Acute Heart Failure - COngestion Discharge Evaluation

NCT ID: NCT04332692

Last Updated: 2023-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-15

Study Completion Date

2028-05-20

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Heart Failure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patients hospitalized for acute heart failure

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

Group Type EXPERIMENTAL

Clinical examination centered on congestion

Intervention Type PROCEDURE

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

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

Intervention Type PROCEDURE

Cardiac, pulmonary, peritoneal, jugular and renal Doppler ultrasounds and liver elastography will be performed before discharge from hospital

Blood sample retrieved for biological assessment and biobanking

Intervention Type PROCEDURE

Blood sample retrieved for biological assessment and biobanking will be performed before discharge from hospital

Telephone follow-up

Intervention Type PROCEDURE

Telephone follow-up will be performed 3, 12 and 24 months after discharge from hospital

Kansas City Cardiomyopathy Questionnaire (KCCQ)

Intervention Type BEHAVIORAL

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

Interventions

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Clinical examination centered on congestion

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

Intervention Type PROCEDURE

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

Cardiac, pulmonary, peritoneal, jugular and renal Doppler ultrasounds and liver elastography will be performed before discharge from hospital

Intervention Type PROCEDURE

Blood sample retrieved for biological assessment and biobanking

Blood sample retrieved for biological assessment and biobanking will be performed before discharge from hospital

Intervention Type PROCEDURE

Telephone follow-up

Telephone follow-up will be performed 3, 12 and 24 months after discharge from hospital

Intervention Type PROCEDURE

Kansas City Cardiomyopathy Questionnaire (KCCQ)

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Patients hospitalised for acute heart failure.
* Patients considered clinically discharging from hospitalisation for acute heart failure.
* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Pr. Nicolas GIRERD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nicolas GIRERD, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

CHRU of Nancy

Locations

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CHRU de Nancy

Vandœuvre-lès-Nancy, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Nicolas GIRERD, MD,PhD

Role: CONTACT

+ 33 3 83 15 73 22 ext. + 33 3

Sanae BOUALI, PhD

Role: CONTACT

+ 33 3 83 15 73 22 ext. + 33 3

Facility Contacts

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Nicolas GIRERD, MD, PhD

Role: primary

+33383157322 ext. +333

Other Identifiers

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2019-A03311-56

Identifier Type: -

Identifier Source: org_study_id

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