Adenosine vs Diltiazem for Treatment of SVT in the ED

NCT06993038 — Phase 4, Recruiting, 20 participants, Anne E. Zepeski

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COMparison of Adenosine Versus Diltiazem FOR Supraventricular Tachycardia in the ED (COMFORT-ED) - Pilot Trial

Registry	NCT06993038, acronym COMFORT-ED
Status	Recruiting
Phase	Phase 4
Study type	Interventional; randomized, single group, masking: single, treatment
Enrollment	20 (Estimated)
Sponsor	Anne E. Zepeski (Other)
Conditions	Supraventricular Tachycardia (SVT)
Interventions	adenosine, diltiazem (Drug)
Dates	start 2025-08-01, primary completion 2027-07-01 (estimated), completion 2027-12-01 (estimated), first posted 2025-05-28, last updated 2026-05-28
Locations	1 site in United States

-Summary

This is a small, pilot study with a primary goal of assessing patient perceptions of two medication treatments for supraventricular tachycardia in adult patients treated in the Emergency Department.

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+Arms and interventions

Arm	Type	Interventions	Description
Adenosine	Active comparator	Drug: adenosine
Diltiazem	Active comparator	Drug: diltiazem

adenosine (Drug): IV adenosine at standard doses for SVT (6 mg, 12 mg)
diltiazem (Drug): IV diltiazem at standard doses for SVT (0.25 mg/kg)

+Outcome measures

Primary outcomes

Feasibility outcome [From enrollment to the end of ED encounter (up to 24 hours).]: Patients with stable SVT are identified in the ED (Threshold >90%)
Feasibility outcome [From enrollment to the end of ED encounter (up to 24 hours).]: Eligible participants who provide consent to participate (Threshold >50%)
Feasibility outcome [From enrollment to the end of ED encounter (up to 24 hours).]: Participants who complete all study procedures (Threshold >80%)

+Eligibility

Sex: All, ages: 18 Years to 100 Years

Inclusion Criteria:

1. Adult patients (18 years and older)
2. Diagnosis of acute, stable SVT in the emergency department

Exclusion Criteria:

1. Receipt of IV AV-nodal blocking agents prior to study enrollment (includes adenosine, non-dihydropyridine calcium channel blockers, beta-antagonists in pre-hospital and/or hospital setting).
2. Reported or confirmed personal history of Wolff-Parkinson-White (WPW) syndrome
3. History of heart failure with reduce ejection fraction (HFrEF) (LVEF</= 40%)
4. Severe bronchoconstrictive lung disease
5. Prior hypersensitivity to study medication
6. Previously enrolled in pilot study
7. Pregnant
8. Incarcerated

+Locations (1)

Facility	City	Country	Status
University of Iowa Health Care	Iowa City, Iowa	United States	Recruiting

+Investigators

Anne Zepeski, PharmD, Principal investigator, University of Iowa