Chronic Heart Failure With Preserved Ejection Fraction - COngestion eValuation

NCT ID: NCT05097898

Last Updated: 2023-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-10

Study Completion Date

2029-06-10

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Heart Failure Preserved Ejection Fraction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patients with chronic HFpEF coming for scheduled day hospitalization or consultation

* 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

Group Type EXPERIMENTAL

Clinical examination centered on congestion

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type OTHER

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

Kansas City Cardiomyopathy Questionnaire (KCCQ)

Intervention Type BEHAVIORAL

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

Interventions

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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

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

Telephone follow-up

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

Intervention Type OTHER

Kansas City Cardiomyopathy Questionnaire (KCCQ)

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Pr. Nicolas GIRERD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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CHRU de Nancy

Vandœuvre-lès-Nancy, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Nicolas GIRERD, MD, PhD

Role: CONTACT

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

Sanae BOUALI

Role: CONTACT

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

Facility Contacts

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Nicolas GIRERD, MD, PhD

Role: primary

+33383157322 ext. +333

Other Identifiers

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2020PI145-3

Identifier Type: -

Identifier Source: org_study_id

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