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Pharmacodynamic Study of Carvedilol Versus Metoprolol in Heart Failure

Information source: University of Utah
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Heart Failure

Intervention: Terbutaline Infusion (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: University of Utah

Summary

Metoprolol succinate is a beta1-selective beta-blocker, becoming non-selective at higher doses, while carvedilol is non-selective. We examined whether metoprolol remained beta1-selective compared to carvedilol during dose up-titration in Class C heart failure (HF) Beta-blocker nave patients. METHODS: Twenty-five NYHA FC II-III HF patients were randomized to carvedilol or metoprolol. Patients were studied at baseline and after 2 weeks of up-titration (metoprolol at 25, 50, 100, and 200 mg daily; carvedilol IR at 3. 125, 6. 25, 12. 5, 25 mg and 50mg twice daily). Beta2- blockade was determined by an infusion of terbutaline at 6 mg/kg over 1 hour. Glucose and potassium levels were serially measured at baseline, every 15 minutes for the 1st hour and 30 minutes for 2nd hour post-infusion. The median area under the curve (AUC) for glucose and potassium changes were calculated.

Clinical Details

Official title: Beta-Receptor SELECTivity of Carvedilol and Metoprolol Succinnate in Patients With Heart Failure: A Randomized Dose Ranging Trial (SELECT Trial)

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients eligible for the study had objective evidence of systolic dysfunction

(ejection fraction ≤40%), were >18 years of age, and were on stable optimal medical heart failure therapy excluding the use of beta-blockers within the previous 30 days. Exclusion Criteria:

- . Patients were excluded for active viral myocarditis; hemodynamically significant

valvular heart disease; hypertrophic cardiomyopathy, peripartum cardiomyopathy; contra-indications to beta-blockers (asthma or obstructive airway disease requiring scheduled bronchodilators or inhaled steroids), resting heart rate <55; supine blood pressure <85/50; second or third degree heart block); concomitant use of beta-agonists, beta-antagonists, or anti-arrhythmics; unstable angina; myocardial infarction or bypass surgery within 3 months; or significant renal insufficiency (creatinine >2. 5 mg/dL), liver disease (transaminase levels > 3 fold above laboratory normal), or anemia.

Locations and Contacts

University of Utah, Salt Lake City, Utah 84104, United States
Additional Information

Starting date: September 2002
Last updated: December 3, 2008

Page last updated: August 23, 2015

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