Last reviewed · How we verify

NCT03549468: ELEVATE-ICM

The Effect of Low LEVel TrAgus STimulation on the Electrophysiological Substrate of Patients With Ischemic CardioMyopathy Substrate of Subjects With Ischemic CardioMyopathy

Completed NA Last updated 26 May 2022
What this trial tests

NA trial testing Low level tragus stimulation in Ischemic Cardiomyopathy in 26 participants. Completed in 30 March 2022.

Timeline
25 May 2018
Primary endpoint
30 June 2021
30 March 2022

Quick facts

Lead sponsorUniversity of Oklahoma
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment26
Start date25 May 2018
Primary completion30 June 2021
Estimated completion30 March 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Oklahoma

Who can join

Adults 18 to 90, any sex, with Ischemic Cardiomyopathy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Patients with ischemic cardiomyopathy (left ventricular ejection fraction \<35%) and heart failure who already have an implantable device with an atrial lead (dual chamber defibrillator or biventricular defibrillator) will undergo sequentially 1. Sham low level tragus stimulation (LLTS) (5min), 2. Active LLTS at 5Hz (15min) and 20Hz (15min) and 3. Active LLTS group with atrial pacing at 100bpm at 5Hz (15min) and 20Hz (15min). The latter is required to examine the effect of LLTS on RA independent of heart rate. Repolarization alternans will be measured by analyzing a regular 12-lead ECG using a custom-made software.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Ischemic Cardiomyopathy

Currently open trials in the same condition.

Other University of Oklahoma trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03549468.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing