Supraventricular Tachycardia (SVT)Phase 4COMFORT-EDNCT06993038
Adenosine vs Diltiazem for Treatment of SVT in the ED
A Phase 4 study testing adenosine and diltiazem in people with Supraventricular Tachycardia (SVT), run by Anne E. Zepeski at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Supraventricular Tachycardia (SVT)
- What is being tested?
- adenosine and diltiazem
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2025to Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (18 years and older)
- Diagnosis of acute, stable SVT in the emergency department
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Iowa Health Care
Iowa City, Iowa, 52242
Anne Zepeski, PhamD, 651-207-9357, anne-zepeski@uiowa.edu
About this study
Official title: COMparison of Adenosine Versus Diltiazem FOR Supraventricular Tachycardia in the ED (COMFORT-ED) - Pilot Trial
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.
- Conditions
- Supraventricular Tachycardia (SVT)
- Being tested
- adenosine, diltiazem
- Keywords
- diltiazem, adenosine, emergency medicine
- Medical subject headings
- Tachycardia, Supraventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adenosineDrug
IV adenosine at standard doses for SVT (6 mg, 12 mg)
diltiazemDrug
IV diltiazem at standard doses for SVT (0.25 mg/kg)
| Study group | Role | What they receive |
|---|---|---|
| Adenosine | Active comparator | Not described Receives: Drug: adenosine |
| Diltiazem | Active comparator | Not described Receives: Drug: diltiazem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility outcome
Patients with stable SVT are identified in the ED (Threshold >90%)
Measured: From enrollment to the end of ED encounter (up to 24 hours).
Feasibility outcome
Eligible participants who provide consent to participate (Threshold >50%)
Measured: From enrollment to the end of ED encounter (up to 24 hours).
Feasibility outcome
Participants who complete all study procedures (Threshold >80%)
Measured: From enrollment to the end of ED encounter (up to 24 hours).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start1 Aug 2025
- Primary completionJul 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Supraventricular Tachycardia (SVT)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anne E. Zepeski
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anne E. Zepeski, University of Iowa
- Investigators
- Anne Zepeski, PharmD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06993038
- Sponsor's protocol ID
- 202412202
- Acronym
- COMFORT-ED
- Status last verified
- May 2026
- First submitted
- 3 Apr 2025
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: We have no plans to share individual participant data, pursuant to local IRB approval and policies.
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMparison of Adenosine Versus Diltiazem FOR Supraventricular Tachycardia in the ED (COMFORT-ED) - Pilot Trial
- ClinicalTrials.gov ID
- NCT06993038
- Acronym / sponsor ID
- COMFORT-ED / 202412202
- Conditions
- Supraventricular Tachycardia (SVT)
- Keywords
- diltiazem, adenosine, emergency medicine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Anne E. ZepeskiUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 28 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adenosine | Active comparator | Drug: adenosine |
| Diltiazem | Active comparator | Drug: diltiazem |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients (18 years and older)
- Diagnosis of acute, stable SVT in the emergency department
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| adenosineIV adenosine at standard doses for SVT (6 mg, 12 mg) | Drug | Adenosine |
| diltiazemIV diltiazem at standard doses for SVT (0.25 mg/kg) | Drug | Diltiazem |
Primary outcome
Feasibility outcome
Time frame: 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
Time frame: From enrollment to the end of ED encounter (up to 24 hours).
Eligible participants who provide consent to participate (Threshold >50%)
Feasibility outcome
Time frame: From enrollment to the end of ED encounter (up to 24 hours).
Participants who complete all study procedures (Threshold >80%)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: No. We have no plans to share individual participant data, pursuant to local IRB approval and policies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anne Zepeski, PharmD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing adenosine and diltiazem in people with Supraventricular Tachycardia (SVT), run by Anne E. Zepeski at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne Zepeski, PharmD ((319) 356-2577, anne-zepeski@uiowa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility outcome (time frame: From enrollment to the end of ED encounter (up to 24 hours).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.