Comparison of Surgical and Medical Treatment for Congestive Heart Failure and Coronary Artery Disease
Condition: Cardiovascular Diseases; Coronary Disease; Heart Failure, Congestive; Heart Diseases
MeSH terms: Heart Failure; Cardiovascular Diseases; Heart Diseases; Coronary Disease
Intervention: CABG surgery plus MED; Active Medication Alone; CABG plus MED and SVR
Intervention description: CABG plus standard medication management for Coronary Artery Disease; Standard medication for coronary artery disease and heart failure management.; H02: the experimental arm receives active medical therapy and CABG and surgical ventricular restoration whereas the control group receives active medical therapy and CABG; for H01: the experimental arm receives active medical therapy and CABG whereas the control group receives active medical therapy alone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 2136.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No

Summary:

      This study will compare medical therapy with coronary bypass surgery and/or surgical
      ventricular reconstruction for patients with congestive heart failure and coronary artery
      disease (CAD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  LV less than 35%, as defined by echocardiogram, left ventriculogram, CMR, or gated
             single photon emission computed tomography (SPECT) studies

          -  Coronary anatomy suitable for revascularization

        Exclusion Criteria:

          -  Failure to provide informed consent.

          -  Aortic valvular heart disease clearly indicating the need for aortic valve repair or
             replacement.

          -  Cardiogenic shock (within 72 hours of randomization), as defined by the need for
             intraaortic balloon support or the requirement for intravenous inotropic support.

          -  Plan for percutaneous intervention of CAD.

          -  Recent acute MI judged to be an important cause of left ventricular dysfunction.

          -  History of more than 1 prior coronary bypass operation.

          -  Noncardiac illness with a life expectancy of less than 3 years.

          -  Noncardiac illness imposing substantial operative mortality.

          -  Conditions/circumstances likely to lead to poor treatment adherence (eg, history of
             poor compliance, alcohol or drug dependency, psychiatric illness, no fixed abode).

          -  Previous heart, kidney, liver, or lung transplantation.

          -  Current participation in another clinical trial in which a patient is taking an
             investigational drug or receiving an investigational medical device.

        MED Therapy Eligibility Criteria

          -  Absence of left main CAD as defined by an intraluminal stenosis of 50% or greater.

          -  Absence of CCS III angina or greater (angina markedly limiting ordinary activity).

        SVR Eligibility Criterion

        • Dominant akinesia or dyskinesia of the anterior left ventricular wall amenable to SVR.