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

An analysis on distribution of serum concentration of bisoprolol and its effect on prognosis in patients with heart failure - CVI ARO 6 study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000023353

Enrollment

240

Registered

2016-07-27

Start date

2016-07-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with heart failure who are taking bisoprolol

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who are visiting to the Cardiovascular Institute and taking bisoprolol with diagnosis of heart failure. Patients who meets all of the criteria below. (1) Age: 20 years and older (2) In ultrasound cardiogram within 1 year before registration (if multiple data exists, the latest one), systolic dysfunction (left ventricular ejection fraction [LVEF] <50%), or diastolic dysfunction (LVEF >=50% and E/E' >=15) are observed. (3) Bisoprolol is constantly taken for more than 1 month at blood sampling of serum concentration. (4) Bisoprolol is administered once a day. (5) Outpatients

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Admission or death by heart failure within 1 year after registration	—

Secondary

Measure	Time frame
Primary outcomes and increase of diuretics due to exacerbation of heart failure (loop diuretics, potassium sparing diuretics, thiazide diuretics, selective vasopressin V2-receptor antagonists)	—

Countries

Japan

Contacts

Public ContactKazumi Matsuda

Cardiovascular Institute Academic Research Organization (CVI ARO) Head office

matsuda@cvi.or.jp+81-3-3408-2151

Outcome results