Echocardiographic Assessment and CLInical imPlication of Functional tricuSpid rEgurgitation in Heart Failure With Reduced or Preserved Ejection Fraction

Recruiting

• Conditions: Functional Tricuspid Regurgitation
• Interventions: Diagnostic Test: Transthoracic Echocardiography

• Registration Number: NCT05209919
• Lead Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia

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

Not available

Study Timeline

• Study Start: 2021-11-11
• Study First Submitted: 2021-12-17
• Status Verified: 2022-01
• Study First Submitted QC: 2022-01-22
• Last Update Submitted: 2022-01-22
• Study First Posted: 2022-01-27
• Last Update Posted: 2022-01-27
• Primary Completion: 2023-12-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• consecutive consenting outpatients with HFrEF, HFmrHF, HFpEF or PAH,
• ambulatory visit routinely planned with an echocardiographic examination,
• at the time of the visit at least moderate FTR diagnosed at echocardiography (by visual assessment),
• aged ≥ 18 years old,
• capable to sign an informed consent.

Exclusion Criteria

• age < 18 years old,
• congenital heart disease,
• heart failure due to organic mitral or aortic valve disease. No examination will be performed in addition to what is routinely planned for patients' evaluation.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HFpEF	Transthoracic Echocardiography	All patients with HFpEF and significant functional tricuspid regurgitation
Pulmonary arterial hypertension	Transthoracic Echocardiography	All patients with pulmonary arterial hypertension and significant functional tricuspid regurgitation
HFrEF	Transthoracic Echocardiography	All patients with HFrEF and significant functional tricuspid regurgitation
Heart Failure mildly-reduced ejection fraction	Transthoracic Echocardiography	All patients with Heart Failure mildly-reduced ejection fraction and significant functional tricuspid regurgitation

Primary Outcome Measures

Name	Time	Method
Time to all-cause death or to first HF hospitalization	12 months

Trial Locations

Locations (1)

Foundation IRCCS SanMatteo Hospital; 🇮🇹 Pavia, PV, Italy