An analysis on distribution of serum concentration of bisoprolol and its effect on prognosis in patients with heart failure

Not Applicable

• Conditions: Patients with heart failure who are taking bisoprolol

• Registration Number: JPRN-UMIN000023353
• Lead Sponsor: The Cardiovascular Institute

Brief Summary

The data of 114 HF patients under once-daily bisoprolol was analyzed. In multivariate logistic regression analysis, independent predictors of high Bis-PC (1st tertile: >= 5.38 ng/mL) were age, eGFR, and bisoprolol dose. The cumulative incidence rates of the primary endpoint were 10.5%/13.2%/26.3% in low/middle/high Bis-PC categories, respectively (log rank test, p = 0.087). Bis-PC was independently associated with the primary endpoint (hazard ratio [HR], 1.19 [per ng/mL], 95% CI 1.03-1.36).

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07-27
• Study Completion: 2017-06-30
• Results First Posted: 2020-01-13
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

Not provided

Exclusion Criteria

(1) Inpatients at blood sampling of serum concentration (2) Dose of bisoprolol was changed within 1 month before blood sampling of serum concentration. (3) Bisoprolol was administered twice a day within 1 week before blood sampling of serum concentration. (4) Hyperthyroidism is diagnosed or suspected. (5) Patients who meet contraindications below: 1) Patients with advanced bradycardia (significant sinus bradycardia), atrioventricular block (II or III degree) , atrioventricular block, and/or sick sinus syndrome 2) Patients with diabetic ketoacidosis, and/or metabolic acidosis 3) Patients with cardiogenic shock 4) Patients with right-sided heart failure by pulmonary hypertension 5) Patients with heart failure requiring intravenous administration of inotropic agents and/or vasodilatory agents 6) Patients with decompensated heart failure 7) Patients with severe peripheral circulatory disturbance 8) Patients with untreated pheochromocytoma 9) Women who are pregnant or may be pregnant 10) Patients who have a history of hypersensitivity for bisoprolol (6) Patients who are judged by the researchers as inadequate for this study

Study & Design

• Study Type: Observational
• Study Design: Not specified