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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | August 2013 |
Est. primary completion date | July 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Slovenia | University Clinic of Respiratory and Allergic Diseases Golnik | Golnik |
Lead Sponsor | Collaborator |
---|---|
The University Clinic of Pulmonary and Allergic Diseases Golnik |
Slovenia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | Body composition | Body composition (percentage and amount of body fat, lean body mass, dry lean body mass and body water) will be measured by bioimpedance and dual energy X-ray absorptiometry | Baseline and 6 months | No |
Secondary | Cachexia diagnosis | Cachexia diagnosis (determination of low body mass index, wasting, biochemical parameters, muscle strength, fatigue and anorexia) | Baseline and 6 months | No |
Secondary | Renal function | Renal function will be measured by clearance of intravenously applied iohexol. Estimation of renal function will be calculated with different equations based on serum creatinine concentration. Measured and estimated renal function will be compared and the differences related to body composition parameters. | Baseline and 6 months | No |
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