Impact of Body Composition Changes and Cachexia on Bisoprolol and Ramipril Pharmacokinetics and Renal Function Estimation in Patients With Chronic Heart Failure
Sponsor study identifier
observational
60
1 country
1
Study Start
October 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2011
Date type not reportedThis date has not been verified as actual or estimated.
April 8, 2013
Actual (reported)April 11, 2013
Actual (reported)July 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
August 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Body composition
Baseline and 6 months
Cachexia diagnosis
Baseline and 6 months
Patients with chronic heart failure who attend to internal medicine outpatient clinic.
Patients with chronic heart failure who attend internal medicine outpatient clinic
University Clinic of Respiratory and Allergic Diseases Golnik
Golnik, 4204, Slovenia
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.
Plasma, serum
Mitja Lainscak, MD, PhD
University Clinic Golnik
First Submitted
April 8, 2013
First Posted
April 11, 2013
Study Start
October 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2013
Estimated (date passed)Renal function
Baseline and 6 months
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 11, 2013
Record last verified: 2013-04
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