Comparison of Surgical and Medical Treatment for Congestive Heart Failure and Coronary Artery Disease

• Status: Completed
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)

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.