Medications and the Risk of Sudden Cardiac Death

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00241800
First received: October 17, 2005
Last updated: April 26, 2012
Last verified: April 2012
  Purpose

To investigate a potential relationship between four different classes of non-cardiovascular drugs and the risk of sudden cardiac death.


Condition
Cardiovascular Diseases
Heart Diseases
Death, Sudden, Cardiac
Ventricular Fibrillation

Study Type: Observational
Study Design: Time Perspective: Retrospective

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: September 2005
Study Completion Date: May 2010
Detailed Description:

BACKGROUND:

There are more than 400,000 sudden cardiac deaths annually in the U.S, of which 85% or more are caused by ventricular tachyarrhythmias. Medications are an important modifiable risk factor because many have effects that can provoke lethal arrhythmias. There is increasing suspicion that several drugs in four widely used classes of non-cardiovascular medications-fluoroquinolone and macrolide antibiotics, antipsychotics, and antidepressants- are pro-arrhythmic and thus increase the risk of sudden cardiac death. Published epidemiologic studies have quantified the risk conferred by older antipsychotics and antidepressants as well as oral erythromycin. The current project will extend these studies to newer medications that are used by an estimated 20% of adults in the U.S. Studies of surrogate markers suggest that the pro-arrhythmic effects of these drugs vary markedly.

DESIGN NARRATIVE:

This retrospective cohort study has three specific aims in testing the relationship between certain non-cardiovascular medications-fluoroquinolone and macrolide antibiotics, antipsychotics, and antidepressants- and sudden cardiac death.. Specific aim 1 tests the hypothesis that there is corresponding variation in risk of sudden cardiac death. In vivo data suggest that concurrent use of study drugs with other common medications that inhibit their metabolism could markedly increase drug concentrations, and thus risk of arrhythmias. Specific aim 2 tests the hypothesis that these pharmacokinetic interactions, defined a priori, increase risk of sudden cardiac death. The hypokalemia caused by the commonly used potassium-wasting diuretics may amplify the pro-arrhythmic effects of medications. Specific aim 3 tests the hypothesis that concurrent use of study drugs and these diuretics increases risk of sudden cardiac death. The investigators will conduct a retrospective cohort study in TennCare, Tennessee's expanded Medicaid program. Computerized TennCare files, linked with death certificates, provide the information necessary to define the cohort, classify followup according to medication exposure and potential confounders, and identify cases of sudden cardiac death using a validated computer case definition we have developed. The cohort will include an estimated 800,000 persons with 15,000 sudden cardiac deaths during 5,000,000 person years of followup and thus will have excellent power for risk estimates. The study will provide data that clinicians need to prescribe these widely used medications in a way that minimizes the risk of sudden cardiac death.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

No eligibility criteria

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00241800

Sponsors and Collaborators
Investigators
Investigator: Wayne Ray Vanderbilt University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00241800     History of Changes
Other Study ID Numbers: 1315
Study First Received: October 17, 2005
Last Updated: April 26, 2012
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Death
Ventricular Fibrillation
Death, Sudden, Cardiac
Death, Sudden
Pathologic Processes
Arrhythmias, Cardiac
Heart Arrest

ClinicalTrials.gov processed this record on October 01, 2014