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SELECT Trial: Beta-Receptor Selectivity of Carvedilol and Metoprolol Succinate in Heart Failure
NCT00802230Phase 4
Key facts
- Status
- Completed
- Start
- Sep 2002
- Primary completion
- Dec 2004
- Countries
- 1
- Sponsor
- University of Utah
- Modality
- Small Molecules
- Drugs
- metoprololcarvedilol
- Conditions
- heart failure (HF)
01
Overview
Phase 4, randomised trial in heart failure (HF) comparing Carvedilol IR with Metoprolol Succinate (2 arms). Primary endpoints: Area Under the Curve for Glucose Changes at 2 weeks and Area Under the Curve for Potassium Changes at 2 weeks. Started Sep 2002; status: completed.
02
Design
2 arms- Study design
- Randomized
Carvedilol IR
Patients receive Carvedilol IR up-titrated over 2 weeks followed by a terbutaline infusion challenge.
Metoprolol Succinate
Patients receive Metoprolol Succinate up-titrated over 2 weeks followed by a terbutaline infusion challenge.
03
Who it enrols
Adult patients with NYHA Class II-III heart failure and LVEF <=40%, on stable optimal medical therapy but beta-blocker naïve for at least 30 days. Excludes patients with active viral myocarditis, significant valvular disease, hypertrophic/peripartum cardiomyopathy, contraindications to beta-blockers, resting HR <55, supine BP <85/50, heart block, recent MI/bypass, significant renal/liver insufficiency, or anemia.
04
Endpoints
Primary
Area Under the Curve for Glucose Changes
Area Under the Curve for Potassium Changes
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