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AzTrials

Chronic Heart FailureCHF-COV-PNCT05097898

Chronic Heart Failure With Preserved Ejection Fraction - COngestion eValuation

A study testing Clinical examination centered on congestion, Cardiac, pulmonary, peritoneal, jugular and renal Doppler ultrasounds and liver elastography and Blood and urine sample retrieved for biological assessment and biobanking in people with Chronic Heart Failure and Preserved Ejection Fraction, run by Central Hospital, Nancy, France at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Clinical examination centered on congestion, Cardiac, pulmonary, peritoneal, jugular and renal Doppler ultrasounds and liver elastography and Blood and urine sample retrieved for biological assessment and biobanking
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteFrance
Study dates
10 Aug 2022to 10 Jun 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 9Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Nicolas GIRERD, MD, PhD contact

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

n.girerd@chru-nancy.fr

Sanae BOUALI contact

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

s.bouali@chru-nancy.fr

France1 site, 1 recruiting

  • CHRU de Nancy

    Vandœuvre-lès-Nancy, 54500

    Nicolas GIRERD, MD, PhD, +33383157322 ext. +333, n.girerd@chru-nancy.fr

    Recruiting

Other trials in France

About this study

Official 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)

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.

Being tested
Clinical examination centered on congestion, Cardiac, pulmonary, peritoneal, jugular and renal Doppler ultrasounds and liver elastography, Blood and urine sample retrieved for biological assessment and biobanking, Telephone follow-up, Kansas City Cardiomyopathy Questionnaire (KCCQ)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Clinical examination centered on congestionProcedure or surgery

    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 elastographyProcedure or surgery

    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 biobankingProcedure or surgery

    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-upOther

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

  • Kansas City Cardiomyopathy Questionnaire (KCCQ)Behavioural

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

Study groups in NCT05097898
Study groupRoleWhat they receive
Patients with chronic HFpEF coming for scheduled day hospitalization or consultationExperimental* Clinical examination focusing on congestion * Cardiac, pulmonary, peritoneal, jugular and renal venous Doppler ultrasounds * Blood sample retrieved for biological assessment and biobanking * Telephone follow-up
Receives: Procedure: Clinical examination centered on congestion; Procedure: Cardiac, pulmonary, peritoneal, jugular and renal Doppler ultrasounds and liver elastography; Procedure: Blood and urine sample retrieved for biological assessment and biobanking; Other: Telephone follow-up; Behavioral: Kansas City Cardiomyopathy Questionnaire (KCCQ)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of death from all causes

    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)

    Measured: 24 months after inclusion

  2. Rate of hospitalisation for acute heart failure

    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)

    Measured: 24 months after inclusion

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

    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)

    Measured: 24 months after inclusion

Secondary outcomes (21)

  1. Number of B-lines measured in lung echography

    Measured: At baseline

  2. Rate of death from all causes

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

    Measured: 24 months after inclusion

  3. Rate of hospitalisation for acute heart failure

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

    Measured: 24 months after inclusion

  4. Rate of death from all causes

    Measured: 24 months after inclusion

  5. Rate of hospitalisation for acute heart failure

    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)

    Measured: 24 months after day hospitalization

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

    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)

    Measured: 24 months after inclusion

  7. Rate of hospitalisation for cardiovascular reason

    Measured: 24 months after inclusion

  8. Rate of death from all causes

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

    Measured: 24 months after inclusion

  9. Rate of hospitalisation for acute heart failure

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

    Measured: 24 months after inclusion

  10. Rate of cardiovascular death

    Measured: 24 months after inclusion

  11. NYHA (New York Heart Association) class measured

    Measured: 3, 12 and 24 months after inclusion

  12. Natriuretic peptides

    BNP or Nt-Pro BNP

    Measured: At baseline

  13. Renal function

    Assessed by glomerular filtration rate

    Measured: At baseline

  14. Plasma volume

    Calculated from haemoglobin and haematocrit value

    Measured: At baseline

  15. Rate of bilirubin

    Measured: At baseline

  16. Rate of ASAT

    Measured: At baseline

  17. Rate of ALAT

    Measured: At baseline

  18. Rate of V factor

    Measured: At baseline

  19. Blood potassium concentration

    Measured: At baseline

  20. Liver elastography value

    Measured with Fibroscan®

    Measured: At inclusion

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

    Measured: At inclusion and 3, 6 and 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2021
  2. Study start10 Aug 2022
  3. Primary completion10 Dec 2028 (estimated)
  4. Study completion10 Jun 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05097898
Sponsor's protocol ID
2020PI145-3
Acronym
CHF-COV-P
Status last verified
Mar 2023
First submitted
11 Oct 2021
Last updated
5 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Clinical examination centered on congestion, Cardiac, pulmonary, peritoneal, jugular and renal Doppler ultrasounds and liver elastography and Blood and urine sample retrieved for biological assessment and biobanking in people with Chronic Heart Failure and Preserved Ejection Fraction, run by Central Hospital, Nancy, France at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Nicolas GIRERD, MD, PhD (+ 33 3 83 15 73 22 ext. + 33 3, n.girerd@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of death from all causes (time frame: 24 months after inclusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05097898.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2023.

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