Drug Compliance and Quality of Life in Patients With Heart Failure Dosed With Either Once-Daily or Twice-Daily Coreg

Condition(s) targeted: Chronic Heart Failure

Intervention: carvedilol (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Cardiovascular Clinical Studies

Official(s) and/or principal investigator(s):
James E. Udelson, M.D., Principal Investigator, Affiliation: Cardiovascular Clinical Studies, Inc.

The purpose of this study is to compare dosing compliance between study patients taking controlled release carvedilol once a day, and study patients taking immediate release carvedilol (Coreg) twice a day.

Official title: Prospective, Randomized, Controlled Assessment of Once-Daily Controlled Release COREG CR Vs Twice-Daily COREG Immediate Release(IR)on Measures of Compliance and Quality of Life in Patients With Heart Failure and Left Ventricular Systolic Dysfunction

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment

Primary outcome: Dosing compliance: pill taking total taken vs number prescribed

Secondary outcome: quality of life

Detailed description: Study Further Study Details:

Primary outcome: pill-taking compliance (total doses taken versus total doses prescribed)

Expected Total Enrollment: 400 subjects at 56 study sites in the U. S.

Study Start: October 2005

This is a 5-month double-blind treatment study of male and female subjects with stable mild-to-severe chronic heart failure and with left ventricular dysfunction with symptoms of heart failure.

Eligibility:

Must be stable on treatment with Coreg IR at a standard dose: 6. 25, 12. 5, 25 mg twice a day.

Minimum age: 18 Years. Maximum age: 90 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Ability to read English

- Stable symptoms of mild to severe heart failure

- Stable medical regimen for heart failure

- On a stable dose of Coreg for at least 2 months

- LVEF ≤40% within the previous 24 months

Exclusion Criteria:

- Uncorrected obstructive or regurgitant valve disease

- Complex congenital heart disease

- Recent ICD or pacemaker placement

- Recent coronary artery bypass surgery or stroke

- Candidate for heart transplanct within 5 months of study start

- Present or planned use of MAO inhibitors, alfpha-blockers, combined alpha-beta

blockers, any Class I/II anti-arrythmnic agents, (amiodarone may be used if ≤ 200mg/day). Use of intravenous vasodilator/inotropic agents.

The Heart Group, Mobile, Alabama 36608, United States

Radiant Research, Sierra Vista, Arizona 85635, United States

Northern California Medical Associates, Santa Rosa, California 95403, United States

Cardiology Consultants of Orange County, Anaheim, California 92801, United States

Radiant Research, Santa Rosa, California 95405, United States

San Diego Cardiac Center, San Diego, California 34203, United States

Access Clinical Trials, Beverly Hills, California 90210, United States

Cardiovascular Consultants Medical Group, Walnut Creek, California 94598, United States

Cardiovascular Consultants Medical Group, Oakland, California 94609, United States

Heart Center of the Rockies, Fort Collins, Colorado 80528, United States

St. Francis Hospital and Medical Center, Hartford, Connecticut 06105, United States

NextPhase Clinical Trials, Miami, Florida 33126, United States

Charlotte Heart Group Research Center, Port Charlotte, Florida 33952, United States

The Heart and Vascular Institute of Florida, St. Petersburg, Florida 33701, United States

CVMS Research Institute of Augusta, Augusta, Georgia 30901, United States

Georgia Heart Specialists, Covington, Georgia 30014, United States

Cardiac Disease Specialists, Atlanta, Georgia 30309, United States

Idaho Cardiology Associates, Boise, Idaho 83704, United States

North Shore Cardiologists, Bannockburn, Illinois 60015, United States

Illinois Heart and Lung Research Center, Normal, Illinois 61761, United States

Midwest Heart Foundation, Lombard, Illinois 60148, United States

The Care Group, Indianapolis, Indiana 46260, United States

Clinical Trials Management, Metairie, Louisiana 70006, United States

Cardiovascular Consultants of Maine, Scarborough, Maine 04074, United States

Androscoggin Cardiology Associates-Research, Auburn, Maine 04210, United States

Maine Cardiology Associates, S. Portland, Maine 04106, United States

Pentucket Medical Associates, Haverhill, Massachusetts 01830, United States

Primary Care Cardiology Research, Ayer, Massachusetts 01432, United States

Lahey Clinic Cardiology, Burlington, Massachusetts 01805, United States

Henry Ford Hospital, Detroit, Michigan 48202, United States

Bryan LGH Heart Institute, Lincoln, Nebraska 68516, United States

Lovelace Scientific Resources, Las Vegas, Nevada 89128, United States

Associated Cardiovascular Consultants, Cherry Hill, New Jersey 08034, United States

University of New Mexico Health Science Center, Albuquerque, New Mexico 87131, United States

South Bay Cardiovascular Associates, West Islip, New York 11795, United States

Cardiovascular Medical Associates, Garden City, New York 11530, United States

New York University Medical School, New York, New York 10016, United States

MidValley Cardiology, Kingston, New York 12401, United States

Albany Associates in Cardiology, Albany, New York 12205, United States

Alamance Regional Medical Center, Burlington, North Carolina 27215, United States

The Lindner Clinical Trial Center, Cincinnati, Ohio 45219, United States

The Dayton Heart Center, Dayton, Ohio 45414, United States

New Horizons Clinical Research, Cincinnati, Ohio 45242, United States

Akron General Medical Center, Akron, Ohio 44307, United States

North Ohio Research Ltd., Sandusky, Ohio 44870, United States

North Ohio Research Ltd., Lorain, Ohio 44503, United States

Blue Stem Cardiology, Bartlesville, Oklahoma 74006, United States

Cardiovascular Consultants of Oregon, Corvallis, Oregon 97330, United States

Oregon Medical Group Clinical Research, Eugene, Oregon 97401, United States

Guthrie Clinic Ltd., Sayre, Pennsylvania 18840, United States

Rhode Island Heart Failure Center, Providence, Rhode Island 02903, United States

DCOL Center for Clinical Research, Longview, Texas 75605, United States

LDS Hospital Cardiovascular Research, Salt Lake City, Utah 84143, United States

Arrythmia Center for Southern Wisconsin, Elkhorn, Wisconsin 53121, United States

Starting date: October 2005
Last updated: February 6, 2006