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Pharmacodynamic Study of Carvedilol Versus Metoprolol in Heart Failure (SELECT)

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ClinicalTrials.gov Identifier: NCT00802230
Recruitment Status : Completed
First Posted : December 4, 2008
Last Update Posted : December 4, 2008
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
University of Utah

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
Heart Failure Drug: Terbutaline Infusion Phase 4

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Study Type : Interventional  (Clinical Trial)
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 : September 2002
Actual Primary Completion Date : December 2004
Actual Study Completion Date : December 2004


Arm Intervention/treatment
Active Comparator: 1
Carvedilol IR
Drug: Terbutaline Infusion
Active Comparator: 2
Metoprolol Succinate
Drug: Terbutaline Infusion




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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00802230


Locations
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United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84104
Sponsors and Collaborators
University of Utah
GlaxoSmithKline

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Responsible Party: Edward M. Gilbert, M.D.
ClinicalTrials.gov Identifier: NCT00802230     History of Changes
Other Study ID Numbers: Select-B1B2
First Posted: December 4, 2008    Key Record Dates
Last Update Posted: December 4, 2008
Last Verified: December 2008

Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Metoprolol
Carvedilol
Terbutaline
Anti-Arrhythmia Agents
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antioxidants
Protective Agents
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Bronchodilator Agents
Anti-Asthmatic Agents
Respiratory System Agents
Sympathomimetics