Clinical trial

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

Name
Select-B1B2
Description
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 arms
Trial start
2002-09-01
Estimated PCD
2004-12-01
Trial end
2004-12-01
Status
Completed
Phase
Early phase I
Treatment
Terbutaline Infusion
Arms:
1, 2
Size
25
Eligibility 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 25, 'type': 'ACTUAL'}}
Updated at
2023-11-08

1 organization

1 product

1 indication

Organization
University of Utah