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Prospective Registry of Patients With Isolated Severe Tricuspid Regurgitation

This study is currently recruiting participants.
Verified July 2016 by Jong-Min Song, Asan Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT01502462
First Posted: December 30, 2011
Last Update Posted: July 13, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Jong-Min Song, Asan Medical Center
  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 Jong-Min Song, Asan Medical Center:

Primary Outcome Measures:
  • all cause death [ Time Frame: 5 years ]

Secondary Outcome Measures:
  • Hospitalization of cardiovascular causes [ Time Frame: 5 years ]
  • tricuspid valve surgery [ Time Frame: 5 years ]
  • stroke [ Time Frame: 5 years ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Jong-Min Song, Associate professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01502462     History of Changes
Other Study ID Numbers: Severe_Isol_TR
First Submitted: December 29, 2011
First Posted: December 30, 2011
Last Update Posted: July 13, 2016
Last Verified: July 2016

Keywords provided by Jong-Min Song, Asan Medical Center:
Clinical course and prognostic factors in patients with severe isolated TR

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