The Role of Clinical Pharmacist in Management of DDIs in CHF Patients

Chronic Heart Failure Clinical Trial

Official title:

The Role of Clinical Pharmacist's Intervention in Management of Clinically Relevant Drug-drug Interactions in Patients With Chronic Heart Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01855165
• Other study ID #: CHF42013
• Secondary ID: 109/01/13
• Status: Recruiting
• Phase: N/A
• First received: May 6, 2013
• Last updated: May 15, 2013
• Start date: April 2013
• Est. completion date: December 2013

Study information

• Verified date: May 2013
• Source: The University Clinic of Pulmonary and Allergic Diseases Golnik
• Contact: Mitja Lainscak, PhD
• Phone: +38642569141
• Email: mitja.lainscak[@]guest.arnes.si
• Is FDA regulated: No
• Health authority: Slovenia: National Medical Ethics Commutee of Republic of Slovenia
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Intervention

Behavioral:
• Advice on DDIs

Locations

Country	Name	City	State
Slovenia	University Clinic Golnik	Golnik

Sponsors (1)

Lead Sponsor	Collaborator
The University Clinic of Pulmonary and Allergic Diseases Golnik

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the difference in frequency and severity of clinically significant DDIs in control arm and interventional arm between admission and discharge	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	Yes