Overview

This trial is active, not recruiting.

Condition adverse drug events
Sponsor Intermountain Health Care, Inc.
Start date March 2007
End date September 2018
Trial size 196 participants
Trial identifier NCT02593916, 128024

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
Genetic and biomarker correlates with clinical response(s) to medication
time frame: 5 years

Secondary Outcomes

Measure
Dosage adjustments
time frame: 5 years
Beneficial responses
time frame: 5 years
Adverse drug events
time frame: 5 years
Drug interactions
time frame: 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Response to Medication Registry
Principal investigator John F Carlquist, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Intermountain Health Care, Inc..