Heart Failure With Reduced Ejection Fraction
Conditions
Keywords
Bisoprolol
Brief 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.
Interventions
BIOLOGICALBisoprolol 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)
Sponsors
University Hospital, Caen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Consecutive ambulatory patients with chronic heart failure with mild to reduced ejection fraction (LVEF \< 50%) at the CHU de Caen * Aged 18 y.o. or older * With a stable heart failure (see
Exclusion criteria
) * At the maximum tolerated dose of bisoprolol for at least one week (maximum dose reached without adverse tolerance event: orthostatic hypotension, symptomatic bradycardia, fatigue related to the treatment)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bisoprolol residual plasma concentration by dose and renal function | At the time of inclusion | Bisoprolol plasma residual concentrations will be performed by liquid chromatography with tandem mass spectrometry (LC-MS/MS) with simple precipitation of proteins with acetonitrile, as described by Liu et al. The quantification will be in positive mode by multiple reaction monitoring with the following transitions: 326 to 116 for bisoprolol and 256 to 167 for diphenhydramine (control). Bisoprolol concentrations will be expressed in µg/L. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical parameters at the time of inclusion | At the time of inclusion | Heart rate in beats per minute (bpm). Heart rate will be studied as a continous outcome and as a dichotomous outcome for efficacy. The efficacy parameter cutoff is a heart rate \< 70bpm. |
| Biological assessment | At the time of inclusion | Routine biological evaluation : creatinine (in µmol/L) |
| Clinical outcomes at one year | At one year follow-up | Heart failure symptoms worsening (dichotomous variable) |
Countries
France
Outcome results
None listed