Adenosine vs Diltiazem for Treatment of SVT in the ED
COMFORT-ED
COMparison of Adenosine Versus Diltiazem FOR Supraventricular Tachycardia in the ED (COMFORT-ED) - Pilot Trial
1 other identifier
interventional
20
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Aug 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 3, 2025
CompletedFirst Posted
Study publicly available on registry
May 28, 2025
CompletedStudy Start
First participant enrolled
August 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
September 11, 2025
August 1, 2025
11 months
April 3, 2025
September 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Feasibility outcome
Patients with stable SVT are identified in the ED (Threshold \>90%)
From enrollment to the end of ED encounter (up to 24 hours).
Feasibility outcome
Eligible participants who provide consent to participate (Threshold \>50%)
From enrollment to the end of ED encounter (up to 24 hours).
Feasibility outcome
Participants who complete all study procedures (Threshold \>80%)
From enrollment to the end of ED encounter (up to 24 hours).
Study Arms (2)
Adenosine
ACTIVE COMPARATORDiltiazem
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Adult patients (18 years and older)
- Diagnosis of acute, stable SVT in the emergency department
You may not qualify if:
- 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).
- Reported or confirmed personal history of Wolff-Parkinson-White (WPW) syndrome
- History of heart failure with reduce ejection fraction (HFrEF) (LVEF\</= 40%)
- Severe bronchoconstrictive lung disease
- Prior hypersensitivity to study medication
- Previously enrolled in pilot study
- Pregnant
- Incarcerated
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Anne E. Zepeskilead
Study Sites (1)
University of Iowa Health Care
Iowa City, Iowa, 52242, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anne Zepeski, PharmD
University of Iowa
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Clinical Assistant Professor
Study Record Dates
First Submitted
April 3, 2025
First Posted
May 28, 2025
Study Start
August 1, 2025
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
September 11, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share
We have no plans to share individual participant data, pursuant to local IRB approval and policies.