Impact of Body Composition on Bisoprolol and Ramipril Pharmacokinetics in Patients With Chronic Heart Failure

NCT ID: NCT01829880

Last Updated: 2013-04-11

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2013-08-31

Brief Summary

The purpose of this study is to determine if cachexia and changes in body composition influence pharmacokinetics of bisoprolol and ramipril and the accuracy of equations for renal function estimation.

Detailed Description

Patients with chronic heart failure on treatment with bisoprolol and/or ramipril will be included. Study will consist of two study visits: baseline visit (V1) and visit which will be performed at least 6 months after baseline (V2). At both visits same procedures will be performed. On the day of the visit, patients will be asked to take their morning dose of bisoprolol and/or ramipril after the withdrawal of the first morning plasma sample. Additional 3 to 5 plasma samples will be taken within 5 hours post bisoprolol and/or ramipril dose in order to determine pharmacokinetic profile of both drugs. Body composition will be measured by bioimpedance and dual-energy X-ray absorptiometry. Renal function will be measured by clearance of intravenously administered iohexol. Biochemical parameters, muscle strength, fatigue and anorexia will be assessed in order to determine presence of cachexia.

Changes in body composition will be correlated with changes in pharmacokinetic parameters of bisoprolol and ramipril. Pharmacokinetic parameters in cachectic patients will be compared to pharmacokinetic parameters in non-cachectic patients. Parameters of body composition will be correlated with the difference between measured and estimated renal function.

Conditions

Chronic Heart Failure; Cachexia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Chronic heart failure patients

Patients with chronic heart failure who attend to internal medicine outpatient clinic.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Diagnosis of chronic heart failure of New York Heart Association Functional Classification (NYHA) class II and III
• On treatment with bisoprolol for at least 3 days and/or ramipril for at least 4 days before V1
• Able and willing to provide freely given written informed consent

Exclusion Criteria

• Chronic renal disease with estimated glomerular filtration rate calculated by Modification of Diet in Renal Disease (MDRD) equation < 40 mL/(min x 1,73 m2) at V1 or V2
• Liver disease or increased serum liver enzymes (bilirubin > 1.5 x normal, gamma-glutamyl transpeptidase (GGT) > 2.5 x normal, aspartate transaminase (AST) > 2.5 x normal, alanine transaminase (ALT) > 2.5 x normal) at V1 or V2
• Absence of bisoprolol or ramipril steady state concentrations at V1 or V2 or withdrawal of bisoprolol and/or ramipril in-between both visits
• Acute decompensation of heart failure in less than 4 weeks before V1 or V2
• Addition, withdrawal or change in dose of drugs that importantly influence bisoprolol or ramipril pharmacokinetics in-between V1 and V2
• Unable to understand and comply with protocol or to give informed consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University Clinic of Pulmonary and Allergic Diseases Golnik

OTHER

Sponsor Role: lead

Responsible Party

Mitja Lainščak

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mitja Lainscak, MD, PhD

Role: STUDY_CHAIR

University Clinic Golnik

Locations

University Clinic of Respiratory and Allergic Diseases Golnik

Golnik, , Slovenia

Site Status: RECRUITING

Countries

Slovenia

Central Contacts

Mitja Lainscak, MD, PhD

Role: CONTACT

mitja.lainscak@guest.arnes.si

(0) 4 256 9483 ext. +386

Katja Trobec, MPharm

Role: CONTACT

katja.trobec@klinika-golnik.si

(0) 4 256 9360 ext. +386

Facility Contacts

Mitja Lainscak, MD, PhD

Role: primary

mitja.lainscak@guest.arnes.si

(0) 4 256 9483 ext. +386

Katja Trobec, MPharm

Role: backup

katja.trobec@klinika-golnik.si

(0) 4 256 9360 ext. +386

References

Cvan Trobec K, Kerec Kos M, von Haehling S, Anker SD, Macdougall IC, Ponikowski P, Lainscak M. Iohexol clearance is superior to creatinine-based renal function estimating equations in detecting short-term renal function decline in chronic heart failure. Croat Med J. 2015 Dec;56(6):531-41. doi: 10.3325/cmj.2015.56.531.

Reference Type: DERIVED

PMID: 26718759 (View on PubMed)

Other Identifiers

GOLNIK_PKT1

Identifier Type: -

Identifier Source: org_study_id