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Acute Heart Failure With Preserved Ejection Fraction - COngestion Discharge Evaluation (AHF-CODE-P)

Primary Purpose

Acute Heart Failure

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Clinical examination centered on congestion

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

Biological: Blood sample retrieved for biological assessment and biobanking

Telephone interview

Kansas City Cardiomyopathy Questionnaire (KCCQ)

About this trial

This is an interventional diagnostic trial for Acute Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.
Valvulopathy causing decompensation of heart failure for which intervention is being considered.
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.

Sites / Locations

CHRU de NancyRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patients hospitalized for acute heart failure

Arm Description

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

Outcomes

Primary Outcome Measures

Rate of all-cause death

composite endpoint : rate of all-cause death or re-hospitalisation for acute heart failure at 3 months after hospital discharge (with outcome 2 and 3)

Rate of re-hospitalisation for acute heart failure

composite endpoint : rate of all-cause death or re-hospitalisation for acute heart failure at 3 months after hospital discharge (with outcome 1 and 3)

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

composite endpoint : rate of all-cause death or re-hospitalisation for acute heart failure at 3 months after hospital discharge (with outcome 2 and 3)

Secondary Outcome Measures

Rate of all-cause death

composite endpoint : rate of all-cause death or re-hospitalisation for acute heart failure at 3,12 and 24 months after hospital discharge (with outcome 5)

Rate of re-hospitalisation for acute heart failure

composite endpoint : rate of all-cause death or re-hospitalisation for acute heart failure at 3, 12 and 24 months after hospital discharge (with outcome 4)

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

Rate of all-cause death

Rate of all-cause death at 3, 12 and 24 months after hospital discharge

Rate of hospitalisation for acute heart failure

Rate of hospitalisation for acute heart Failure at 3, 12 and 24 months after hospital discharge

Rate of all-cause death

composite endpoint : rate of all-cause death or re-hospitalisation for acute heart failure at 3 months after hospital discharge (with outcome 10)

Rate of hospitalisation for acute heart failure

composite endpoint : rate of all-cause death or re-hospitalisation for acute heart failure at 3 months after hospital discharge (with outcome 9)

Rate of death from all causes

composite endpoint : rate of all-cause death or re-hospitalisation for acute heart failure at 3, 12 and 24 months after hospital discharge (with outcome 12)

Rate of hospitalisation for acute heart failure

composite endpoint : rate of all-cause death or re-hospitalisation for acute heart failure at 3, 12 and 24 months after hospital discharge (with outcome 11)

NYHA (New York Heart Association) class

Natriuretic peptides

BNP or Nt-Pro BNP

Renal function assessed by glomerular filtration rate

Plasma volume

Calculated from haemoglobin and haematocrit value

Blood potassium

Liver elastography value

Measured with Fibroscan®

Quality of life assessed by Kansas City Cardiomyopathy Questionnaire

Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ)

Full Information

NCT ID

NCT04343430

First Posted

April 9, 2020

Last Updated

June 2, 2023

Sponsor

Central Hospital, Nancy, France

1. Study Identification

Unique Protocol Identification Number

NCT04343430

Brief Title

Acute Heart Failure With Preserved Ejection Fraction - COngestion Discharge Evaluation

Acronym

AHF-CODE-P

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 29, 2020 (Actual)

Primary Completion Date

August 29, 2026 (Anticipated)

Study Completion Date

August 29, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Central Hospital, Nancy, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Heart Failure

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Patients hospitalized for acute heart failure

Arm Type

Other

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Clinical examination centered on congestion

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

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

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Biological: Blood sample retrieved for biological assessment and biobanking

Intervention Description

Blood sample collection will be performed before discharge from hospital

Intervention Type

Procedure

Intervention Name(s)

Telephone interview

Intervention Description

Telephone interview will be performed at 3, 12 months and 24 months after discharge from Hospital

Intervention Type

Behavioral

Intervention Name(s)

Kansas City Cardiomyopathy Questionnaire (KCCQ)

Intervention Description

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

Primary Outcome Measure Information:

Title

Rate of all-cause death

Description

composite endpoint : rate of all-cause death or re-hospitalisation for acute heart failure at 3 months after hospital discharge (with outcome 2 and 3)

Time Frame

3 months after hospital discharge

Title

Rate of re-hospitalisation for acute heart failure

Description

composite endpoint : rate of all-cause death or re-hospitalisation for acute heart failure at 3 months after hospital discharge (with outcome 1 and 3)

Time Frame

3 months after hospital discharge

Title

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

Description

composite endpoint : rate of all-cause death or re-hospitalisation for acute heart failure at 3 months after hospital discharge (with outcome 2 and 3)

Time Frame

3 months after hospital discharge

Secondary Outcome Measure Information:

Title

Rate of all-cause death

Description

composite endpoint : rate of all-cause death or re-hospitalisation for acute heart failure at 3,12 and 24 months after hospital discharge (with outcome 5)

Time Frame