Response to Medication Registry

Completed

• Conditions: Adverse Drug Events

• Registration Number: NCT02593916
• Lead Sponsor: Intermountain Health Care, Inc.

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2015-10-29
• Study First Submitted QC: 2015-10-29
• Study First Posted: 2015-11-01
• Primary Completion: 2018-09
• Study Completion: 2018-12
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-13
• Last Update Posted: 2019-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 196

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Genetic and biomarker correlates with clinical response(s) to medication	5 years	We will monitor clinical responses to medications for 5 years and look for genetic markers and biomarkers that correlate with these responses.

Secondary Outcome Measures

Name	Time	Method
Adverse drug events	5 years	We will monitor adverse drug events for 5 years and look for genetic markers and biomarkers that correlate with these events.
Dosage adjustments	5 years	We will monitor medication dosage adjustments for 5 years and look for genetic markers and biomarkers that correlate with these adjustments.
Beneficial responses	5 years	We will monitor beneficial responses to medications for 5 years and look for genetic markers and biomarkers that correlate with these responses.
Drug interactions	5 years	We will monitor drug interactions for 5 years and look for genetic markers and biomarkers that correlate with these interactions.

Trial Locations

Locations (1)

LDS Hospital; 🇺🇸 Salt Lake City, Utah, United States