Chronic Heart Failure Clinical Trial
Official title:
Impact of Body Composition Changes and Cachexia on Bisoprolol and Ramipril Pharmacokinetics and Renal Function Estimation in Patients With Chronic Heart Failure
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.
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.
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Observational Model: Cohort, Time Perspective: Prospective
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