Response to Medication Registry

Adverse Drug Events Clinical Trial

Official title:

Response to Medication Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02593916
• Other study ID #: 128024
• Status: Completed
• Start date: March 2007
• Est. completion date: December 2018

Study information

• Verified date: March 2019
• Source: Intermountain Health Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

To create a registry/database of patients who either have taken drugs that treat cardiovascular conditions or that have presented with cardiovascular symptoms that may be related to medication.

Description:

To create a registry/database of patients who either have taken drugs that treat cardiovascular conditions or that have presented with cardiovascular symptoms that may be related to medication. Potential enrollees are those receiving (presently or in the past) the medicine(s) of interest. Subjects will be identified from computerized Intermountain Healthcare records. Patients receiving a drug of interest, both with and without an ADE will be enrolled in approximately equal numbers. Outpatients will be contacted by mail and invited to participate. Interested subjects will be instructed to return the enclosed response card with their intent indicated. The registry coordinator will contact interested subjects and the project will be explained. Willing participants will be enrolled either in person or via mail with the assistance of the project coordinator. Persons presenting in person for enrollment will be given the choice of venipuncture or buccal swab for sample collection for DNA extraction. In all cases informed consent will be obtained before collecting samples.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 196
• Est. completion date: December 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• The patient must be > 18 years of age.

• The patient or legally authorized representative must sign a written informed consent, prior to sample collection, using a form that is approved by the local Institutional Review Board.

• The patient must have taken a medication of interest or have presented with a cardiovascular symptom possibly related to medication. The current medications of interest are as follows:

• ACE inhibitors

• ARBs

• Aldosterone Antagonists

• Alpha-Andrenergic Agonists

• Anticoagulants

• B-Type Natriuretic Peptides

• Beta-blockers

• Calcium Channel Blockers

• Cardiac Glycosides

• Antiarrhythmics

• Combination Drugs

• Diuretics

• Electrolyte/Mineral Replacements

• Lipid-lowering Medications

• Positive Inotropes

• Vasodilators/Nitrates

• Statins

• Antibiotics

• Anthrocyclines

Exclusion Criteria:

• There are no exclusion criteria for this registry.

Related Conditions & MeSH terms

• Adverse Drug Events
• Drug-Related Side Effects and Adverse Reactions

Locations

Country	Name	City	State
United States	LDS Hospital	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Intermountain Health Care, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Genetic and biomarker correlates with clinical response(s) to medication	We will monitor clinical responses to medications for 5 years and look for genetic markers and biomarkers that correlate with these responses.	5 years
Secondary	Dosage adjustments	We will monitor medication dosage adjustments for 5 years and look for genetic markers and biomarkers that correlate with these adjustments.	5 years
Secondary	Beneficial responses	We will monitor beneficial responses to medications for 5 years and look for genetic markers and biomarkers that correlate with these responses.	5 years
Secondary	Adverse drug events	We will monitor adverse drug events for 5 years and look for genetic markers and biomarkers that correlate with these events.	5 years
Secondary	Drug interactions	We will monitor drug interactions for 5 years and look for genetic markers and biomarkers that correlate with these interactions.	5 years