A Study to Compare the Effects of Coreg CR and Coreg IR on Heart Function in Subjects With Stable Chronic Heart Failure

NCT00323037 | Completed Phase 3 Results

• 1 other identifier: 104852
• Study Type: interventional
• Target: 318
• Locations: 1 country
• Sites: 75

Brief Summary

The purpose of this study is to determine if Coreg CR is as effective as Coreg IR in improving heart function in subjects with stable chronic heart failure.

Conditions

Congestive Heart Failure

Keywords

heart failure

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Left Ventricular End Systolic Volume Index (LVESVI) Characterized by 2-D Echocardiography

  Maintenance Visit 3 minus Baseline. Maintenance Visit 3 occurred 24 weeks after entry into the maintenance period. The maintenance period started after completion of a titration period of variable duration.

  24 weeks after entry into the maintenance period

Secondary Outcomes (16)

• Change From Baseline in Left Ventricular Ejection Fraction (LVEF)

  24 weeks after entry into the maintenance period

• Change From Baseline in Left Ventricular End Diastolic Volume (LVEDV)

  24 weeks after entry into the maintenance period

• Change From Baseline in Left Ventricular End Systolic Volume (LVESV)

  24 weeks after entry into the maintenance period

• Change From Baseline in Left Ventricular End Diastolic Volume Index (LVEDVI)

  24 weeks after entry into the maintenance period

• Change From Baseline in Intraventricular Septal Thickness (IVST)

  24 weeks after entry into the maintenance period

Study Arms (2)

1

ACTIVE COMPARATOR

Drug: carvedilol immediate release

2

ACTIVE COMPARATOR

Drug: carvedilol controlled release

Interventions

carvedilol controlled release DRUG

Carvedilol controlled release (10, 20, 40 or 80 mg) and placebo taken in the morning. Two placebos taken in the evening. A total of 4 pills will be taken PO daily.

Also known as: Coreg CR

2

carvedilol immediate release DRUG

Carvedilol immediate release (3.125, 6.25, 12.5 or 25 mg) and placebo, taken PO, twice-daily.

Also known as: Coreg, Coreg IR

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or non-pregnant female
• At least 18 years of age at the time informed consent is signed
• Stable, chronic, mild to severe heart failure as defined as subjects with symptoms of heart failure who do not require IV diuretics, inotropes, or vasodilators or those that require support with a left ventricular assist device
• Angiotensin converting enzyme inhibitors or angiotensin receptor blockers should be prescribed to all patients with HF due to LV systolic dysfunction with reduced LVEF unless contraindicated or intolerant to use
• At screening, subject has an LVEF \< 40 as measured by 2-D echocardiography
• Willing to provide written informed consent

You may not qualify if:

• On beta-blocker therapy for greater than 42 days prior to consent
• Acute ischemic coronary event or coronary revascularization (PTCA, CABG, thrombolysis) within 1 week of screening echocardiography
• Scheduled or expected to be scheduled coronary revascularization within 4 weeks
• Unstable angina (angina characterized by sudden changes in the severity or length of angina attacks or a decrease in level of exertion that precipitates an episode
• Uncorrected primary obstructive or severe regurgitant valvular disease, nondilated (restrictive) or hypertrophic cardiomyopathies
• Uncontrolled ventricular arrhythmias (symptomatic or sustained ventricular arrhythmias not controlled with antiarrhythmic therapy or an implantable defibrillator)
• Current treatment of calcium channel blockers except for long acting dihydropyridines
• Current treatment on any Class I or III antiarrhythmic, except amiodarone
• History of sick sinus syndrome unless a pacemaker is in place
• Second or third degree heart block unless a pacemaker is in place
• Current clinical evidence of obstructive pulmonary disease (e.g., asthma or bronchitis) requiring inhaled or oral bronchodilator or steroid therapy; or having a history of bronchospastic disease not undergoing active therapy in whom, in the investigator's opinion, treatment with study medication could provoke bronchospasm
• Expected biventricular pacemaker placement within 8 months of enrollment
• Resting systolic blood pressure \<90 mmHg (based on the average of 3 readings
• Resting heart rate \<50 beats per minute (bpm) (based on the average of 3 readings)
• Current decompensated heart failure

Sponsors & Collaborators

• CTI-1, LLC: lead
• CTI Clinical Trial and Consulting Services: collaborator
• GlaxoSmithKline: collaborator

Study Sites (75)

Cardiology Associates

Mobile, Alabama, 36608, United States

Location

Mobile Heart Specialists

Mobile, Alabama, 36608, United States

Location

Mayo Clinic Arizona

Phoenix, Arizona, 85054, United States

Location

Scottsdale Cardiovascular Research Institute

Scottsdale, Arizona, 85251, United States

Location

South West Heart

Tucson, Arizona, 85715, United States

Location

Inland Heart Doctors Medical Group

Corona, California, 92879, United States

Location

Rancho Los Amigos USC

Downey, California, 90242, United States

Location

William Bowden, DO Private Practice

Healdsburg, California, 95448, United States

Location

Merced Heart Associates

Merced, California, 95340, United States

Location

Sutter Memorial Hospital

Sacramento, California, 95819, United States

Location

Southern California Cardiology Medical Group, Inc.

San Diego, California, 92120, United States

Location

Medvin Clinical Research

Van Nuys, California, 91405, United States

Location

Aurora Denver Cardiology Associates

Denver, Colorado, 80218, United States

Location

Medical Center of the Rockies Foundation

Loveland, Colorado, 80538, United States

Location

Bay Area Cardiology

Brandon, Florida, 33511, United States

Location

Clearwater Cardiovascular and Interventional Consultants

Clearwater, Florida, 33756, United States

Location

White-Wilson Medical Center, PA

Fort Walton Beach, Florida, 32547, United States

Location

South Florida International Cardiology Consultants, Inc.

Miami, Florida, 33137-3732, United States

Location

Palm Beach Cardiology

Palm Beach Gardens, Florida, 33410, United States

Location

Cardiac Disease Specialists, PC

Atlanta, Georgia, 30309, United States

Location

Harbin Clinic

Rome, Georgia, 30165, United States

Location

North Shore Cardiovascular Research Consortium

Bannockburn, Illinois, 60015, United States

Location

Saint Francis Hospital

Evanston, Illinois, 60202, United States

Location

Illinois Heart and Vascular

Hinsdale, Illinois, 60521, United States

Location

HeartCare Midwest

Peoria, Illinois, 61614, United States

Location

Rockford Cardiology Research Foundation

Rockford, Illinois, 61107, United States

Location

Prairie Cardiovascular Consultants

Springfield, Illinois, 62701, United States

Location

The Care Group LLC

Indianapolis, Indiana, 46260, United States

Location

River Cities Cardiology

Jeffersonville, Indiana, 47130, United States

Location

Iowa Heart Center

West Des Moines, Iowa, 50266, United States

Location

Mid-America Cardiology

Kansas City, Kansas, 66160, United States

Location

Via Christi Research, Inc.

Wichita, Kansas, 67214, United States

Location

Comprehensive Cardiology Associates

Florence, Kentucky, 41042, United States

Location

Cardiovascular Associates

Louisville, Kentucky, 40205, United States

Location

Louisville Cardiology Medical Group

Louisville, Kentucky, 40207, United States

Location

One Heart, LLC

Baltimore, Maryland, 21215, United States

Location

Minnesota Heart Clinic

Edina, Minnesota, 55435, United States

Location

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

Regions Hospital Cardiology Research

Saint Paul, Minnesota, 55101, United States

Location

St. Paul Cardiology

Saint Paul, Minnesota, 55102, United States

Location

Cardiology Associates Research, LLC

Tupelo, Mississippi, 38801, United States

Location

Rocky Mountain Heart & Lung

Kalispell, Montana, 59901, United States

Location

Diagnostic and Clinical Cardiology

West Orange, New Jersey, 07052, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87131-0001, United States

Location

Albany Associates in Cardiology

Albany, New York, 12205, United States

Location

Buffalo Heart Group, LLP

Buffalo, New York, 14215, United States

Location

Long Island Heart Associates

Mineola, New York, 11501, United States

Location

New York Cardiovascular Associates

New York, New York, 10035, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

South Bay Cardiovascular Associates

West Islip, New York, 11795, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

LeBauer Cardiovascular Research Foundation

Greensboro, North Carolina, 27401, United States

Location

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

Sterling Research Group Ltd.

Cincinnati, Ohio, 45219, United States

Location

The Lindner Clinical Trial Center

Cincinnati, Ohio, 45219, United States

Location

University Hospital

Cincinnati, Ohio, 45267-0542, United States

Location

Northwest Ohio Cardiology Consultants

Toledo, Ohio, 43615, United States

Location

Oklahoma Cardiovascular Research Group

Oklahoma City, Oklahoma, 73120, United States

Location

Samaritan Cardiology

Corvallis, Oregon, 97330, United States

Location

Blair Medical Associates

Altoona, Pennsylvania, 16602, United States

Location

Tri-State Medical Group

Beaver, Pennsylvania, 15009, United States

Location

Central Bucks Specialists

Doylestown, Pennsylvania, 18901, United States

Location

Cardiology Consultants of Philadelphia

Philadelphia, Pennsylvania, 19148, United States

Location

Mid State Medical Service

Philipsburg, Pennsylvania, 16866, United States

Location

Buxmont Cardiology Associates, PC

Sellersville, Pennsylvania, 18960, United States

Location

Rhode Island Heart Failure Center

Providence, Rhode Island, 02903, United States

Location

Charleston Cardiology

Charleston, South Carolina, 29403, United States

Location

South Carolina Heart Center

Columbia, South Carolina, 29204, United States

Location

Heart Specialists

Friendswood, Texas, 77546, United States

Location

Texas Cardiac Center

Lubbock, Texas, 79410, United States

Location

Intermountain Medical Center

Murray, Utah, 84107, United States

Location

Heart Center

Salt Lake City, Utah, 84124, United States

Location

Winchester Medical Center

Winchester, Virginia, 22601, United States

Location

Luther Midelfort Mayo Health Systems

Eau Claire, Wisconsin, 54702, United States

Location

Green Bay HeartCare

Green Bay, Wisconsin, 54303, United States

Location

Related Publications (13)

• Effect of metoprolol CR/XL in chronic heart failure: Metoprolol CR/XL Randomised Intervention Trial in Congestive Heart Failure (MERIT-HF). Lancet. 1999 Jun 12;353(9169):2001-7.

  PMID: 10376614 BACKGROUND

• The Cardiac Insufficiency Bisoprolol Study II (CIBIS-II): a randomised trial. Lancet. 1999 Jan 2;353(9146):9-13.

  PMID: 10023943 BACKGROUND

• Packer M, Colucci WS, Sackner-Bernstein JD, Liang CS, Goldscher DA, Freeman I, Kukin ML, Kinhal V, Udelson JE, Klapholz M, Gottlieb SS, Pearle D, Cody RJ, Gregory JJ, Kantrowitz NE, LeJemtel TH, Young ST, Lukas MA, Shusterman NH. Double-blind, placebo-controlled study of the effects of carvedilol in patients with moderate to severe heart failure. The PRECISE Trial. Prospective Randomized Evaluation of Carvedilol on Symptoms and Exercise. Circulation. 1996 Dec 1;94(11):2793-9. doi: 10.1161/01.cir.94.11.2793.

  PMID: 8941104 BACKGROUND

• Packer M, Bristow MR, Cohn JN, Colucci WS, Fowler MB, Gilbert EM, Shusterman NH. The effect of carvedilol on morbidity and mortality in patients with chronic heart failure. U.S. Carvedilol Heart Failure Study Group. N Engl J Med. 1996 May 23;334(21):1349-55. doi: 10.1056/NEJM199605233342101.

  PMID: 8614419 BACKGROUND

• Colucci WS, Packer M, Bristow MR, Gilbert EM, Cohn JN, Fowler MB, Krueger SK, Hershberger R, Uretsky BF, Bowers JA, Sackner-Bernstein JD, Young ST, Holcslaw TL, Lukas MA. Carvedilol inhibits clinical progression in patients with mild symptoms of heart failure. US Carvedilol Heart Failure Study Group. Circulation. 1996 Dec 1;94(11):2800-6. doi: 10.1161/01.cir.94.11.2800.

  PMID: 8941105 BACKGROUND

• Cohn JN, Fowler MB, Bristow MR, Colucci WS, Gilbert EM, Kinhal V, Krueger SK, Lejemtel T, Narahara KA, Packer M, Young ST, Holcslaw TL, Lukas MA. Safety and efficacy of carvedilol in severe heart failure. The U.S. Carvedilol Heart Failure Study Group. J Card Fail. 1997 Sep;3(3):173-9. doi: 10.1016/s1071-9164(97)90013-0.

  PMID: 9330125 BACKGROUND

• Olsen SL, Gilbert EM, Renlund DG, Taylor DO, Yanowitz FD, Bristow MR. Carvedilol improves left ventricular function and symptoms in chronic heart failure: a double-blind randomized study. J Am Coll Cardiol. 1995 May;25(6):1225-31. doi: 10.1016/0735-1097(95)00012-S.

  PMID: 7722114 BACKGROUND

• Randomised, placebo-controlled trial of carvedilol in patients with congestive heart failure due to ischaemic heart disease. Australia/New Zealand Heart Failure Research Collaborative Group. Lancet. 1997 Feb 8;349(9049):375-80.

  PMID: 9033462 BACKGROUND

• Bristow MR, Gilbert EM, Abraham WT, Adams KF, Fowler MB, Hershberger RE, Kubo SH, Narahara KA, Ingersoll H, Krueger S, Young S, Shusterman N. Carvedilol produces dose-related improvements in left ventricular function and survival in subjects with chronic heart failure. MOCHA Investigators. Circulation. 1996 Dec 1;94(11):2807-16. doi: 10.1161/01.cir.94.11.2807.

  PMID: 8941106 BACKGROUND

• Dargie HJ. Effect of carvedilol on outcome after myocardial infarction in patients with left-ventricular dysfunction: the CAPRICORN randomised trial. Lancet. 2001 May 5;357(9266):1385-90. doi: 10.1016/s0140-6736(00)04560-8.

  PMID: 11356434 BACKGROUND

• Doughty RN, Whalley GA, Walsh HA, Gamble GD, Lopez-Sendon J, Sharpe N; CAPRICORN Echo Substudy Investigators. Effects of carvedilol on left ventricular remodeling after acute myocardial infarction: the CAPRICORN Echo Substudy. Circulation. 2004 Jan 20;109(2):201-6. doi: 10.1161/01.CIR.0000108928.25690.94. Epub 2004 Jan 5.

  PMID: 14707020 BACKGROUND

• Doughty RN, Whalley GA, Gamble G, MacMahon S, Sharpe N. Left ventricular remodeling with carvedilol in patients with congestive heart failure due to ischemic heart disease. Australia-New Zealand Heart Failure Research Collaborative Group. J Am Coll Cardiol. 1997 Apr;29(5):1060-6. doi: 10.1016/s0735-1097(97)00012-0.

  PMID: 9120160 BACKGROUND

• Greenberg BH, Mehra M, Teerlink JR, Ordronneau P, McCollum D, Gilbert EM. COMPARE: comparison of the effects of carvedilol CR and carvedilol IR on left ventricular ejection fraction in patients with heart failure. Am J Cardiol. 2006 Oct 2;98(7A):53L-59L. doi: 10.1016/j.amjcard.2006.08.003. Epub 2006 Aug 28.

  PMID: 17023233 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Interventions

Carvedilol

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring

Results Point of Contact

• Title: Sandy Stagge, RN, BSN
• Organization: CTI Clinical Trial and Consulting Services

sstagge@ctifacts.com

513-619-1837

Study Officials

• Barry Greenberg, MD

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2006
• First Posted: May 9, 2006
• Study Start: March 1, 2006
• Primary Completion: April 1, 2008
• Study Completion: June 1, 2008
• Last Updated: March 28, 2023
• Results First Posted: March 13, 2009

Record last verified: 2023-03

Locations

US (75)