Chronic Heart Failure With Preserved Ejection Fraction - COngestion eValuation

Chronic Heart Failure Clinical Trial

— CHF-COV-P  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05097898
• Other study ID #: 2020PI145-3
• Status: Recruiting
• Phase: N/A
• Start date: August 10, 2022
• Est. completion date: June 10, 2029

Study information

• Verified date: March 2023
• Source: Central Hospital, Nancy, France
• Contact: Nicolas GIRERD, MD, PhD
• Phone: + 33 3 83 15 73 22
• Email: n.girerd[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 10, 2029
• Est. primary completion date: December 10, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure
• Preserved Ejection Fraction

Intervention

Procedure:
• Clinical examination centered on congestion
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
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
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

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

Behavioral:
• Kansas City Cardiomyopathy Questionnaire (KCCQ)
Questionnaire centered on patient's quality of life at discharge and 3, 12 and 24 months after discharge

Locations

Country	Name	City	State
France	CHRU de Nancy	Vandoeuvre Les Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	24 months after inclusion
Primary	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)	24 months after inclusion
Primary	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)	24 months after inclusion
Secondary	Number of B-lines measured in lung echography		At baseline
Secondary	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)	24 months after inclusion
Secondary	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)	24 months after inclusion
Secondary	Rate of death from all causes		24 months after inclusion
Secondary	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)	24 months after day hospitalization
Secondary	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)	24 months after inclusion
Secondary	Rate of hospitalisation for cardiovascular reason		24 months after inclusion
Secondary	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)	24 months after inclusion
Secondary	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)	24 months after inclusion
Secondary	Rate of cardiovascular death		24 months after inclusion
Secondary	NYHA (New York Heart Association) class measured		3, 12 and 24 months after inclusion
Secondary	Natriuretic peptides	BNP or Nt-Pro BNP	At baseline
Secondary	Renal function	Assessed by glomerular filtration rate	At baseline
Secondary	Plasma volume	Calculated from haemoglobin and haematocrit value	At baseline
Secondary	Rate of bilirubin		At baseline
Secondary	Rate of ASAT		At baseline
Secondary	Rate of ALAT		At baseline
Secondary	Rate of V factor		At baseline
Secondary	Blood potassium concentration		At baseline
Secondary	Liver elastography value	Measured with Fibroscan®	At inclusion
Secondary	Quality of life assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ)		At inclusion and 3, 6 and 24 months