The Long-term Course of Moderate Tricuspid Regurgitation

Heart Failure Clinical Trial

— LOCOMOTRI  

Official title:

The Long-term Clinical Course of Moderate Tricuspid Regurgitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06169345
• Other study ID #: LOCOMOTRI STUDY
• Status: Completed
• Start date: May 1, 2021
• Est. completion date: February 1, 2023

Study information

• Verified date: December 2023
• Source: IRCCS San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: February 1, 2023
• Est. primary completion date: August 1, 2022
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Echocardiography
• Heart Failure
• Tricuspid Regurgitation
• Tricuspid Valve Insufficiency

Intervention

Other:
• Echocardiographic evaluation
Echocardiographic follow-up

Locations

Country	Name	City	State
Italy	Irccs San Raffaele	Milan

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause death	Time from diagnosis to all-cause death	through study completion, an average of 2 years
Secondary	Cardiovascular (CV) mortality	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	through study completion, an average of 2 years