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NCT05209919: ECLIPSE-HF
Echocardiographic Assessment and CLInical imPlication of Functional tricuSpid rEgurgitation in Heart Failure With Reduced or Preserved Ejection Fraction
trial testing Transthoracic Echocardiography in Functional Tricuspid Regurgitation in 400 participants. Status unknown.
1 December 2023
Quick facts
| Lead sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 400 |
| Start date | 11 November 2021 |
| Primary completion | 1 December 2023 |
| Estimated completion | 1 December 2024 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Transthoracic Echocardiography
Conditions studied
- Functional Tricuspid Regurgitation — all drugs for Functional Tricuspid Regurgitation →
Sponsor
Fondazione IRCCS Policlinico San Matteo di Pavia
Who can join
18 and older, any sex, with Functional Tricuspid Regurgitation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Purpose Functional tricuspid regurgitation (FTR) has been shown to be associated with increased morbidity and mortality in several clinical conditions, including heart failure (HF) with reduced left ventricular ejection fraction as well as pulmonary arterial hypertension (PAH). We have designed a study aiming at: characterizing the echocardiographic morphology of the tricuspid valve apparatus and the pathophysiology of FTR in heart failure with reduced, mid-range or preserved left ventricular ejection fraction (HFrEF, HFmrEF, HFpEF) and in PAH patients; correlating the morphologic characteristics of tricuspid valve apparatus with hemodynamic severity of FTR; correlating the severity of FTR with the clinical condition and outcome. Methods The study will be a non-interventional, prospective, international, multicenter, longitudinal study. The minimum number of patients which are expected to be enrolled is 300 HF patients, including HFrEF, HFmrEF and HFpEF patients, whereas 100 PAH patients will serve as control. The patients will be enrolled in 20 centers in Europe, North America and Saudi Arabia. The echocardiographic parameters will be analyzed by the local investigators; a quality control committee will evaluate all data entered in the database to identify potential outliers and a random sample of 10% of cases will be blindly re-analysed in a central core-lab. Conclusions This study has been designed to improve our understanding of pathophysiological mechanisms and clinical relevance of FTR across all HF phenotypes. The results could potentially allow a more appropriate selection of heart failure patients with FTR for tricuspid valve intervention by percutaneous or surgical repair or replacement.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Different heart failure phenotypes of valvular heart disease: the role of mitochondrial dysfunction.
Zhang S, Liu C, Zhang Y, Wu Z, et al · · 2023 · cited 9× · PMID 37273869 · DOI 10.3389/fcvm.2023.1135938 -
Echocardiographic assessment and clinical implication of functional tricuspid regurgitation in heart failure with reduced or preserved ejection fraction (ECLIPSE-HF) : Rationale and design of the study.
Ghio S, Bossone E, Mercurio V, Rudski L, et al · · 2022 · cited 2× · PMID 36445668 · DOI 10.1007/s10554-022-02599-8
Verify or expand the search:
- PubMed search for NCT05209919
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05209919 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fondazione IRCCS Policlinico San Matteo di Pavia
- Last refreshed: 27 January 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05209919.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing