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Chronic Heart Failure - COngestion eValuation (CHF-COV)

Primary Purpose

Chronic Heart Failure

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Clinical examination centered on congestion

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

Blood sample retrieved for biological assessment and biobanking

Telephone follow-up

Kansas City Cardiomyopathy Questionnaire (KCCQ)

About this trial

This is an interventional diagnostic trial for Chronic Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Sites / Locations

CHRU de NancyRecruiting
CHRU de Nancy

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with chronic heart failure coming for scheduled day hospitalization

Arm Description

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

Outcomes

Primary Outcome Measures

Rate of death from all causes

composite endpoint : rate of death from all causes or hospitalisation for acute heart failure during 24 months following day hospitalization (with outcome 2)

Rate of hospitalisation for acute heart failure

composite endpoint : rate of death from all causes or hospitalisation for acute heart failure during 24 months following day hospitalization (with outcome 1)

Secondary Outcome Measures

Rate of death from all causes

Rate of hospitalisation for acute heart failure

Rate of hospitalisation for cardiovascular reason

Rate of death from all causes

composite endpoint : Rate of death from all causes or hospitalisation for acute heart failure 24 months after day hospitalization (with outcome 7)

Rate of hospitalisation for acute heart failure

composite endpoint : Rate of death from all causes or hospitalisation for acute heart failure 24 months after day hospitalization (with outcome 6)

Rate of cardiovascular death

NYHA (New York Heart Association) class measured

Natriuretic peptides

BNP or Nt-Pro BNP

Renal function assessed by glomerular filtration rate

Plasma volume

Calculated from haemoglobin and haematocrit value

Rate of Bilirubin

Rate of ASAT

Rate of ALAT

Rate of V factor

Blood potassium concentration

Liver elastography value

Measured with Fibroscan®

Quality of life assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ)

Full Information

NCT ID

NCT05089149

First Posted

October 11, 2021

Last Updated

June 2, 2023

Sponsor

Pr. Nicolas GIRERD

1. Study Identification

Unique Protocol Identification Number

NCT05089149

Brief Title

Chronic Heart Failure - COngestion eValuation

Acronym

CHF-COV

Official Title

Évaluation de la Congestion en Ambulatoire Chez Les Patients Atteints d'Insuffisance Cardiaque Chronique. CHF-COV (Chronic Heart Failure - COngestion eValuation)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 14, 2021 (Actual)

Primary Completion Date

December 14, 2028 (Anticipated)

Study Completion Date

June 14, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Pr. Nicolas GIRERD

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Heart Failure

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Patients with chronic heart failure coming for scheduled day hospitalization

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Clinical examination centered on congestion

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

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

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Blood sample retrieved for biological assessment and biobanking

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Telephone follow-up

Intervention Description

Telephone follow-up will be performed 3, 12 and 24 months after visit (during day hospitalization or consultation)

Intervention Type

Behavioral

Intervention Name(s)

Kansas City Cardiomyopathy Questionnaire (KCCQ)

Intervention Description

Questionnaire centered on patient's quality of life at discharge and 3, 12 and 24 months after discharge

Primary Outcome Measure Information:

Title

Rate of death from all causes

Description

composite endpoint : rate of death from all causes or hospitalisation for acute heart failure during 24 months following day hospitalization (with outcome 2)

Time Frame