Early Surgery Versus Conventional Treatment for Asymptomatic Severe Mitral Regurgitation

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Asan Medical Center
Sponsor:
Information provided by (Responsible Party):
Duk-Hyun Kang, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01703806
First received: October 8, 2012
Last updated: May 20, 2014
Last verified: May 2014
  Purpose

The timing of surgical intervention in asymptomatic patients with severe degenerative mitral regurgitation (MR) remains controversial. The benefit of early surgery has been suggested in prospective, observational studies, whereas a watchful waiting strategy seemed to be safe and effective in the other prospective study. The consensus guidelines for the performance of early surgery in asymptomatic patients with severe MR are different, reflecting controversy. Clinical outcome in asymptomatic patients with MR is poorly defined and it is important to identify high-risk patients in whom early surgery may be warranted. Thus, the investigators try to compare long-term outcomes of early surgery with those of a conventional-treatment strategy in a large prospective cohort of asymptomatic patients with severe degenerative MR using a propensity analysis, and to identify high-risk subgroups to whom early surgery is more beneficial.


Condition
Mitral Regurgitation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Early Surgery Versus Conventional Treatment for Asymptomatic Patients With Severe Degenerative Mitral Regurgitation: A Propensity Analysis

Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • Cardiac mortality [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
    Cardiac mortality is defined as operative mortality, sudden cardiac death, death from complications of myocardial infarction, heart failure, complications of cardiac intervention or other cardiac disease. Operative mortality is defined as death within 30 days of mitral valve surgery.


Secondary Outcome Measures:
  • Repeat mitral valve surgery [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
  • Hospitalization due to congestive heart failure [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
    A congestive heart failure hospitalization is defined as an unplanned, urgent admission for the management of congestive heart failure . A patient admitted for congestive heart failure have to show resting dyspnea and radiological signs of pulmonary edema and require intravenous diuretics.

  • A composite of cardiac events [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
    A composite of cardiac mortality, repeat MV surgery and hospitalization due to congestive heart failure during follow-up.


Estimated Enrollment: 600
Study Start Date: December 2007
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Mitral regurgitation
Asymptomatic patients with severe degenerative mitral regurgitation

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

From 2007 to 2016, 600 consecutive, asymptomatic patients with severe degenerative MR who are potential candidates for early surgery, will be enrolled in the present study. Severe degenerative MR is defined as severe prolapse and/or flail leaflet of the mitral valve with a proximal isovelocity surface area (PISA) radius > 8 mm.

Criteria

Inclusion Criteria:

  • asymptomatic patients
  • severe degenerative MR
  • preserved left ventricular systolic function

Exclusion Criteria: According to the recommendations of the 2006 American College of Cardiology/American Heart Association (ACC/AHA) guidelines for surgical indications of severe MR, the criteria for exclusion from the study are defined as follows.

  • patients with the presence of exertional dyspnea, or angina
  • left ventricular ejection fraction < 0.60
  • left ventricular end-systolic dimension > 40 mm
  • atrial fibrillation
  • significant aortic valve disease
  • Doppler-estimated systolic pulmonary artery pressure > 50 mmHg
  • patients who were not candidates for early surgery based on age > 80 years and coexisting malignancies
  • patients who did not consent to participate
  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: NCT01703806

Contacts
Contact: Duk-Hyun Kang, MD, PhD 82-2-3010-3166 dhkang@amc.seoul.kr
Contact: Dae-Hee Kim, MD, PhD 82-2-3010-3151 daehee74@amc.seoul.kr

Locations
Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Duk-Hyun Kang, MD, PhD    82-2-3010-3166    dhkang@amc.seoul.kr   
Principal Investigator: Duk-Hyun Kang, MD, PhD         
Sponsors and Collaborators
Asan Medical Center
Investigators
Principal Investigator: Duk-Hyun Kang, MD, PhD Asan Medical Center
  More Information

Publications:
Responsible Party: Duk-Hyun Kang, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01703806     History of Changes
Other Study ID Numbers: 2007-0264
Study First Received: October 8, 2012
Last Updated: May 20, 2014
Health Authority: Korea: Food and Drug Administration

Keywords provided by Asan Medical Center:
Mitral regurgitation
Mitral valve repair
Watchful waiting

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

ClinicalTrials.gov processed this record on August 27, 2014