Prospective Registry of Patients With Isolated Severe Tricuspid Regurgitation

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Asan Medical Center
Sponsor:
Information provided by (Responsible Party):
Jong-Min Song, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01502462
First received: December 29, 2011
Last updated: March 19, 2014
Last verified: March 2014
  Purpose

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.


Condition
Tricuspid Regurgitation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • all cause death [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Hospitalization of cardiovascular causes [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • tricuspid valve surgery [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • stroke [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: February 2012
Estimated Study Completion Date: January 2022
Estimated Primary Completion Date: January 2022 (Final data collection date for primary outcome measure)
Detailed Description:

Inclusion criteria Severe isolated TR for more than 6 months

Exclusion criteria

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

Ages Eligible for Study:   16 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

Inclusion criteria

  • Severe isolated TR for more than 6 months

Exclusion criteria

  1. Severe mitral and aortic valvular heart disease
  2. Age equals to or more than 75 years
  3. Malignancy or serious comorbidity with life expectancy < 5years
  4. Acute or subacute infective endocarditis requiring antibiotics therapy
  5. Untreated hyperthyroidism
  6. Constrictive pericarditis
  7. Unclosed significant atrial septal defect
  8. Previous tricuspid valve surgery
  9. Significant coronary artery disease
  10. Cardiomyopathy
  11. Pregnancy
  12. Severe resting pulmonary hypertension(TR Vmax >4.0 m/s)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01502462

Locations
Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Jong-Min Song, MD, PhD    82-2-3010-3168    jmsong@amc.seoul.kr   
Principal Investigator: Jong-Min Song, MD, PhD         
Sponsors and Collaborators
Asan Medical Center
  More Information

No publications provided

Responsible Party: Jong-Min Song, Associate professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01502462     History of Changes
Other Study ID Numbers: Severe_Isol_TR
Study First Received: December 29, 2011
Last Updated: March 19, 2014
Health Authority: South Korea: Institutional Review Board

Keywords provided by Asan Medical Center:
Clinical course and prognostic factors in patients with severe isolated TR

Additional relevant MeSH terms:
Tricuspid Valve Insufficiency
Cardiovascular Diseases
Heart Diseases
Heart Valve Diseases

ClinicalTrials.gov processed this record on October 21, 2014