Ignite Creation Date:
2024-05-06 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 2:23 PM
Study NCT ID:
NCT05209919
Status:
RECRUITING
Last Update Posted:
2022-01-27
First Post:
2021-12-17
Brief Title:
Echocardiographic Assessment and CLInical imPlication of Functional tricuSpid rEgurgitation in Heart Failure With Reduced or Preserved Ejection Fraction
Sponsor:
Fondazione IRCCS Policlinico San Matteo di Pavia
Organization:
Fondazione IRCCS Policlinico San Matteo di Pavia
Study Overview
Official Title:
Echocardiographic Assessment and CLInical imPlication of Functional tricuSpid rEgurgitation in Heart Failure With Reduced or Preserved Ejection Fraction ECLIPSE-HF
Status:
RECRUITING
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ECLIPSE-HF
Brief Summary:
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None