NCT03644446

Bisoprolol Plasma Residual Concentrations in Chronic Heart Failure

Bisoprolol Plasma Residual Concentrations for the Optimization of Drug Management in Heart Failure With Mild to Reduced Ejection Fraction

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 81 (estimated)
• Sponsor: University Hospital, Caen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study evaluate the dosage of bisoprolol plasma residual concentrations in chronic heart failure with mild to reduced ejection fraction adult patients by dose and renal function.

Detailed description

The clinical relevance of bisoprolol plasma residual concentration in the management of HF medical therapy and the impact of renal function on reaching the maximum tolerated dose has never been studied. The investigators will perform an observational study to answer this issue. In this study, there will be no changes of the doses of bisoprolol, whatever the bisoprolol plasma concentration, with the exception of vital threatening concentrations. This study is a pilot study. Participants will be consecutive ambulatory chronic heart failure patients followed at the CHU de Caen, treated with maximum tolerated dose of bisoprolol with mild to reduced ejection fraction. Participants can benefit of the other heart failure recommended treatment at the exception of ivabradine that would confound the bisoprolol effect on heart rate. Participants will be subsequently studied by renal function. Patients will be followed at one year with the electronic health record of the CHU de Caen for clinical events.

Conditions

• Heart Failure With Reduced Ejection Fraction

Interventions

Type	Name	Description
BIOLOGICAL	Bisoprolol plasma residual concentration dosage	Bisoprolol plasma residual concentration dosage will be subsequently studied by renal function (altered if creatinine clearance \< 30mL/min, mild altered between 30-60mL/min, normal \> 60mL/min as estimated by the CKD-EPI formula)

Timeline

• Start date: 2017-11-02
• Primary completion: 2019-11-02
• Completion: 2020-11-02
• First posted: 2018-08-23
• Last updated: 2018-08-23

Locations

1 site across 1 country: France