The Long-term Course of Moderate Tricuspid Regurgitation

Completed

• Conditions: Tricuspid Regurgitation; Echocardiography; Heart Failure

• Registration Number: NCT06169345
• Lead Sponsor: IRCCS San Raffaele

Brief Summary

To evaluate the long-term clinical outcome of a cohort of patients suffering from moderate tricuspid regurgitation (TR), regardless of its etiology.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-01
• Primary Completion: 2022-08-01
• Study Completion: 2023-02-01
• Study First Submitted: 2023-09-26
• Status Verified: 2023-12
• Study First Submitted QC: 2023-12-12
• Last Update Submitted: 2023-12-12
• Study First Posted: 2023-12-13
• Last Update Posted: 2023-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

1. Patients with an echocardiographic diagnosis of moderate TR
2. Patients with echocardiographic and clinical follow-up information available at least 6-months after moderateTR diagnosis.

Exclusion Criteria

1. Absence of an appropriate clinical and echocardiographic follow-up
2. A history of previous TV intervention (either surgical or percutaneous)
3. The presence of concomitant TV stenosis
4. Congenital heart disease
5. Left ventricular assist devices

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All-cause death	through study completion, an average of 2 years	Time from diagnosis to all-cause death

Secondary Outcome Measures

Name	Time	Method
Cardiovascular (CV) mortality	through study completion, an average of 2 years	The occurrence of cardiovascular (CV) mortality (defined as death due to advanced heart failure, coronary ischemic heart disease, sudden cardiac death or due to stroke

Trial Locations

Locations (1)

Irccs San Raffaele; 🇮🇹 Milan, Italy