Chronic Heart Failure With Preserved Ejection Fraction - COngestion eValuation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentral Hospital, Nancy, France
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Clinical examination centered on congestion
Procedure/SurgeryClinical 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
Procedure/SurgeryCardiac, 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
Procedure/SurgeryBlood 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
Other interventionTelephone follow-up will be performed 3, 12 and 24
Kansas City Cardiomyopathy Questionnaire (KCCQ)
BehavioralQuestionnaire centered on patient's quality of life at discharge and 3, 12 and 24 months after discharge
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Patients with chronic HFpEF coming for scheduled day hospitalization or consultationExperimental treatment 5 interventions
Trial outcomes
Primary outcomes
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)
Time frame
24 months after inclusion2
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)
Time frame
24 months after inclusion3
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)
Time frame
24 months after inclusionSecondary outcomes
1
Number of B-lines measured in lung echography
Time frame
At baseline2
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)
Time frame
24 months after inclusion3
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)
Time frame
24 months after inclusion4
Rate of death from all causes
Time frame
24 months after inclusionSponsors and contacts
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Source ClinicalTrials.gov