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NCT Number: NCT04343430

Acute Heart Failure With Preserved Ejection Fraction - COngestion Discharge Evaluation

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.

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Key information

Conditions

Acute Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU de Nancy

Vandœuvre-lès-Nancy, 54500, France

Location status: Recruiting

Location contact

Nicolas GIRERD, MD,PhD

CONTACT

[email protected]

+33383157322 ext. +333

Nicolas GIRERD, MD,PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clinical examination centered on congestion

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

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

Procedure

Blood sample collection will be performed before discharge from hospital

Telephone interview

Procedure

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

Primary outcomes

  1. Rate of all-cause death

    Time frame: 3 months after hospital discharge

    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)

  2. Rate of re-hospitalisation for acute heart failure

    Time frame: 3 months after hospital discharge

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

    Time frame: 3 months after hospital discharge

    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 outcomes

  1. Rate of all-cause death

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

    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)

  2. Rate of re-hospitalisation for acute heart failure

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

    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)

  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

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

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

  5. Rate of hospitalisation for acute heart failure

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

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

  6. Rate of all-cause death

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

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

  7. Rate of hospitalisation for acute heart failure

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

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

  8. Rate of death from all causes

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

    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)

  9. Rate of hospitalisation for acute heart failure

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

    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)

  10. NYHA (New York Heart Association) class

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

  11. Natriuretic peptides

    Time frame: At inclusion

    BNP or Nt-Pro BNP

  12. Renal function assessed by glomerular filtration rate

    Time frame: At inclusion

  13. Plasma volume

    Time frame: At inclusion

    Calculated from haemoglobin and haematocrit value

  14. Blood potassium

    Time frame: At inclusion

  15. Liver elastography value

    Time frame: At inclusion

    Measured with Fibroscan®

  16. Quality of life assessed by Kansas City Cardiomyopathy Questionnaire

    Time frame: At inclusion and 3, 6 and 24 months

    Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ)

Study contacts

Contact information is provided by the study sponsor or research team.

Nicolas GIRERD, MD,PhD

CONTACT

[email protected]

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

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study 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

Acronym: AHF-CODE-P

Important dates

Study start
2020
Primary completion
2026
Study completion
2028
First posted
Apr 13, 2020
Registry last updated
Jun 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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