Clinical trial NCT02593916: Response to Medication Registry
Official title: Response to Medication Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adverse Drug Events
Lead sponsor: Intermountain Health Care, Inc.
Sponsor class: OTHER
First posted: 2015-11-01
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Genetic and biomarker correlates with clinical response(s) to medication
timeFrame: 5 years
Secondary outcomes:
measure: Dosage adjustments
timeFrame: 5 years
measure: Beneficial responses
timeFrame: 5 years
measure: Adverse drug events
timeFrame: 5 years
measure: Drug interactions
timeFrame: 5 years
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: LDS Hospital
state: Utah
Study officials:
affiliation: LDS Hospital
name: John F Carlquist, PhD
role: PRINCIPAL_INVESTIGATOR
References: