Acute Heart Failure With Preserved Ejection Fraction - COngestion Discharge Evaluation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentral Hospital, Nancy, France

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Clinical examination centered on congestion

    Procedure/Surgery

    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

    Procedure/Surgery

    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

    Procedure/Surgery

    Blood sample collection will be performed before discharge from hospital

  • Telephone interview

    Procedure/Surgery

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

  • Kansas City Cardiomyopathy Questionnaire (KCCQ)

    Behavioral

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

Treatment groups

170 Participants
are divided into 1 treatment group
Group A: Patients hospitalized for acute heart failureOther 5 interventions

Trial outcomes

Primary outcomes

1

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)

Time frame
3 months after hospital discharge
2

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)

Time frame
3 months after hospital discharge
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)

Time frame
3 months after hospital discharge

Secondary outcomes

1

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)

Time frame
3, 12 and 24 months after hospital discharge
2

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)

Time frame
3, 12 and 24 months after hospital discharge
3

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

Time frame
3, 12 and 24 months after hospital discharge
4

Rate of all-cause death

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

Time frame
3, 12 and 24 months after hospital discharge

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.