Suspended

Body Composition Changes, Cachexia Impact on Bisoprolol and Ramipril Pharmacokinetics in Chronic Heart Failure Patients

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Study Aim

This observational study aims to determine how body composition changes and cachexia impact the pharmacokinetics of bisoprolol and ramipril in patients with chronic heart failure, by measuring clearance, volume of distribution, area under concentration-time curve, maximal concentration, and time to maximal concentration.

What is being collected

Data Collection

Collected from today forward - Prospective
No DNA Sample
Who is being recruted

Body Weight+4

+ Body Weight Changes

+ Signs and Symptoms

Over 18 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: October 2011
See protocol details

Summary

Principal SponsorThe University Clinic of Pulmonary and Allergic Diseases Golnik
Study ContactMitja Lainscak, MD, PhDMore contacts
Last updated: April 11, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2011

Actual date on which the first participant was enrolled.

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.

NCT01829880
Principal SponsorThe University Clinic of Pulmonary and Allergic Diseases Golnik
Study ContactMitja Lainscak, MD, PhDMore contacts
Last updated: April 11, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Body WeightBody Weight ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsThinnessWeight LossCachexia

Criteria

3 inclusion criteria required to participate
Able and willing to provide freely given written informed consent
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
6 exclusion criteria prevent from participating
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
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
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

University Clinic of Respiratory and Allergic Diseases Golnik

Golnik, SloveniaOpen University Clinic of Respiratory and Allergic Diseases Golnik in Google Maps
SuspendedOne Study Center