NCT05097898Recruiting
Chronic Heart Failure With Preserved Ejection Fraction - COngestion eValuation
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)
Source: ClinicalTrials.gov · Last updated 5 Jun 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 11 Oct 2021
- Start date
- 10 Aug 2022
- Primary completion date
- 10 Dec 2028
- Lead sponsor
- Central Hospital, Nancy, France
- Diseases
- Heart failure
- NCT number
- NCT05097898
What you commit to
- Study type: Interventional
- Planned participants: 200
- From 10 Aug 2022 to the primary completion date, 10 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of lobectomy or pneumonectomy lung surgery
- Person subject to psychiatric care pursuant to Articles L. 3212-1 and L. 3213-1 of the Public Health Code.
Other
- 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.
- 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,
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHRU de Nancy Coordinator of this site? Confirm its status | Vandœuvre-lès-Nancy | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.