NCT04343430

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
170

participants targeted

Target at P75+ for not_applicable

Timeline
28mo left

Started Aug 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress71%
Aug 2020Aug 2028

First Submitted

Initial submission to the registry

April 9, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 13, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

August 29, 2020

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2026

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 29, 2028

Last Updated

June 5, 2023

Status Verified

March 1, 2023

Enrollment Period

6 years

First QC Date

April 9, 2020

Last Update Submit

June 2, 2023

Conditions

Acute Heart Failure

Outcome Measures

Primary Outcomes (3)

  • 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)

    3 months after hospital discharge

  • 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)

    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 or re-hospitalisation for acute heart failure at 3 months after hospital discharge (with outcome 2 and 3)

    3 months after hospital discharge

Secondary Outcomes (16)

  • 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

    3, 12 and 24 months after hospital discharge

  • Rate of hospitalisation for acute heart failure

    3, 12 and 24 months after hospital discharge

  • +11 more secondary outcomes

Study Arms (1)

Patients hospitalized for acute heart failure

OTHER

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

Procedure: Clinical examination centered on congestionProcedure: Cardio-pulmonary, peritoneal, jugular and renal Doppler ultrasounds and liver elastographyProcedure: Biological: Blood sample retrieved for biological assessment and biobankingProcedure: Telephone interviewBehavioral: 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

Patients hospitalized for acute heart failure
Cardio-pulmonary, peritoneal, jugular and renal Doppler ultrasounds and liver elastographyPROCEDURE

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

Patients hospitalized for acute heart failure
Biological: Blood sample retrieved for biological assessment and biobankingPROCEDURE

Blood sample collection will be performed before discharge from hospital

Patients hospitalized for acute heart failure
Telephone interviewPROCEDURE

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

Patients hospitalized for acute heart failure
Kansas City Cardiomyopathy Questionnaire (KCCQ)BEHAVIORAL

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

Patients hospitalized for acute heart failure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Comorbidity for which the life expectancy is ≤ 3 months
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Nancy

Vandœuvre-lès-Nancy, 54500, France

RECRUITING

MeSH Terms

Interventions

Interviews as Topic

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Central Study Contacts

Nicolas GIRERD, MD,PhD

CONTACT

+ 33 3 83 15 73 22n.girerd@chru-nancy.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI 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 Record Dates

First Submitted

April 9, 2020

First Posted

April 13, 2020

Study Start

August 29, 2020

Primary Completion (Estimated)

August 29, 2026

Study Completion (Estimated)

August 29, 2028

Last Updated

June 5, 2023

Record last verified: 2023-03

Locations

FR(1)