Long Term Follow Up for CTSN Mitral Valve Repair Studies

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03066050
• Other study ID #: GCO 08-1078-00012
• Secondary ID: U01HL088942
• Status: Active, not recruiting
• Start date: May 3, 2017
• Est. completion date: May 2024

Study information

• Verified date: June 2023
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 368
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Mitral Valve Insufficiency

Intervention

Other:
• MV Repair
Participants underwent mitral valve repair with annuloplasty and a sub-valvular procedure for severe tethering.
• MV Replacement
Participants underwent mitral valve replacement and complete preservation of the sub-valvular apparatus.
• CABG
Participants underwent coronary artery bypass grafting

Locations

Country	Name	City	State
Canada	University of Alberta Hospital	Edmonton	Alberta
Canada	Centre Hospitalier de l'Université de Montréal	Montreal	Quebec
Canada	Hôpital du Sacré-Cœur de Montréal	Montreal	Quebec
Canada	Montreal Heart Institute	Montreal	Quebec
Canada	Institut Universitaire de Cardiologie de Quebec (Hopital Laval)	Quebec
Canada	Saint Michael's Hospital	Toronto	Ontario
Canada	Sunnybrook Health Science Centre	Toronto	Ontario
Canada	Toronto General Hospital	Toronto	Ontario
United States	Mission Hospital	Asheville	North Carolina
United States	Emory University	Atlanta	Georgia
United States	University of Maryland	Baltimore	Maryland
United States	Suburban Hospital	Bethesda	Maryland
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Montefiore Einstein Heart Center	Bronx	New York
United States	University of Virginia Health Systems	Charlottesville	Virginia
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Ohio State University	Columbus	Ohio
United States	Duke University	Durham	North Carolina
United States	Inova Heart and Vascular Institute	Falls Church	Virginia
United States	East Carolina Heart Institute	Greenville	North Carolina
United States	University of Southern California	Los Angeles	California
United States	Columbia University Medical Center	New York	New York
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Baylor Research Institute	Plano	Texas

Sponsors (3)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	Canadian Institutes of Health Research (CIHR), National Heart, Lung, and Blood Institute (NHLBI)

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival	All-cause mortality will be assessed.	up to 10 years post-surgery (at the time of registry data transfer)
Secondary	Repeat Cardiac Interventions for MR	Repeat cardiac interventions for MR in particular will be determined for the duration of follow-up and will be analyzed using a time-to-event analysis.	up to 10 years post-surgery (at the time of registry data transfer)
Secondary	Hospital Costs	Hospital costs will be calculated for the duration of follow-up utilizing the minimum PHI necessary to link the CTSN databases to other databases (e.g., Vizient, CMS Medicare, and Canadian Province databases). Cost data will be extracted from the Vizient operational database system for member sites or national payer or state-wide databases. Dates of charges and revenue codes will be used to match the cost data with data on readmissions. We will estimate costs including center-specific ratios of cost to charges. These ratios will be based on the annual Medicare costs reports submitted annually by participating study sites to Medicare. These data will be used to impute data for patients treated at hospitals, which are non-Vizient members.	up to 10 years post-surgery (at the time of registry data transfer)
Secondary	Cost Effectiveness	Cost Effectiveness using Incremental Cost Effectiveness Ratio and Net Health Benefit parameters. The primary objective of the cost-effectiveness analysis (CEA) is to estimate the incremental cost-effectiveness ratio (ICER) of the intervention under investigation as compared to the study-defined alternative. This ratio measures the ratio of the difference in costs and outcomes between the two study arms for each trial, with outcomes measured as life-years. We will also compute net health benefits (NHB) as an alternative way of looking at cost-effectiveness. This parameter compares the incremental effectiveness of an intervention with the minimum health effect that society would demand in return for the investment; i.e., with the health produced by investing at the societal ceiling cost-effectiveness ratio.	up to 10 years post-surgery (at the time of registry data transfer)