Adverse Drug Events Clinical Trial
Official title:
Response to Medication Registry
NCT number | NCT02593916 |
Other study ID # | 128024 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 2007 |
Est. completion date | December 2018 |
Verified date | March 2019 |
Source | Intermountain Health Care, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient 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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | LDS Hospital | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
Intermountain Health Care, Inc. |
United States,
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 |
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