Impact of Body Composition on Bisoprolol and Ramipril Pharmacokinetics in Patients With Chronic Heart Failure
|ClinicalTrials.gov Identifier: NCT01829880|
Recruitment Status : Unknown
Verified April 2013 by Mitja Lainščak, The University Clinic of Pulmonary and Allergic Diseases Golnik.
Recruitment status was: Recruiting
First Posted : April 11, 2013
Last Update Posted : April 11, 2013
|Condition or disease|
|Chronic Heart Failure Cachexia|
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.
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||Impact of Body Composition Changes and Cachexia on Bisoprolol and Ramipril Pharmacokinetics and Renal Function Estimation in Patients With Chronic Heart Failure|
|Study Start Date :||October 2011|
|Estimated Primary Completion Date :||July 2013|
|Estimated Study Completion Date :||August 2013|
Chronic heart failure patients
Patients with chronic heart failure who attend to internal medicine outpatient clinic.
- Pharmacokinetic parameters of bisoprolol and ramipril [ Time Frame: Baseline and 6 months ]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.
- Body composition [ Time Frame: Baseline and 6 months ]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
- Cachexia diagnosis [ Time Frame: Baseline and 6 months ]Cachexia diagnosis (determination of low body mass index, wasting, biochemical parameters, muscle strength, fatigue and anorexia)
- Renal function [ Time Frame: Baseline and 6 months ]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.
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01829880
|Contact: Mitja Lainscak, MD, PhD||(0) 4 256 9483 ext +email@example.com|
|Contact: Katja Trobec, MPharm||(0) 4 256 9360 ext +firstname.lastname@example.org|
|University Clinic of Respiratory and Allergic Diseases Golnik||Recruiting|
|Golnik, Slovenia, 4204|
|Contact: Mitja Lainscak, MD, PhD (0) 4 256 9483 ext +386 email@example.com|
|Contact: Katja Trobec, MPharm (0) 4 256 9360 ext +386 firstname.lastname@example.org|
|Principal Investigator: Mitja Lainscak, MD, PhD|
|Sub-Investigator: Katja Trobec, MPharm|
|Study Chair:||Mitja Lainscak, MD, PhD||University Clinic Golnik|