Acute Heart Failure With Preserved Ejection Fraction - COngestion Discharge Evaluation

NCT ID: NCT04343430

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

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-29

Study Completion Date

2028-08-29

Brief Summary

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The AHF-CODE preserved study is a prospective, non-randomized, monocenter study performed in patients with heart failure with preserved ejection fraction admitted for worsening heart failure.

The main objective of the AHF-CODE preserved study is to identify congestion markers (clinical, biological and ultrasound) at the end of hospitalization for acute heart failure that are associated with the risk of all cause death or rehospitalization for acute heart failure within 3 months of hospital discharge.

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 centered on congestion
* Cardiopulmonary , peritoneal , jugular and renal venous Doppler ultrasounds
* Blood sample retrieved for biological assessment and biobanking
* Telephone interview

Group Type OTHER

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

Cardio-pulmonary, peritoneal, jugular and renal Doppler ultrasounds and liver elastography

Intervention Type PROCEDURE

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

Biological: Blood sample retrieved for biological assessment and biobanking

Intervention Type PROCEDURE

Blood sample collection will be performed before discharge from hospital

Telephone interview

Intervention Type PROCEDURE

Telephone interview will be performed at 3, 12 months 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

Cardio-pulmonary, peritoneal, jugular and renal Doppler ultrasounds and liver elastography

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

Intervention Type PROCEDURE

Biological: Blood sample retrieved for biological assessment and biobanking

Blood sample collection will be performed before discharge from hospital

Intervention Type PROCEDURE

Telephone interview

Telephone interview will be performed at 3, 12 months 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.
* Patient with preserved ejection fraction (FE ≥ 50%).
* 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

Acute Heart Failure With Preserved Ejection Fraction - COngestion Discharge Evaluation: Evaluation de la Congestion à la Sortie d'Hospitalisation Pour Insuffisance Cardiaque aiguë à Fraction d'éjection préservée

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Facility Contacts

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Nicolas GIRERD, MD,PhD

Role: primary

+33383157322 ext. +333

Other Identifiers

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2019PI188-2

Identifier Type: -

Identifier Source: org_study_id

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