Adenosine vs. Diltiazem

NCT07456423 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: 28-2024
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

In this Emergency Department (ED)-based study, the investigators evaluated a standardized modified Valsalva maneuver (MVM) as first-line therapy and compared intravenous (IV) adenosine with IV diltiazem among patients with persistent atrioventricular nodal re-entrant tachycardia (AVNRT)-consistent supraventricular tachycardia (SVT) after MVM, focusing on successful conversion to sinus rhythm. The investigators also assessed drug-related adverse events and clinically relevant treatment-course measures.

Conditions

Supraventricular Tachycardia (SVT); Atrioventricular Nodal Re Entrant Tachycardia

Keywords

supraventricular tachycardia; AVNRT; modified Valsalva maneuver; adenosine; diltiazem

Outcome Measures

Primary Outcomes (1)

• Conversion to sinus rhythm on continuous cardiac monitor/ECG without rescue therapy

  The outcome was cardiac rhythm (sinus rhythm vs persistent SVT) assessed using continuous ECG monitoring. Conversion was defined as sinus rhythm documented on the monitor and confirmed by a rhythm strip and/or 12-lead ECG, adjudicated by a blinded outcome assessor. "Successful conversion" required conversion with the randomized, initially assigned drug regimen (IV adenosine vs IV diltiazem) without crossover to the alternative drug, synchronized cardioversion, or other rescue therapy within the outcome time window.

  Within 20 minutes after initiation of the assigned study drug

Secondary Outcomes (3)

• Incidence of treatment-emergent adverse events and post-treatment ECG events assessed by continuous cardiac monitoring/ECG

  Within 2 hours following the initial study drug administration

• Time to conversion to sinus rhythm (minutes) assessed by continuous ECG monitoring

  Up to 60 minutes following the initial study drug administration (conversion time/status documented at 10, 15, 30, and 60 minutes)

• Need for rescue therapy (crossover to the alternative study drug) or synchronized electrical cardioversion

  During the acute ED observation period, up to 60 minutes after initiation of the initially assigned study drug (or earlier if synchronized cardioversion is required).

Study Arms (2)

Adenosine group

ACTIVE COMPARATOR

The adenosine group received a rapid IV push of adenosine.

Drug: Adenosine intravenous

Diltiazem group

ACTIVE COMPARATOR

The diltiazem group received an IV bolus of diltiazem.

Drug: Diltiazem intravenous

Interventions

Adenosine intravenous DRUG

Adenosine was administered as a rapid IV push (6 mg over \~2 seconds) followed immediately by a 10-mL normal saline flush; the injected arm was briefly elevated to facilitate rapid central delivery. If tachycardia persisted and no rhythm conversion occurred within 1-2 minutes, additional doses of 12 mg and then 18 mg were administered using the same technique, per the study protocol.

Adenosine group

Diltiazem intravenous DRUG

Diltiazem was administered intravenously as 0.25 mg/kg (maximum 20 mg) over approximately 2 minutes. If tachycardia persisted, a second dose of 0.35 mg/kg (maximum 25 mg) was administered after \~15 minutes.

Diltiazem group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Presentation to the emergency department with hemodynamically stable, regular narrow-complex SVT consistent with AVNRT
• a regular narrow-complex tachycardia with QRS duration \<120 ms
• no discernible P waves on the presenting rhythm strip or 12-lead ECG
• a ventricular rate of 160-220 beats/min

You may not qualify if:

• Contraindications to adenosine or diltiazem (known hypersensitivity to adenosine or diltiazem, prior heart transplantation, or concomitant dipyridamole/carbamazepine therapy)
• Clinical evidence of impaired cerebral perfusion (e.g., altered mental status)
• Pegnancy
• Hemodynamic instability or respiratory failure requiring emergency intubation and advanced life support

Sponsors & Collaborators

• Haseki Training and Research Hospital: lead

Study Sites (1)

Haseki Training and Research Hospital

Istanbul, Fatih, 34265, Turkey (Türkiye)

Location

Related Publications (6)

• Lee CA, Morrissey B, Chao K, Healy J, Ku K, Khan M, Kinteh E, Shedd A, Garrett J, Chou EH. Adenosine Versus Fixed-Dose Intravenous Bolus Diltiazem on Reversing Supraventricular Tachycardia in The Emergency Department: A Multi-Center Cohort Study. J Emerg Med. 2025 Aug;75:55-64. doi: 10.1016/j.jemermed.2025.05.020. Epub 2025 Jun 6.

  PMID: 40618561 RESULT

• Alabed S, Sabouni A, Providencia R, Atallah E, Qintar M, Chico TJ. Adenosine versus intravenous calcium channel antagonists for supraventricular tachycardia. Cochrane Database Syst Rev. 2017 Oct 12;10(10):CD005154. doi: 10.1002/14651858.CD005154.pub4.

  PMID: 29025197 RESULT

• Lim SH, Anantharaman V, Teo WS, Chan YH. Slow infusion of calcium channel blockers compared with intravenous adenosine in the emergency treatment of supraventricular tachycardia. Resuscitation. 2009 May;80(5):523-8. doi: 10.1016/j.resuscitation.2009.01.017. Epub 2009 Mar 3.

  PMID: 19261367 RESULT

• Appelboam A, Reuben A, Mann C, Gagg J, Ewings P, Barton A, Lobban T, Dayer M, Vickery J, Benger J; REVERT trial collaborators. Postural modification to the standard Valsalva manoeuvre for emergency treatment of supraventricular tachycardias (REVERT): a randomised controlled trial. Lancet. 2015 Oct 31;386(10005):1747-53. doi: 10.1016/S0140-6736(15)61485-4. Epub 2015 Aug 24.

  PMID: 26314489 RESULT

• Brubaker S, Long B, Koyfman A. Alternative Treatment Options for Atrioventricular-Nodal-Reentry Tachycardia: An Emergency Medicine Review. J Emerg Med. 2018 Feb;54(2):198-206. doi: 10.1016/j.jemermed.2017.10.003. Epub 2017 Nov 26.

  PMID: 29239759 RESULT

• Link MS. Clinical practice. Evaluation and initial treatment of supraventricular tachycardia. N Engl J Med. 2012 Oct 11;367(15):1438-48. doi: 10.1056/NEJMcp1111259. No abstract available.

  PMID: 23050527 RESULT

MeSH Terms

Conditions

Tachycardia, Supraventricular; Tachycardia, Atrioventricular Nodal Reentry

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Tachycardia, Reciprocating

Study Officials

• Adem Az

  Haseki Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Patients were randomly assigned to the adenosine or diltiazem groups using a web-based computer-generated randomization service (https://www.randomizer.org/). Allocation concealment was ensured using sequentially numbered, opaque, sealed envelopes (SNOSE). Envelopes were prepared and sealed according to the randomization list and opened sequentially after eligibility had been confirmed and written informed consent obtained.Clinicians administering the interventions were not blinded to treatment allocation but were not involved in outcome assessment or data analysis. Outcome assessors and the statistical team were blinded to treatment assignment. Treatment codes were accessible only in emergency safety situations requiring unblinding, and such cases were documented according to the study protocol. All primary analyses were conducted according to the intention-to-treat (ITT) principle, with per-protocol analyses reported as sensitivity analyses.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Single center

Study Record Dates

• First Submitted: February 25, 2026
• First Posted: March 6, 2026
• Study Start: July 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: August 30, 2025
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)