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NCT Number: NCT04332692

Acute Heart Failure - COngestion Discharge Evaluation

Acute heart failure (AHF) is a major public health problem, associated with a 40% risk of death or re-hospitalisation at 3 months. This risk is significantly increased by insufficient decongestion at the end of hospitalisation for AHF assessed by a standardised clinical score, a natriuretic peptide dosage or by cardiac and pulmonary ultrasound .

Adapting treatment according to lung congestion assessed by implantable devices (not reimbursed in France) improves the prognosis. However, due to the lack of a standardised congestion assessment, therapeutic adaptation in acute heart failure is currently empirical. The best multimodality approach to congestion evaluation is uncertain.

Recruiting

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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

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.
  • 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

Cardiac, pulmonary, peritoneal, jugular, renal Doppler ultrasounds and liver elastography

Procedure

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

Blood sample retrieved for biological assessment and biobanking

Procedure

Blood sample retrieved for biological assessment and biobanking will be performed before discharge from hospital

Telephone follow-up

Procedure

Telephone follow-up will be performed 3, 12 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, hospitalization for acute heart failure or day-hospital IV diuretics injection for acute HF during 24 months following day hospitalization (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, hospitalization for acute heart failure or day-hospital IV diuretics injection for acute HF during 24 months following day hospitalization (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, hospitalization for acute heart failure or day-hospital IV diuretics injection for acute HF during 24 months following day hospitalization (with outcome 1 and 2)

Secondary outcomes

  1. Rate of all-cause death

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

  2. Rate of re-hospitalisation for acute heart failure

    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

    Time frame: 12 and 24 months after hospital discharge

    composite endpoint: rate of all-cause death, hospitalization for acute heart failure or day-hospital IV diuretics injection for acute HF at 12 and 24 months following hospitalization (with outcome 8 and 9)

  5. Rate of re-hospitalisation for acute heart failure

    Time frame: 12 and 24 months after hospital discharge

    composite endpoint: rate of all-cause death, hospitalization for acute heart failure or day-hospital IV diuretics injection for acute HF at 12 and 24 months following hospitalization (with outcome 7 and 9)

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

    Time frame: 12 and 24 months after hospital discharge.

    composite endpoint: rate of all-cause death, hospitalization for acute heart failure or day-hospital IV diuretics injection for acute HF at 12 and 24 months following hospitalization (with outcome 7 and 8)

  7. Rate of all-cause death

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

    composite endpoint: rate of all-cause death, hospitalization for acute heart failure or day-hospital IV diuretics injection for acute HF during 24 months following day hospitalization (with outcome 11 and 12)

  8. Rate of hospitalization for acute heart failure

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

    composite endpoint: rate of all-cause death, hospitalization for acute heart failure or day-hospital IV diuretics injection for acute HF during 24 months following day hospitalization (with outcome 10 and 12)

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

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

    composite endpoint: rate of all-cause death, hospitalization for acute heart failure or day-hospital IV diuretics injection for acute HF during 24 months following day hospitalization (with outcome 10 and 11)

  10. NYHA (New York Heart Association) class measured

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

  11. Natriuretic peptides

    Time frame: within 24 months after hospital discharge.

    BNP or Nt-Pro BNP

  12. Renal function assessed by glomerular filtration rate

    Time frame: within 24 months after hospital discharge.

  13. Plasma volume

    Time frame: within 24 months after hospital discharge.

    calculated from haemoglobin and haematocrit value

  14. Liver elastography value

    Time frame: At inclusion

    Measured with Fibroscan

  15. Quality of life

    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

Sanae BOUALI, 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 - COngestion Discharge Evaluation. Évaluation de la Congestion à la Sortie d'Hospitalisation Pour Insuffisance Cardiaque aiguë.

Acronym: AHF-CODE

Important dates

Study start
2020
Primary completion
2026
Study completion
2028
First posted
Apr 3, 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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