Status:
UNKNOWN
Impact of Body Composition on Bisoprolol and Ramipril Pharmacokinetics in Patients With Chronic Heart Failure
Lead Sponsor:
The University Clinic of Pulmonary and Allergic Diseases Golnik
Conditions:
Chronic Heart Failure
Cachexia
Eligibility:
All Genders
18+ years
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 leas...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2013
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01829880
Start Date
October 1 2011
End Date
August 1 2013
Last Update
April 11 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Clinic of Respiratory and Allergic Diseases Golnik
Golnik, Slovenia, 4204