Clinical trial NCT00272805: Drug Compliance and Quality of Life in Patients With Heart Failure Dosed With Either Once-daily or Twice-daily Coreg
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Heart Failure
Keywords: chronic heart failure
left ventricular systolic dysfunction
Lead sponsor: Cardiovascular Clinical Sciences Inc
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2006-01-09
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility 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.

Primary outcomes:
measure: Dosing compliance: pill taking total taken vs number prescribed
Secondary outcomes:
measure: quality of life
Other outcomes:
Locations:
city: Mobile
country: United States
facility: The Heart Group
state: Alabama
city: Sierra Vista
country: United States
facility: Radiant Research
state: Arizona
city: Anaheim
country: United States
facility: Cardiology Consultants of Orange County
state: California
city: Beverly Hills
country: United States
facility: Access Clinical Trials
state: California
city: Oakland
country: United States
facility: Cardiovascular Consultants Medical Group
state: California
city: San Diego
country: United States
facility: San Diego Cardiac Center
state: California
city: Santa Rosa
country: United States
facility: Northern California Medical Associates
state: California
city: Santa Rosa
country: United States
facility: Radiant Research
state: California
city: Walnut Creek
country: United States
facility: Cardiovascular Consultants Medical Group
state: California
city: Fort Collins
country: United States
facility: Heart Center of the Rockies
state: Colorado
city: Hartford
country: United States
facility: St. Francis Hospital and Medical Center
state: Connecticut
city: Miami
country: United States
facility: NextPhase Clinical Trials
state: Florida
city: Port Charlotte
country: United States
facility: Charlotte Heart Group Research Center
state: Florida
city: St. Petersburg
country: United States
facility: The Heart and Vascular Institute of Florida
state: Florida
city: Atlanta
country: United States
facility: Cardiac Disease Specialists
state: Georgia
city: Augusta
country: United States
facility: CVMS Research Institute of Augusta
state: Georgia
city: Covington
country: United States
facility: Georgia Heart Specialists
state: Georgia
city: Boise
country: United States
facility: Idaho Cardiology Associates
state: Idaho
city: Bannockburn
country: United States
facility: North Shore Cardiologists
state: Illinois
city: Lombard
country: United States
facility: Midwest Heart Foundation
state: Illinois
city: Normal
country: United States
facility: Illinois Heart and Lung Research Center
state: Illinois
city: Indianapolis
country: United States
facility: The Care Group
state: Indiana
city: Metairie
country: United States
facility: Clinical Trials Management
state: Louisiana
city: Auburn
country: United States
facility: Androscoggin Cardiology Associates-Research
state: Maine
city: S.Portland
country: United States
facility: Maine Cardiology Associates
state: Maine
city: Scarborough
country: United States
facility: Cardiovascular Consultants of Maine
state: Maine
city: Ayer
country: United States
facility: Primary Care Cardiology Research
state: Massachusetts
city: Burlington
country: United States
facility: Lahey Clinic Cardiology
state: Massachusetts
city: Haverhill
country: United States
facility: Pentucket Medical Associates
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Lincoln
country: United States
facility: Bryan LGH Heart Institute
state: Nebraska
city: Las Vegas
country: United States
facility: Lovelace Scientific Resources
state: Nevada
city: Cherry Hill
country: United States
facility: Associated Cardiovascular Consultants
state: New Jersey
city: Albuquerque
country: United States
facility: University of New Mexico Health Science Center
state: New Mexico
city: Albany
country: United States
facility: Albany Associates in Cardiology
state: New York
city: Garden City
country: United States
facility: Cardiovascular Medical Associates
state: New York
city: Kingston
country: United States
facility: MidValley Cardiology
state: New York
city: New York
country: United States
facility: New York University Medical School
state: New York
city: West Islip
country: United States
facility: South Bay Cardiovascular Associates
state: New York
city: Burlington
country: United States
facility: Alamance Regional Medical Center
state: North Carolina
city: Akron
country: United States
facility: Akron General Medical Center
state: Ohio
city: Cincinnati
country: United States
facility: The Lindner Clinical Trial Center
state: Ohio
city: Cincinnati
country: United States
facility: New Horizons Clinical Research
state: Ohio
city: Dayton
country: United States
facility: The Dayton Heart Center
state: Ohio
city: Lorain
country: United States
facility: North Ohio Research Ltd.
state: Ohio
city: Sandusky
country: United States
facility: North Ohio Research Ltd.
state: Ohio
city: Bartlesville
country: United States
facility: Blue Stem Cardiology
state: Oklahoma
city: Corvallis
country: United States
facility: Cardiovascular Consultants of Oregon
state: Oregon
city: Eugene
country: United States
facility: Oregon Medical Group Clinical Research
state: Oregon
city: Sayre
country: United States
facility: Guthrie Clinic Ltd.
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Heart Failure Center
state: Rhode Island
city: Longview
country: United States
facility: DCOL Center for Clinical Research
state: Texas
city: Salt Lake City
country: United States
facility: LDS Hospital Cardiovascular Research
state: Utah
city: Elkhorn
country: United States
facility: Arrythmia Center for Southern Wisconsin
state: Wisconsin
Study officials:
affiliation: Cardiovascular Clinical Studies, Inc.
name: James E. Udelson, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Udelson JE, Pressler SJ, Sackner-Bernstein J, Massaro J, Ordronneau P, Lukas MA, Hauptman PJ. Adherence with once daily versus twice daily carvedilol in patients with heart failure: the Compliance And Quality of Life Study Comparing Once-Daily Controlled-Release Carvedilol CR and Twice-Daily Immediate-Release Carvedilol IR in Patients with Heart Failure (CASPER) Trial. J Card Fail. 2009 Jun;15(5):385-93. doi: 10.1016/j.cardfail.2008.12.010. Epub 2009 Feb 12.