Brief Summary

Acute heart failure (AHF) is a major public health problem, associated with a 40% risk of death or re-hospitalisation at 3 months. This risk is significantly increased by insufficient decongestion at the end of hospitalisation for AHF assessed by a standardised clinical score, a natriuretic peptide dosage or by cardiac and pulmonary ultrasound . Adapting treatment according to lung congestion assessed by implantable devices (not reimbursed in France) improves the prognosis. However, due to the lack of a standardised congestion assessment, therapeutic adaptation in acute heart failure is currently empirical. The best multimodality approach to congestion evaluation is uncertain.

Trial Health

On Track

Trial Health Score

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

Enrollment

110

participants targeted

Target at P50-P75 for not_applicable

Timeline

25mo left

Started Jul 2020

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

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Study Timeline

Key milestones and dates

7.9 years study duration

Study Progress74%

Jul 2020May 2028

First Submitted

Initial submission to the registry

March 12, 2020

Completed

22 days until next milestone

First Posted

Study publicly available on registry

April 3, 2020

Completed

3 months until next milestone

Study Start

First participant enrolled

July 15, 2020

Completed

6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2026

Expected

1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2028

Last Updated

June 5, 2023

Status Verified

March 1, 2023

Enrollment Period

6.1 years

First QC Date

March 12, 2020

Last Update Submit

June 2, 2023

Conditions

Acute Heart Failure

Keywords

Acute Heart Failure

Outcome Measures

Primary Outcomes (3)

Rate of all-cause death
composite endpoint: rate of all-cause death, hospitalization for acute heart failure or day-hospital IV diuretics injection for acute HF during 24 months following day hospitalization (with outcome 2 and 3)
3 months after hospital discharge
Rate of re-hospitalisation for acute heart failure
composite endpoint: rate of all-cause death, hospitalization for acute heart failure or day-hospital IV diuretics injection for acute HF during 24 months following day hospitalization (with outcome 1 and 3)
3 months after hospital discharge
Rate of day-hospital or in-home IV diuretics injection for acute HF
composite endpoint: rate of all-cause death, hospitalization for acute heart failure or day-hospital IV diuretics injection for acute HF during 24 months following day hospitalization (with outcome 1 and 2)
3 months after hospital discharge

Secondary Outcomes (15)

Rate of all-cause death
3, 12 and 24 months after hospital discharge
Rate of re-hospitalisation for acute heart failure
3,12 and 24 months after hospital discharge
Rate of day-hospital or in-home IV diuretics injection for acute HF
3,12 and 24 months after hospital discharge
Rate of all-cause death
12 and 24 months after hospital discharge
Rate of re-hospitalisation for acute heart failure
12 and 24 months after hospital discharge
+10 more secondary outcomes

Study Arms (1)

Patients hospitalized for acute heart failure

EXPERIMENTAL

Patients hospitalized for acute heart failure will undergo the following evaluations: * 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 biobankingProcedure: Telephone follow-upBehavioral: Kansas City Cardiomyopathy Questionnaire (KCCQ)

Interventions

Clinical examination centered on congestionPROCEDURE

Clinical examination centered on congestion (ASCEND, NYHA and Ambrosy Score) will be performed before discharge from hospital