20 Participants Needed

Adenosine vs Diltiazem for SVT

(COMFORT-ED Trial)

AZ
Overseen ByAnne Zepeski, PharmD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores patient experiences with two medications, adenosine and diltiazem, used to treat supraventricular tachycardia (SVT), a type of rapid heartbeat. Researchers aim to understand patient experiences when treated in the Emergency Department. Adults diagnosed with acute, stable SVT who have not received certain heart medications before enrolling may be suitable for this study. As a Phase 4 trial, this research focuses on understanding how these FDA-approved treatments benefit a broader range of patients.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop your current medications, but you cannot have received certain heart medications like adenosine or beta-blockers before joining.

What is the safety track record for these treatments?

Research has shown that both adenosine and diltiazem are generally safe for treating supraventricular tachycardia (SVT), a fast heartbeat. Studies indicate that adenosine does not cause additional harm, even in patients with other health issues, suggesting it is well-tolerated. One study found that diltiazem also has few side effects and helps restore normal heart rhythm. Both medications are commonly used, and past research supports their safety. Thus, they are widely accepted as safe options for managing SVT.12345

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the treatments adenosine and diltiazem for supraventricular tachycardia (SVT) because each offers distinct approaches to managing this condition. Adenosine is unique because it acts rapidly, often stopping SVT within seconds by temporarily blocking the conduction of electrical impulses through the heart’s AV node, essentially resetting the heart rhythm. Diltiazem, on the other hand, is a calcium channel blocker that slows down the heart rate by reducing calcium influx into heart cells, offering a more sustained control of heart rhythm compared to the immediate response from adenosine. These differing mechanisms provide valuable options for personalized treatment, giving physicians flexibility based on the patient's specific needs and response.

What evidence suggests that this trial's treatments could be effective for supraventricular tachycardia?

This trial will compare the effectiveness of adenosine and diltiazem in treating supraventricular tachycardia (SVT). Research has shown that both adenosine and diltiazem effectively treat this condition. Studies indicate that adenosine, administered to participants in one arm of this trial, often works faster and more successfully, quickly helping the heart return to a normal rhythm. A higher dose of adenosine, such as 12 mg, can improve results in emergency situations. Meanwhile, diltiazem, given to participants in another arm, is also effective. One study showed it stopped SVT in 86% of patients by slowing down or stopping the abnormal heart rhythm. Both treatments are well-regarded and have proven effective for SVT.12567

Who Is on the Research Team?

AZ

Anne Zepeski, PharmD

Principal Investigator

University of Iowa

Are You a Good Fit for This Trial?

Adults aged 18 and older diagnosed with acute, stable Supraventricular Tachycardia (SVT) who are being treated in the Emergency Department can participate. Specific details on who cannot join were not provided.

Inclusion Criteria

I was diagnosed with a stable, sudden heart rhythm issue in the ER.
I am 18 years old or older.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 24 hours

Treatment

Participants receive either Adenosine or Diltiazem for treatment of supraventricular tachycardia in the Emergency Department

Up to 24 hours

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 24 hours

What Are the Treatments Tested in This Trial?

Interventions

  • Adenosine
  • Diltiazem
Trial Overview This pilot study is comparing patient perceptions of two medications for SVT: adenosine and diltiazem. It aims to understand which treatment patients prefer when given in the Emergency Department setting.
How Is the Trial Designed?
2Treatment groups
Active Control
Group I: AdenosineActive Control1 Intervention
Group II: DiltiazemActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Anne E. Zepeski

Lead Sponsor

Citations

A meta-analysis utilizing BioMedGPT-LM-7BOur data demonstrated that both adenosine/ATP and CCBs exhibit remarkable efficacy in treating SVT, with no notable difference in effectiveness ...
2.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/40055614/
A meta-analysis utilizing BioMedGPT-LM-7BClinical studies indicate that adenosine has a higher success rate and faster conversion time in restoring sinus rhythm compared to ATP, with ...
Study Details | NCT06717685 | Efficacy of Adenosine as ...In clinical practice, VM has varied success rates (5-20%) in terminating PSVT. It has been found that the patient's posture is an important factor affecting the ...
Comparison of initial adenosine dose conversion rate for ...A higher rate of SVT termination was observed with an initial adenosine dose of 12 mg in the ED in comparison to the guideline recommended dose of 6 mg.
Prehospital Adenosine for SVT – 6 or 12 mg?After adjustment, an initial dose of 12 mg was associated with 65% increased odds of prehospital improvement (OR 1.65, 95%CI 1.49-1.82), higher ...
Prehospital management of supraventricular tachycardia: a ...Both adenosine and ECV were effective and safe, with ECV being more effective in unstable patients but requiring more sedatives. The results of this study, ...
7.jdc.jefferson.edujdc.jefferson.edu/medfp/405/
"Safety of Adenosine for the Treatment of Supraventricular ...In this study, there was no evidence of increased harm from administering adenosine to patients with SVT and COVID-19. This finding needs to be confirmed in ...
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