NCT05089162

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-COVReduced study is to identify congestion markers (clinical, biological and ultrasound) quantified during a consultation or day hospitalization for the monitoring of chronic HF with reduced 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
37mo left

Started Dec 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress59%
Dec 2021Jun 2029

First Submitted

Initial submission to the registry

October 11, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 22, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

December 14, 2021

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2029

Last Updated

June 5, 2023

Status Verified

March 1, 2023

Enrollment Period

7 years

First QC Date

October 11, 2021

Last Update Submit

June 2, 2023

Conditions

Chronic Heart FailureReduced Ventricular Ejection Fraction

Outcome Measures

Primary Outcomes (3)

  • 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 day hospitalization (with outcome 2 and 3)

    24 months after day hospitalization or consultation

  • 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 day hospitalization (with outcome 1 and 3)

    24 months after day hospitalization or consultation

  • 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 day hospitalization (with outcome 1 and 2)

    24 months after day hospitalization or consultation

Secondary Outcomes (21)

  • Rate of death from all causes

    24 months after day hospitalization or consultation

  • Rate of hospitalisation for acute heart failure

    24 months after day hospitalization or consultation

  • Rate of death from all causes

    24 months after day hospitalization or consultation

  • Rate of hospitalisation for acute heart failure

    24 months after day hospitalization or consultation

  • Rate of day-hospital or in-home IV diuretics injection for acute HF

    24 months after day hospitalization or consultation

  • +16 more secondary outcomes

Study Arms (1)

Patients with chronic HF with reduced ventricular ejection fraction coming for scheduled day

EXPERIMENTAL
Procedure: Clinical examination centered on congestionProcedure: Cardiac, pulmonary, peritoneal, jugular and renal Doppler ultrasoundsProcedure: Blood sample retrieved for biological assessment and biobankingOther: Telephone follow-upBehavioral: Kansas City Cardiomyopathy Questionnaire (KCCQ)

Interventions

Clinical examination centered on congestionPROCEDURE

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

Patients with chronic HF with reduced ventricular ejection fraction coming for scheduled day
Cardiac, pulmonary, peritoneal, jugular and renal Doppler ultrasoundsPROCEDURE

Cardiac, pulmonary, peritoneal, jugular and renal Doppler ultrasounds and liver elastography will be performed during day hospitalization or consultation/ peritoneal, jugular and renal Doppler ultrasounds are optional

Patients with chronic HF with reduced ventricular ejection fraction coming for scheduled day
Blood sample retrieved for biological assessment and biobankingPROCEDURE

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

Patients with chronic HF with reduced ventricular ejection fraction coming for scheduled day
Telephone follow-upOTHER

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

Patients with chronic HF with reduced ventricular ejection fraction coming for scheduled day
Kansas City Cardiomyopathy Questionnaire (KCCQ)BEHAVIORAL

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

Patients with chronic HF with reduced ventricular ejection fraction coming for scheduled day

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with chronic acute heart failure with reduced ventricular ejection fraction admitted in hospital for scheduled day hospitalization or in consultation
  • Patient with altered (left ventricular ejection fraction \<40%) and moderately altered (left ventricular ejection fraction between 40 and 50%) left ventricular ejection fraction
  • 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.

You may not qualify if:

  • Comorbidity for which the life expectancy is ≤ 3 months
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Nancy

Vandœuvre-lès-Nancy, 54500, France

RECRUITING

Central Study Contacts

Nicolas GIRERD, MD, PhD

CONTACT

0033383157322n.girerd@chru-nancy.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 11, 2021

First Posted

October 22, 2021

Study Start

December 14, 2021

Primary Completion (Estimated)

December 14, 2028

Study Completion (Estimated)

June 14, 2029

Last Updated

June 5, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)