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

NCT00023595 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2136

Last updated 2019-09-19

Study results available
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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).

Conditions

Interventions

PROCEDURE

CABG surgery plus MED

CABG plus standard medication management for Coronary Artery Disease

DRUG

Active Medication Alone

Standard medication for coronary artery disease and heart failure management.

PROCEDURE

CABG plus MED and SVR

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

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH
  • Duke University

    lead OTHER

Principal Investigators

  • Robert Bonow · Radionuclide Core Lab, Northwestern University

  • Arthur Feldman · Neurohormonal Core Lab, Jefferson University

  • Eric Velazquez, MD · Clinical Coordinating Center, Duke University

  • Kerry Lee · Data Coordinating Center, Duke University

  • Daniel Mark · Economics and Quality of Life Core Lab, Duke University

  • Jae Oh · Echocardiographic Core Lab, Mayo Clinic

  • Gerald Pohost · Magnetic Resonance Imaging Core Lab, University of Southern California

  • Jean Rouleau · Université de Montréal

  • Julio A Panza, MD · Medstar Health Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-01-31
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00023595 on ClinicalTrials.gov