CHF-COVReduced: CHF-COV Reduced (Chronic Heart Failure With Reduced Ejection Fraction - COngestion eValuation)

• Sponsor: Pr. Nicolas GIRERD (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05089162
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 90
• Patients Per Site Per Month: 2.2

Study Details

Study Description

Brief 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. 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-COVReduced study is to identify congestion markers (clinical, biological and ultrasound) in day hospitalization for the monitoring of chronic HF with reduced 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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Heart Failure; Reduced Ventricular Ejection Fraction	Procedure: Clinical examination centered on congestion; Procedure: Cardiac, pulmonary, peritoneal, jugular and renal venous Doppler ultrasounds; Procedure: Blood sample retrieved for biological assessment and biobanking; Other: Telephone follow-up	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Evaluation de la Congestion en Hospitalisation de Jour Pour un Bilan d'Insuffisance Cardiaque Chronique à Fraction d'éjection altérée ou modérément altérée CHF-COV Reduced (Chronic Heart Failure With Reduced Ejection Fraction - COngestion eValuation)
• Actual Study Start Date: Dec 14, 2021
• Anticipated Primary Completion Date: Dec 14, 2028
• Anticipated Study Completion Date: Jun 14, 2029

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Patients with chronic HF with reduced ventricular ejection fraction coming for scheduled day

Procedure: Clinical examination centered on congestion; Clinical examination centered on congestion (including the EVEREST score) will be performed during day hospitalization; Procedure: Cardiac, pulmonary, peritoneal, jugular and renal venous Doppler ultrasounds; Cardiac, pulmonary, peritoneal, jugular and renal venous Doppler ultrasounds will be performed during day hospitalization/ peritoneal, jugular and renal venous Doppler ultrasounds are optional; Procedure: Blood sample retrieved for biological assessment and biobanking; Blood sample retrieved for biological assessment and biobanking will be performed during day hospitalization; Other: Telephone follow-up; Telephone follow-up will be performed 3, 12 and 24 months after day hospitalization

Outcome Measures

Primary Outcome Measures

1. Rate of death from all causes [24 months after day hospitalization]

   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 day hospitalization (with outcome 2 and 3)

2. Rate of hospitalisation for acute heart failure [24 months after day hospitalization]

   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 day hospitalization (with outcome 1 and 3)

3. Rate of day-hospital or in-home IV diuretics injection for acute HF [24 months after day hospitalization]

   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 day hospitalization (with outcome 1 and 2)

Secondary Outcome Measures

1. Rate of death from all causes [24 months after day hospitalization]

   composite endpoint of rate of death from all causes or hospitalisation for acute heart failure 24 months after day hospitalization (with outcome 5)

2. Rate of hospitalisation for acute heart failure [24 months after day hospitalization]

   composite endpoint of rate of death from all causes or hospitalisation for acute heart failure 24 months after day hospitalization (with outcome 4)

3. Rate of death from all causes [24 months after day hospitalization]

4. Rate of hospitalisation for acute heart failure [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 day hospitalization (with outcome 8)

5. Rate of day-hospital or in-home IV diuretics injection for acute HF [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 day hospitalization (with outcome 7)

6. Rate of hospitalisation for cardiovascular reason [24 months after day hospitalization]

7. Rate of death from all causes [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 day hospitalization (with outcome 11)

8. Rate of hospitalisation for acute heart failure [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 day hospitalization (with outcome 10)

9. Rate of cardiovascular death [24 months after day hospitalization]

10. NYHA (New York Heart Association) class measured [3, 12 and 24 months after day hospitalization]

11. Natriuretic peptides [24 months after day hospitalization]

    BNP or Nt-Pro BNP

12. Renal function [24 months after day hospitalization]

    Assessed by glomerular filtration rate

13. Plasma volume [24 months after day hospitalization]

    calculated from haemoglobin and haematocrit value

14. Rate of Bilirubin [24 months after day hospitalization]

15. Rate of ASAT [24 months after day hospitalization]

16. Rate of ALAT [24 months after day hospitalization]

17. Rate of V factor [24 months after day hospitalization]

18. Blood potassium concentration [24 months after day hospitalization]

19. Circulating NtProBNP [24 months after day hospitalization]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients with chronic acute heart failure with reduced ventricular ejection fraction admitted in hospital for scheduled day hospitalization

• Patient with altered (left ventricular ejection fraction <40%) and moderately altered (left ventricular ejection fraction between 40 and 50%) left ventricular ejection fraction

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHRU de Nancy	Vandoeuvre Les Nancy		France	54500

Sponsors and Collaborators

• Pr. Nicolas GIRERD

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pr. Nicolas GIRERD, Principal Investigator, Central Hospital, Nancy, France
• ClinicalTrials.gov Identifier: NCT05089162
• Other Study ID Numbers: 2020PI145-2
• First Posted: Oct 22, 2021
• Last Update Posted: Dec 20, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Heart Failure

Study Results

No Results Posted as of Dec 20, 2021