Clinical trial NCT03066050: Long Term Follow Up for CTSN Mitral Valve Repair Studies
Official title: Long-Term Follow-Up For Participants Of: Evaluation Of Outcomes Following Mitral Valve Repair/Replacement In SMR and Surgical Interventions For MMR Trials
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Mitral Valve Insufficiency
Coronary Artery Disease
Keywords: Ischemic Mitral Regurgitation
Mitral Valve Disease
Moderate Mitral Regurgitation
Severe Mitral Regurgitation
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: Canadian Institutes of Health Research (CIHR)
First posted: 2017-02-28
Enrollment: 368
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Randomized patients in the MMR and SMR trials who were still alive at 2 years after the index cardiac surgical intervention

Brief summary: This study is a continuation of two previous studies --- the Severe Ischemic Mitral Regurgitation (SMR) Trial (NCT00807040) and the Moderate Ischemic Mitral regurgitation (MMR) Trial (NCT00806988) --- to learn more about patients' health 5-10 years after their mitral valve surgeries. The investigators will collect long-term health information on SMR and MMR trial participants using electronic medical records, patient and/or family input, public records, and healthcare- and vital status-related databases.

Detailed description: This study is a continuation of two CTSN randomized trials --- the Severe Ischemic Mitral Regurgitation (SMR) Trial (NCT00807040) and the Moderate Ischemic Mitral regurgitation (MMR) Trial (NCT00806988) --- for the purpose of assessing the long-term outcomes of the index surgical therapies. Key clinical outcomes will be collected utilizing electronic medical records, patient and/or family input, public records, and healthcare- and vital status-related databases. Extended follow-up data will be obtained on up to 199 SMR and 270 MMR trial participants, who were alive at their 2-year follow-up evaluation. Patients will be followed for a minimum of 5 years and up to 10 years after randomization (the time of index surgical procedure). This follow-up data collection will be conducted by the Cardiothoracic Surgical Trials Network (CTSN) primarily utilizing the minimal PHI necessary to link data obtained from the MMR and SMR trials to other healthcare- and/or vital status-related databases.

Because the design of surgical trials for ischemic mitral regurgitation that would use mortality as a primary endpoint requires the enrollment of thousands of patients, the selected primary endpoint for the CTSN SMR and MMR trials was an echocardiographic measure of left ventricular remodeling. Secondary endpoints included, among others, survival, adverse events, readmissions and costs over a 2-year period. The SMR trial showed no difference in left ventricular reverse remodeling, but the rate of moderate or severe mitral regurgitation recurrence was significantly higher with mitral valve repair, resulting in more heart failure-related adverse events and cardiovascular admissions. Longer-term follow-up will be critical to assess whether this observed trend amongst SMR patients will continue and whether a survival difference will manifest over time. In moderate ischemic mitral regurgitation, mitral valve repair provided a more durable correction of mitral regurgitation than coronary artery bypass grafting (CABG) alone, but repair did not improve survival or reduce overall adverse events or readmissions, and was associated with an early hazard of neurological and supraventricular arrhythmic events. Longer-term follow-up of MMR patients will provide insights into whether the higher degree of recurrent mitral regurgitation with CABG alone will be associated with differences in adverse events, readmissions and survival. Additionally, the benefits of alternative surgical treatments for ischemic mitral regurgitation, which have differential upfront risks and costs, will likely extend beyond 2 years. Cost-effectiveness analysis will delineate the long-term cost-benefit trade-offs between mitral valve repair versus replacement for SMR, and of CABG with repair versus CABG alone for MMR, which should inform surgical decision making, and examine how differences in life expectancy and risk profiles of different patient groups affect cost-effectiveness over time. This extended follow-up should provide important clinical and health policy insights.

Eligibility criteria: Inclusion Criteria:

* Randomized patients in the MMR and SMR trials who were still alive at 2 years after the index cardiac surgical intervention

Exclusion Criteria:

* Patients participating in the MMR and SMR trials who withdrew consent prior to the 2-year follow-up evaluation

Primary outcomes:
measure: Survival
timeFrame: up to 10 years post-surgery (at the time of registry data transfer)
Secondary outcomes:
measure: Repeat Cardiac Interventions for MR
timeFrame: up to 10 years post-surgery (at the time of registry data transfer)
measure: Hospital Costs
timeFrame: up to 10 years post-surgery (at the time of registry data transfer)
measure: Cost Effectiveness
timeFrame: up to 10 years post-surgery (at the time of registry data transfer)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Bethesda
country: United States
facility: Suburban Hospital
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Bronx
country: United States
facility: Montefiore Einstein Heart Center
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Asheville
country: United States
facility: Mission Hospital
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Greenville
country: United States
facility: East Carolina Heart Institute
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Plano
country: United States
facility: Baylor Research Institute
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Health Systems
state: Virginia
city: Falls Church
country: United States
facility: Inova Heart and Vascular Institute
state: Virginia
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Toronto
country: Canada
facility: Sunnybrook Health Science Centre
state: Ontario
city: Toronto
country: Canada
facility: Saint Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal
state: Quebec
city: Montreal
country: Canada
facility: Hôpital du Sacré-Cœur de Montréal
state: Quebec
city: Quebec
country: Canada
facility: Institut Universitaire de Cardiologie de Quebec (Hopital Laval)
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Annetine C Gelijns, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Toronto General Hospital
name: Richard Weisel, MD
role: STUDY_CHAIR
References: