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Chronic Heart Failure With Preserved Ejection Fraction - COngestion eValuation (CHF-COV-P)

Primary Purpose

Chronic Heart Failure, Preserved Ejection Fraction

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
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)
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chronic Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Sites / Locations

  • CHRU de NancyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with chronic HFpEF coming for scheduled day hospitalization or consultation

Arm Description

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

Outcomes

Primary Outcome Measures

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)
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)
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)

Secondary Outcome Measures

Number of B-lines measured in lung echography
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)
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)
Rate of death from all causes
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)
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)
Rate of hospitalisation for cardiovascular reason
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)
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)
Rate of cardiovascular death
NYHA (New York Heart Association) class measured
Natriuretic peptides
BNP or Nt-Pro BNP
Renal function
Assessed by glomerular filtration rate
Plasma volume
Calculated from haemoglobin and haematocrit value
Rate of bilirubin
Rate of ASAT
Rate of ALAT
Rate of V factor
Blood potassium concentration
Liver elastography value
Measured with Fibroscan®
Quality of life assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ)

Full Information

First Posted
October 11, 2021
Last Updated
June 2, 2023
Sponsor
Central Hospital, Nancy, France
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1. Study Identification

Unique Protocol Identification Number
NCT05097898
Brief Title
Chronic Heart Failure With Preserved Ejection Fraction - COngestion eValuation
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 10, 2022 (Actual)
Primary Completion Date
December 10, 2028 (Anticipated)
Study Completion Date
June 10, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central Hospital, Nancy, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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-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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure, Preserved Ejection Fraction

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with chronic HFpEF coming for scheduled day hospitalization or consultation
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Clinical examination centered on congestion
Intervention Description
Clinical examination centered on congestion (including the EVEREST, Ambrosy and ASCEND score) will be performed during day hospitalization or consultation
Intervention Type
Procedure
Intervention Name(s)
Cardiac, pulmonary, peritoneal, jugular and renal Doppler ultrasounds and liver elastography
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Blood and urine sample retrieved for biological assessment and biobanking
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Telephone follow-up
Intervention Description
Telephone follow-up will be performed 3, 12 and 24
Intervention Type
Behavioral
Intervention Name(s)
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Intervention Description
Questionnaire centered on patient's quality of life at discharge and 3, 12 and 24 months after discharge
Primary Outcome Measure Information:
Title
Rate of death from all causes
Description
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)
Time Frame
24 months after inclusion
Title
Rate of hospitalisation for acute heart failure
Description
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)
Time Frame
24 months after inclusion
Title
Rate of day-hospital or in-home IV diuretics injection for acute HF
Description
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)
Time Frame
24 months after inclusion
Secondary Outcome Measure Information:
Title
Number of B-lines measured in lung echography
Time Frame
At baseline
Title
Rate of death from all causes
Description
composite endpoint : Rate of death from all causes or hospitalisation for acute heart failure 24 months after inclusion (with outcome 6)
Time Frame
24 months after inclusion
Title
Rate of hospitalisation for acute heart failure
Description
composite endpoint : Rate of death from all causes or hospitalisation for acute heart failure 24 months after inclusion (with outcome 5)
Time Frame
24 months after inclusion
Title
Rate of death from all causes
Time Frame
24 months after inclusion
Title
Rate of hospitalisation for acute heart failure
Description
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)
Time Frame
24 months after day hospitalization
Title
Rate of day-hospital or in-home IV diuretics injection for acute HF
Description
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)
Time Frame
24 months after inclusion
Title
Rate of hospitalisation for cardiovascular reason
Time Frame
24 months after inclusion
Title
Rate of death from all causes
Description
composite endpoint : Rate of death from all causes or hospitalisation for acute heart failure 24 months after inclusion (with outcome 12)
Time Frame
24 months after inclusion
Title
Rate of hospitalisation for acute heart failure
Description
composite endpoint : Rate of death from all causes or hospitalisation for acute heart failure 24 months after inclusion (with outcome 11)
Time Frame
24 months after inclusion
Title
Rate of cardiovascular death
Time Frame
24 months after inclusion
Title
NYHA (New York Heart Association) class measured
Time Frame
3, 12 and 24 months after inclusion
Title
Natriuretic peptides
Description
BNP or Nt-Pro BNP
Time Frame
At baseline
Title
Renal function
Description
Assessed by glomerular filtration rate
Time Frame
At baseline
Title
Plasma volume
Description
Calculated from haemoglobin and haematocrit value
Time Frame
At baseline
Title
Rate of bilirubin
Time Frame
At baseline
Title
Rate of ASAT
Time Frame
At baseline
Title
Rate of ALAT
Time Frame
At baseline
Title
Rate of V factor
Time Frame
At baseline
Title
Blood potassium concentration
Time Frame
At baseline
Title
Liver elastography value
Description
Measured with Fibroscan®
Time Frame
At inclusion
Title
Quality of life assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time Frame
At inclusion and 3, 6 and 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicolas GIRERD, MD, PhD
Phone
+ 33 3 83 15 73 22
Ext
+ 33 3
Email
n.girerd@chru-nancy.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Sanae BOUALI
Phone
+ 33 3 83 15 73 22
Ext
+ 33 3
Email
s.bouali@chru-nancy.fr
Facility Information:
Facility Name
CHRU de Nancy
City
Vandoeuvre Les Nancy
ZIP/Postal Code
54500
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas GIRERD, MD, PhD
Phone
+33383157322
Ext
+333
Email
n.girerd@chru-nancy.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Chronic Heart Failure With Preserved Ejection Fraction - COngestion eValuation

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