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

NCT01829880 | Unknown

• 1 other identifier: GOLNIK_PKT1
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Heart Failure; Cachexia

Keywords

Chronic heart failure; Bisoprolol; Ramipril; Pharmacokinetic; Cachexia; Body composition; Renal function; Iohexol

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetic parameters of bisoprolol and ramipril

  Pharmacokinetic parameters of bisoprolol and ramipril(clearance, volume of distribution, area under concentration-time curve, maximal concentration, time to maximal concentration) will be determined. The relation between pharmacokinetic parameters and body composition/cachexia will be assessed.

  Baseline and 6 months

Secondary Outcomes (3)

• Body composition

  Baseline and 6 months

• Cachexia diagnosis

  Baseline and 6 months

• Renal function

  Baseline and 6 months

Study Arms (1)

Chronic heart failure patients

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic heart failure who attend internal medicine outpatient clinic

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University Clinic of Pulmonary and Allergic Diseases Golnik: lead

Study Sites (1)

University Clinic of Respiratory and Allergic Diseases Golnik

Golnik, 4204, Slovenia

RECRUITING

Related Publications (1)

• 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.

  PMID: 26718759 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma, serum

MeSH Terms

Conditions

Cachexia

Condition Hierarchy (Ancestors)

Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness

Study Officials

• Mitja Lainscak, MD, PhD

  University Clinic Golnik

  STUDY CHAIR

Central Study Contacts

Mitja Lainscak, MD, PhD

CONTACT

(0) 4 256 9483; mitja.lainscak@guest.arnes.si

Katja Trobec, MPharm

CONTACT

(0) 4 256 9360; katja.trobec@klinika-golnik.si

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 8, 2013
• First Posted: April 11, 2013
• Study Start: October 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: August 1, 2013
• Last Updated: April 11, 2013

Record last verified: 2013-04

Locations

SL (1)