Adverse Drug Events
Conditions
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.
Interventions
None listed
Sponsors
Intermountain Health Care, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| Drug interactions | 5 years | We will monitor drug interactions for 5 years and look for genetic markers and biomarkers that correlate with these interactions. |
Countries
United States
Outcome results
None listed