Bisoprolol Plasma Residual Concentrations in Chronic Heart Failure

NCT03644446 | Unknown

• 1 other identifier: DC-2016-2725
• Study Type: observational
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure With Reduced Ejection Fraction

Keywords

Bisoprolol

Outcome Measures

Primary Outcomes (1)

• Bisoprolol residual plasma concentration by dose and renal function

  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.

  At the time of inclusion

Secondary Outcomes (11)

• Clinical parameters at the time of inclusion

  At the time of inclusion

• Clinical parameters at the time of inclusion

  At the time of inclusion

• Clinical parameters at the time of inclusion

  At the time of inclusion

• Clinical parameters at the time of inclusion

  At the time of inclusion

• Biological assessment

  At the time of inclusion

Study Arms (3)

Bisoprolol 5mg

Chronic heart failure with mild to reduced ejection fraction adult patients with bisoprolol intakes at 5mg (patient's maximum tolerated dose), stable, with a left ventricular ejection fraction \< 50%. Consecutive patients at the CHU de Caen.

Biological: Bisoprolol plasma residual concentration dosage

Bisoprolol 7.5mg

Chronic heart failure with mild to reduced ejection fraction adult patients with bisoprolol intakes at 7.5mg (patient's maximum tolerated dose), stable, with a left ventricular ejection fraction \< 50%. Consecutive patients at the CHU de Caen.

Biological: Bisoprolol plasma residual concentration dosage

Bisoprolol 10mg

Chronic heart failure with mild to reduced ejection fraction adult patients with bisoprolol intakes at 10mg (patient's maximum tolerated dose), stable, with a left ventricular ejection fraction \< 50%. Consecutive patients at the CHU de Caen.

Biological: Bisoprolol plasma residual concentration dosage

Interventions

Bisoprolol plasma residual concentration dosage BIOLOGICAL

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)

Bisoprolol 10mg; Bisoprolol 5mg; Bisoprolol 7.5mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

Alexandre Joachim

Caen, Basse Normandie, 14000, France

RECRUITING

Related Publications (28)

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Biospecimen

Retention: SAMPLES WITHOUT DNA

One blood sample for each patient at the time of inclusion.

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2018
• First Posted: August 23, 2018
• Study Start: November 2, 2017
• Primary Completion: November 2, 2019
• Study Completion: November 2, 2020
• Last Updated: August 23, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)