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OpenTrials
Completed

NCT Number: NCT02593916

Response to Medication 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

LDS Hospital

Salt Lake City, Utah, 84143, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Genetic and biomarker correlates with clinical response(s) to medication

    Time frame: 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 outcomes

  1. Dosage adjustments

    Time frame: 5 years

    We will monitor medication dosage adjustments for 5 years and look for genetic markers and biomarkers that correlate with these adjustments.

  2. Beneficial responses

    Time frame: 5 years

    We will monitor beneficial responses to medications for 5 years and look for genetic markers and biomarkers that correlate with these responses.

  3. Adverse drug events

    Time frame: 5 years

    We will monitor adverse drug events for 5 years and look for genetic markers and biomarkers that correlate with these events.

  4. Drug interactions

    Time frame: 5 years

    We will monitor drug interactions for 5 years and look for genetic markers and biomarkers that correlate with these interactions.

Sponsors and collaborators

Lead sponsor

Intermountain Health Care, Inc.

Other

Registry information

Important dates

Study start
2007
Primary completion
2018
Study completion
2018
First posted
Nov 2, 2015
Registry last updated
Mar 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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