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Impact of Body Composition on Bisoprolol and Ramipril Pharmacokinetics in Patients With Chronic Heart Failure

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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
Sponsor:
Information provided by (Responsible Party):
Mitja Lainščak, The University Clinic of Pulmonary and Allergic Diseases Golnik

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.

Condition or disease
Chronic Heart Failure Cachexia

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 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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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

Drug Information available for: Bisoprolol

Group/Cohort
Chronic heart failure patients
Patients with chronic heart failure who attend to internal medicine outpatient clinic.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. Cachexia diagnosis [ Time Frame: Baseline and 6 months ]
    Cachexia diagnosis (determination of low body mass index, wasting, biochemical parameters, muscle strength, fatigue and anorexia)

  3. 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
Plasma, serum


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with chronic heart failure who attend internal medicine outpatient clinic
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01829880


Contacts
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Contact: Mitja Lainscak, MD, PhD (0) 4 256 9483 ext +386 mitja.lainscak@guest.arnes.si
Contact: Katja Trobec, MPharm (0) 4 256 9360 ext +386 katja.trobec@klinika-golnik.si

Locations
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Slovenia
University Clinic of Respiratory and Allergic Diseases Golnik Recruiting
Golnik, Slovenia, 4204
Contact: Mitja Lainscak, MD, PhD    (0) 4 256 9483 ext +386    mitja.lainscak@guest.arnes.si   
Contact: Katja Trobec, MPharm    (0) 4 256 9360 ext +386    katja.trobec@klinika-golnik.si   
Principal Investigator: Mitja Lainscak, MD, PhD         
Sub-Investigator: Katja Trobec, MPharm         
Sponsors and Collaborators
The University Clinic of Pulmonary and Allergic Diseases Golnik
Investigators
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Study Chair: Mitja Lainscak, MD, PhD University Clinic Golnik
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mitja Lainščak, MD, PhD, The University Clinic of Pulmonary and Allergic Diseases Golnik
ClinicalTrials.gov Identifier: NCT01829880    
Other Study ID Numbers: GOLNIK_PKT1
First Posted: April 11, 2013    Key Record Dates
Last Update Posted: April 11, 2013
Last Verified: April 2013
Keywords provided by Mitja Lainščak, The University Clinic of Pulmonary and Allergic Diseases Golnik:
Chronic heart failure
Bisoprolol
Ramipril
Pharmacokinetic
Cachexia
Body composition
Renal function
Iohexol
Additional relevant MeSH terms:
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Heart Failure
Wasting Syndrome
Cachexia
Heart Diseases
Cardiovascular Diseases
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Metabolic Diseases
Nutrition Disorders