Pharmacodynamic Study of Carvedilol Versus Metoprolol in Heart Failure
SELECT
Beta-Receptor SELECTivity of Carvedilol and Metoprolol Succinnate in Patients With Heart Failure: A Randomized Dose Ranging Trial (SELECT Trial)
1 other identifier
interventional
25
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 heart-failure
Started Sep 2002
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2004
CompletedFirst Submitted
Initial submission to the registry
December 2, 2008
CompletedFirst Posted
Study publicly available on registry
December 4, 2008
CompletedNovember 8, 2023
December 1, 2008
2.3 years
December 2, 2008
November 6, 2023
Conditions
Study Arms (2)
1
ACTIVE COMPARATORCarvedilol IR
2
ACTIVE COMPARATORMetoprolol Succinate
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Utahlead
- GlaxoSmithKlinecollaborator
Study Sites (1)
University of Utah
Salt Lake City, Utah, 84104, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 2, 2008
First Posted
December 4, 2008
Study Start
September 1, 2002
Primary Completion
December 1, 2004
Study Completion
December 1, 2004
Last Updated
November 8, 2023
Record last verified: 2008-12