NCT02593916

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
196

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
8.7 years until next milestone

First Submitted

Initial submission to the registry

October 29, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 2, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

March 14, 2019

Status Verified

March 1, 2019

Enrollment Period

11.5 years

First QC Date

October 29, 2015

Last Update Submit

March 13, 2019

Conditions

Adverse Drug Events

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Dosage adjustments

    5 years

  • Beneficial responses

    5 years

  • Adverse drug events

    5 years

  • Drug interactions

    5 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LDS Hospital

Salt Lake City, Utah, 84143, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

* blood samples * buccal samples

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Officials

  • John F Carlquist, PhD

    LDS Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2015

First Posted

November 2, 2015

Study Start

March 1, 2007

Primary Completion

September 1, 2018

Study Completion

December 1, 2018

Last Updated

March 14, 2019

Record last verified: 2019-03

Locations

US(1)