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SELECT: Pharmacodynamic Study of Carvedilol Versus Metoprolol in Heart Failure

Sponsor
University of Utah (Other)
Overall Status
Completed
CT.gov ID
NCT00802230
Collaborator
GlaxoSmithKline (Industry)
25
Enrollment
1
Location
2
Arms
27
Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief 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 naïve 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Terbutaline Infusion
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
25 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Beta-Receptor SELECTivity of Carvedilol and Metoprolol Succinnate in Patients With Heart Failure: A Randomized Dose Ranging Trial (SELECT Trial)
Study Start Date :
Sep 1, 2002
Actual Primary Completion Date :
Dec 1, 2004
Actual Study Completion Date :
Dec 1, 2004

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 1

Carvedilol IR

Drug: Terbutaline Infusion
Active Comparator: 2

Metoprolol Succinate

Drug: Terbutaline Infusion

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Utah Salt Lake City Utah United States 84104

    Sponsors and Collaborators

    • University of Utah
    • GlaxoSmithKline

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00802230
    Other Study ID Numbers:
    • Select-B1B2
    First Posted:
    Dec 4, 2008
    Last Update Posted:
    Dec 4, 2008
    Last Verified:
    Dec 1, 2008
    Additional relevant MeSH terms:
    Heart Failure
    Terbutaline

    Study Results

    No Results Posted as of Dec 4, 2008