Skip to main content
OpenTrials
Completed

NCT Number: NCT01502462

Prospective Registry of Patients With Isolated Severe Tricuspid Regurgitation

Prospective registry for patients with severe isolated tricuspid regurgitation (TR) without significant left-sided valvular or myocardial diseases.

Aim: To evaluate clinical course and prognostic factors of patients with severe isolated TR.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Tricuspid Regurgitation Cardiovascular Diseases Disease Attributes Disease Progression Heart Diseases Heart Valve Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tricuspid Valve Insufficiency

Age range

16 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Asan Medical Center

Seoul, 138-736, South Korea

About this study

Inclusion criteria

Severe isolated TR for more than 6 months

Exclusion criteria

  • Severe mitral and aortic valvular heart disease
  • Age equals to or more than 75 years
  • Malignancy or serious comorbidity with life expectancy < 5years
  • Acute or subacute infective endocarditis requiring antibiotics therapy
  • Untreated hyperthyroidism
  • Constrictive pericarditis
  • Unclosed significant atrial septal defect
  • Previous tricuspid valve surgery
  • Significant coronary artery disease
  • Cardiomyopathy
  • Pregnancy
  • Severe resting pulmonary hypertension(TR Vmax >4.0 m/s)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Severe isolated TR for more than 6 months

Exclusion criteria

  • Severe mitral and aortic valvular heart disease
  • Age equals to or more than 75 years
  • Malignancy or serious comorbidity with life expectancy < 5years
  • Acute or subacute infective endocarditis requiring antibiotics therapy
  • Untreated hyperthyroidism
  • Constrictive pericarditis
  • Unclosed significant atrial septal defect
  • Previous tricuspid valve surgery
  • Significant coronary artery disease
  • Cardiomyopathy
  • Pregnancy
  • Severe resting pulmonary hypertension(TR Vmax >4.0 m/s)

Treatment and study plan

Primary outcomes

  1. all cause death

    Time frame: 5 years

Secondary outcomes

  1. Hospitalization of cardiovascular causes

    Time frame: 5 years

  2. tricuspid valve surgery

    Time frame: 5 years

  3. stroke

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Important dates

Study start
2012
Primary completion
2020
Study completion
2020
First posted
Dec 30, 2011
Registry last updated
Feb 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.