Clinical trial NCT03644446: Bisoprolol Plasma Residual Concentrations in Chronic Heart Failure
Official title: Bisoprolol Plasma Residual Concentrations for the Optimization of Drug Management in Heart Failure With Mild to Reduced Ejection Fraction
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure With Reduced Ejection Fraction
Keywords: Bisoprolol
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2018-08-23
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive ambulatory chronic HFrEF patients followed at the CHU de Caen, treated with maximum tolerated dose of bisoprolol. Patients can benefit of other HFrEF recommended treatment at the exception of ivabradine that would confound the bisoprolol effect on heart rate. Patients 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) and bisoprolol dose (5, 7.5 or 10mg).

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.

Eligibility criteria: 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)

Exclusion Criteria:

* Unstable HF, that are patients who presented in the last 3 months before inclusion an hospitalization for any cardiovascular event including HF, new onset or worsening of HF or coronary artery disease symptoms
* Patient refusing to participate
* Patients with a non maximum tolerated dose of bisoprolol
* Patients with ivabradine intakes
* Body weight \< 60kg or \> 100kg
* Severe liver insufficiency
* Pregnancy
* Liberty deprived patients

Primary outcomes:
measure: Bisoprolol residual plasma concentration by dose and renal function
timeFrame: At the time of inclusion
Secondary outcomes:
measure: Clinical parameters at the time of inclusion
timeFrame: At the time of inclusion
measure: Clinical parameters at the time of inclusion
timeFrame: At the time of inclusion
measure: Clinical parameters at the time of inclusion
timeFrame: At the time of inclusion
measure: Clinical parameters at the time of inclusion
timeFrame: At the time of inclusion
measure: Biological assessment
timeFrame: At the time of inclusion
measure: Biological assessment
timeFrame: At the time of inclusion
measure: Biological assessment
timeFrame: At the time of inclusion
measure: Clinical outcomes at one year
timeFrame: At one year follow-up
measure: Clinical outcomes at one year
timeFrame: At one year follow-up
measure: Clinical outcomes at one year
timeFrame: At one year follow-up
measure: Clinical outcomes at one year
timeFrame: At one year follow-up
Other outcomes:
Locations:
city: Caen
country: France
facility: Alexandre Joachim
state: Basse Normandie
Study officials:
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