The Long-term Course of Moderate Tricuspid Regurgitation | NCT06169345

Studies
The Long-term Course of Moderate Tricuspid Regurgitation

NCT06169345

Sponsor

IRCCS San Raffaele

Status

Completed

Last Update Posted

Dec 13, 2023Actual

Enrollment

250Actual

Phase

Not provided

Conditions

Tricuspid Regurgitation
Heart Failure
Echocardiography

Interventions

Echocardiographic evaluation

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2021Actual

Primary Completion Date

Aug 1, 2022Actual

Completion Date

Feb 1, 2023Actual

First Submitted Date

Sep 26, 2023

First Submission Date that Met QC Criteria

Dec 12, 2023

First Posted Date

Dec 13, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 12, 2023

Last Update Posted Date

Dec 13, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Agricola Eustachio, Director of Cardiovascular Imaging Department, IRCCS San RaffaelePrincipal Investigator

Lead Sponsor

IRCCS San RaffaeleOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

250Actual

Name	Type	Description	Arm Group Labels	Other Names
Echocardiographic evaluation	Other	Echocardiographic follow-up

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
All-cause death	Time from diagnosis to all-cause death	through study completion, an average of 2 years

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

95 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with an echocardiographic diagnosis of moderate tricuspid regurgitation at our center between 2010 and 2019

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Irccs San Raffaele		Milan		20900	Italy

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014262	Tricuspid Valve Insufficiency
D006333	Heart Failure

Ancestor Terms

ID	Term
D006349	Heart Valve Diseases
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided