	Procedure: Clinical examination centered on congestion Procedure: Cardiac, pulmonary, peritoneal, jugular and renal venous Doppler ultrasounds Procedure: Blood sample retrieved for biological assessment and biobanking Other: Telephone follow-up	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Évaluation de la Congestion en Hospitalisation de Jour Pour un Bilan d'Insuffisance Cardiaque Chronique à Fraction d'éjection préservée. CHF-COV Preserved (Chronic Heart Failure With Preserved Ejection Fraction - COngestion eValuation)

Anticipated Study Start Date :

Aug 10, 2022

Anticipated Primary Completion Date :

Dec 10, 2028

Anticipated Study Completion Date :

Jun 10, 2029

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patients with chronic HF with preserved ejection fraction coming for scheduled day hospitalization 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: Clinical examination centered on congestion Clinical examination centered on congestion (including the EVEREST score) will be performed during day hospitalization Procedure: Cardiac, pulmonary, peritoneal, jugular and renal venous Doppler ultrasounds Cardiac, pulmonary, peritoneal, jugular and renal venous Doppler ultrasounds will be performed during day hospitalization/ peritoneal, jugular and renal venous Doppler ultrasounds are optional Procedure: Blood sample retrieved for biological assessment and biobanking Blood sample retrieved for biological assessment and biobanking will be performed during day hospitalization Other: Telephone follow-up Telephone follow-up will be performed 3, 12 and 24

Arm

Intervention/Treatment

Experimental: Patients with chronic HF with preserved ejection fraction coming for scheduled day hospitalization

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: Clinical examination centered on congestion

Clinical examination centered on congestion (including the EVEREST score) will be performed during day hospitalization

Procedure: Cardiac, pulmonary, peritoneal, jugular and renal venous Doppler ultrasounds

Cardiac, pulmonary, peritoneal, jugular and renal venous Doppler ultrasounds will be performed during day hospitalization/ peritoneal, jugular and renal venous Doppler ultrasounds are optional

Procedure: Blood sample retrieved for biological assessment and biobanking

Blood sample retrieved for biological assessment and biobanking will be performed during day hospitalization

Other: Telephone follow-up

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

Outcome Measures

Primary Outcome Measures

Rate of death from all causes [24 months after day hospitalization]
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 day hospitalization (with outcome 2 and 3)
Rate of hospitalisation for acute heart failure [24 months after day hospitalization]
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 day hospitalization (with outcome 1 and 3)
Rate of day-hospital or in-home IV diuretics injection for acute HF [24 months after day hospitalization]
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 day hospitalization (with outcome 1 and 2)

Secondary Outcome Measures

Number of B-lines measured in lung echography [At baseline]
Rate of death from all causes [24 months after day hospitalization]
composite endpoint : Rate of death from all causes or hospitalisation for acute heart failure 24 months after day hospitalization (with outcome 6)
Rate of hospitalisation for acute heart failure [24 months after day hospitalization]
composite endpoint : Rate of death from all causes or hospitalisation for acute heart failure 24 months after day hospitalization (with outcome 5)
Rate of death from all causes [24 months after day hospitalization]
Rate of hospitalisation for acute heart failure [24 months after day hospitalization]
composite endpoint: Rate of hospitalisation for acute heart failure or day-hospital/in-home IV diuretics injection for acute HF 24 months after day hospitalization (with outcome 9)
Rate of day-hospital or in-home IV diuretics injection for acute HF [24 months after day hospitalization]
composite endpoint: Rate of hospitalisation for acute heart failure or day-hospital/in-home IV diuretics injection for acute HF 24 months after day hospitalization (with outcome 8)
Rate of hospitalisation for cardiovascular reason [24 months after day hospitalization]
Rate of death from all causes [24 months after day hospitalization]
composite endpoint : Rate of death from all causes or hospitalisation for acute heart failure 24 months after day hospitalization (with outcome 12)
Rate of hospitalisation for acute heart failure [24 months after day hospitalization]
composite endpoint : Rate of death from all causes or hospitalisation for acute heart failure 24 months after day hospitalization (with outcome 11)
Rate of cardiovascular death [24 months after day hospitalization]
NYHA (New York Heart Association) class measured [3, 12 and 24 months after day hospitalization]
Natriuretic peptides [24 months after day hospitalization]
BNP or Nt-Pro BNP
Renal function [24 months after day hospitalization]
Assessed by glomerular filtration rate
Plasma volume [24 months after day hospitalization]
Calculated from haemoglobin and haematocrit value
Rate of bilirubin [24 months after day hospitalization]
Rate of ASAT [24 months after day hospitalization]
Rate of ALAT [24 months after day hospitalization]
Rate of V factor [24 months after day hospitalization]
Blood potassium concentration [24 months after day hospitalization]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with chronic acute heart failure with preserved ejection fraction admitted in hospital for scheduled day hospitalization
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHRU de Nancy	Vandoeuvre Les Nancy		France	54500

Sponsors and Collaborators

Central Hospital, Nancy, France

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Pr. Nicolas GIRERD, Principal Investigator, Central Hospital, Nancy, France

ClinicalTrials.gov Identifier:

NCT05097898

Other Study ID Numbers:

2020PI145-3

First Posted:

Oct 28, 2021

Last Update Posted:

Jun 30, 2022

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Heart Failure

Study Results

No Results Posted as of Jun 30, 2022