Response to Medication Registry

Study Overview
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Brief Summary
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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
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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.

Official Title
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Response to Medication Registry

Conditions
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Adverse Drug Events

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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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 |