NCT06993038

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

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
7mo left

Started Aug 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress57%
Aug 2025Dec 2026

First Submitted

Initial submission to the registry

April 3, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 28, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

September 11, 2025

Status Verified

August 1, 2025

Enrollment Period

11 months

First QC Date

April 3, 2025

Last Update Submit

September 4, 2025

Conditions

Keywords

diltiazemadenosineemergency medicine

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 COMPARATOR
Drug: adenosine

Diltiazem

ACTIVE COMPARATOR
Drug: diltiazem

Interventions

IV adenosine at standard doses for SVT (6 mg, 12 mg)

Adenosine

IV diltiazem at standard doses for SVT (0.25 mg/kg)

Diltiazem

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

University of Iowa Health Care

Iowa City, Iowa, 52242, United States

RECRUITING

MeSH Terms

Conditions

Tachycardia, Supraventricular

Interventions

AdenosineDiltiazem

Condition Hierarchy (Ancestors)

TachycardiaArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Purine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosidesBenzazepines

Study Officials

  • Anne Zepeski, PharmD

    University of Iowa

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne Zepeski, PharmD

CONTACT

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.

Locations