Response to Medication Registry

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.

Study Overview

• Status: Completed
• Conditions: Adverse Drug Events

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 Type: Observational
• Enrollment (Actual): 196

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84143
      • LDS Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients from existing Intermountain Healthcare databases and registries who either have taken drugs that treat cardiovascular conditions or that have presented with cardiovascular symptoms that may be related to medication.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Drug interactions	We will monitor drug interactions for 5 years and look for genetic markers and biomarkers that correlate with these interactions.	5 years

Collaborators and Investigators

• Sponsor: Intermountain Health Care, Inc.
• Investigators: Principal Investigator: John F Carlquist, PhD, LDS Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (Actual): September 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: October 29, 2015
• First Submitted That Met QC Criteria: October 29, 2015
• First Posted (Estimate): November 1, 2015

Study Record Updates

• Last Update Posted (Actual): March 14, 2019
• Last Update Submitted That Met QC Criteria: March 13, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Drug-Related Side Effects and Adverse Reactions
• Other Study ID Numbers: 128024