- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01855165
The Role of Clinical Pharmacist in Management of DDIs in CHF Patients
May 15, 2013 updated by: The University Clinic of Pulmonary and Allergic Diseases Golnik
The Role of Clinical Pharmacist's Intervention in Management of Clinically Relevant Drug-drug Interactions in Patients With Chronic Heart Failure
Drug-drug interactions (DDIs) are common in patients with chronic heart failure (CHF) and their incidence increases with the number of drugs that the patients are prescribed for treatment of their condition.
Data bases often detect DDIs that are of high clinical relevance.
The investigators have performed this study in order to detect clinically significant DDIs and to diminish their occurrence by sending notification about DDIs to attending physician.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mitja Lainscak, PhD
- Phone Number: +38642569141
- Email: mitja.lainscak@guest.arnes.si
Study Locations
-
-
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Golnik, Slovenia, 4204
- Recruiting
- University Clinic Golnik
-
Contact:
- Mitja Lainscak, Md, PhD
- Phone Number: +38642569141
- Email: mitja.lainscak@guest.arnes.si
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients admitted with diagnosis of CHF I50.0 - I50.9 and I11.0 - I11.9 (ICD-10)
- patients treated with at least two drugs
Exclusion Criteria:
- Patients admitted to other conditions
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Advice on DDIs
Attending physician will be randomly assigned to intervention arm care as usual; in the intervention arm, he/she will receive advice about DDIs between medications prescribed to patients on top of general heart failure advice.
|
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No Intervention: General advice
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To assess the difference in frequency and severity of clinically significant DDIs in control arm and interventional arm between admission and discharge
Time Frame: 90 days
|
We will measure the difference in clinically significant DDIs between admission and discharge.
The doctors in control group will not receive the advice about DDIs between drugs prescribed to patient, while the doctors in interventional group will.
With this will will assess the impact of the advice in the occurence of DDIs between admission and discharge for both groups.
|
90 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Mitja Lainscak, PhD, University Clinic Golnik
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2013
Primary Completion (Anticipated)
December 1, 2013
Study Completion (Anticipated)
December 1, 2013
Study Registration Dates
First Submitted
May 6, 2013
First Submitted That Met QC Criteria
May 15, 2013
First Posted (Estimate)
May 16, 2013
Study Record Updates
Last Update Posted (Estimate)
May 16, 2013
Last Update Submitted That Met QC Criteria
May 15, 2013
Last Verified
May 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHF42013
- 109/01/13 (Other Identifier: National Medical Ethics Committee of the Republic of Slovenia (NMEC))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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