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NCT Number: NCT05097898

Chronic Heart Failure With Preserved Ejection Fraction - COngestion eValuation

Heart failure (HF) is a significant cause of death and the leading cause of hospitalization in patients over 65 years of age. Congestion is the main source of symptoms and the leading cause of hospitalization for HF. Furthermore, congestive signs identified in asymptomatic patients are associated with the risk of developing symptomatic HF. The literature supports a multi-modality / integrative evaluation of congestion, combining clinical examination, laboratory results and ultrasound evaluation.

The main objective of the CHF-COV Preserved study is to identify congestion markers (clinical, biological and ultrasound) quantified during a consultation or day hospitalization for the monitoring of chronic HF with preserved left ventricular ejection fraction that are associated with the risk of all-cause death, hospitalization for acute HF or IV diuretics injection in a day hospital.

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Key information

Conditions

Chronic Heart Failure Preserved Ejection Fraction

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 with chronic acute heart failure with preserved ejection fraction admitted in hospital for scheduled day hospitalization or consultation
  • Patient with preserved left ventricular ejection fraction (≥50%).
  • 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 (including the EVEREST, Ambrosy and ASCEND score) will be performed during day hospitalization or consultation

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

Procedure

Cardiac, vena cava, pulmonary, peritoneal, jugular and renal Doppler ultrasounds and liver elastography will be performed during day hospitalization or consultation/ peritoneal, jugular and renal Doppler ultrasounds and liver elastography are optional/Cardiac echo is optional for patients included in consultation

Blood and urine sample retrieved for biological assessment and biobanking

Procedure

Blood sample retrieved for biological assessment and biobanking will be performed during day hospitalization or consultation/ Urine analysis is optional for patients included in consultation

Telephone Follow-up

Other

Telephone follow-up will be performed 3, 12 and 24

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 death from all causes

    Time frame: 24 months after inclusion

    composite endpoint : rate of death from all causes, hospitalisation for acute heart failure or day-hospital IV diuretics injection for acute HF during 24 months following inclusion (with outcome 2 and 3)

  2. Rate of hospitalisation for acute heart failure

    Time frame: 24 months after inclusion

    composite endpoint : rate of death from all causes, hospitalisation for acute heart failure or day-hospital IV diuretics injection for acute HF during 24 months following inclusion (with outcome 1 and 3)

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

    Time frame: 24 months after inclusion

    composite endpoint : rate of death from all causes, hospitalisation for acute heart failure or day-hospital IV diuretics injection for acute HF during 24 months following inclusion (with outcome 1 and 2)

Secondary outcomes

  1. Number of B-lines measured in lung echography

    Time frame: At baseline

  2. Rate of death from all causes

    Time frame: 24 months after inclusion

    composite endpoint : Rate of death from all causes or hospitalisation for acute heart failure 24 months after inclusion (with outcome 6)

  3. Rate of hospitalisation for acute heart failure

    Time frame: 24 months after inclusion

    composite endpoint : Rate of death from all causes or hospitalisation for acute heart failure 24 months after inclusion (with outcome 5)

  4. Rate of death from all causes

    Time frame: 24 months after inclusion

  5. Rate of hospitalisation for acute heart failure

    Time frame: 24 months after day hospitalization

    composite endpoint: Rate of hospitalisation for acute heart failure or day-hospital/in-home IV diuretics injection for acute HF 24 months after inclusion (with outcome 9)

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

    Time frame: 24 months after inclusion

    composite endpoint: Rate of hospitalisation for acute heart failure or day-hospital/in-home IV diuretics injection for acute HF 24 months after inclusion (with outcome 8)

  7. Rate of hospitalisation for cardiovascular reason

    Time frame: 24 months after inclusion

  8. Rate of death from all causes

    Time frame: 24 months after inclusion

    composite endpoint : Rate of death from all causes or hospitalisation for acute heart failure 24 months after inclusion (with outcome 12)

  9. Rate of hospitalisation for acute heart failure

    Time frame: 24 months after inclusion

    composite endpoint : Rate of death from all causes or hospitalisation for acute heart failure 24 months after inclusion (with outcome 11)

  10. Rate of cardiovascular death

    Time frame: 24 months after inclusion

  11. NYHA (New York Heart Association) class measured

    Time frame: 3, 12 and 24 months after inclusion

  12. Natriuretic peptides

    Time frame: At baseline

    BNP or Nt-Pro BNP

  13. Renal function

    Time frame: At baseline

    Assessed by glomerular filtration rate

  14. Plasma volume

    Time frame: At baseline

    Calculated from haemoglobin and haematocrit value

  15. Rate of bilirubin

    Time frame: At baseline

  16. Rate of ASAT

    Time frame: At baseline

  17. Rate of ALAT

    Time frame: At baseline

  18. Rate of V factor

    Time frame: At baseline

  19. Blood potassium concentration

    Time frame: At baseline

  20. Liver elastography value

    Time frame: At inclusion

    Measured with Fibroscan®

  21. Quality of life assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ)

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

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

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

Évaluation de la Congestion en Ambulatoire Chez Les Patients Atteints d'Insuffisance Cardiaque Chronique à Fraction d'éjection préservée. CHF-COV Preserved (Chronic Heart Failure With Preserved Ejection Fraction - COngestion eValuation)

Acronym: CHF-COV-P

Important dates

Study start
2022
Primary completion
2028
Study completion
2029
First posted
Oct 28, 2021
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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