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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
NA trial testing Low level tragus stimulation in Ischemic Cardiomyopathy in 26 participants. Completed in 30 March 2022.
30 June 2021
Quick facts
| Lead sponsor | University of Oklahoma |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 26 |
| Start date | 25 May 2018 |
| Primary completion | 30 June 2021 |
| Estimated completion | 30 March 2022 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Low level tragus stimulation
Conditions studied
- Ischemic Cardiomyopathy — all drugs for Ischemic Cardiomyopathy →
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:
- PubMed search for NCT03549468
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03549468 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Oklahoma
- Last refreshed: 26 May 2022
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