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.

Trial Health

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

2 active sites

Status

recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

7.5 years study duration

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 Failure

Outcome Measures

Primary Outcomes (2)

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)
24 months after day hospitalization or consultation
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)
24 months after day hospitalization or consultation

Secondary Outcomes (17)

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 hospitalisation for cardiovascular reason
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
+12 more secondary outcomes

Study Arms (1)

Patients with chronic heart failure coming for scheduled day hospitalization

EXPERIMENTAL

* 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 congestionProcedure: Cardiac, pulmonary, peritoneal, jugular, renal Doppler ultrasounds and liver elastographyProcedure: Blood sample retrieved for biological assessment and biobankingOther: Telephone follow-upBehavioral: Kansas City Cardiomyopathy Questionnaire (KCCQ)

Interventions

Clinical examination centered on congestionPROCEDURE

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