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

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.

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.