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

Completed · Phase 3

Conditions studied: Cardiovascular Diseases, Coronary Disease, Heart Failure, Congestive, Heart Diseases

In brief

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).

Key facts

Study ID

NCT00023595

Run by

Duke University

People needed

2136

Starts

2002-01-01

Expected to finish

2015-11-01

Last updated by the study team

2019-09-19

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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