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Supraventricular Tachycardia (SVT)Phase 4AVNRTstdyNCT07456423

Adenosine vs. Diltiazem

A Phase 4 study testing Adenosine intravenous and Diltiazem intravenous in people with Supraventricular Tachycardia (SVT) and Atrioventricular Nodal Re Entrant Tachycardia, run by Haseki Training and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Adenosine intravenous and Diltiazem intravenous
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jul 2024to 30 Aug 2025
Phase
Phase 4
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Haseki Training and Research Hospital

    Istanbul, Fatih, 34265

Other trials in Turkey (Türkiye)

About this study

Official title: Intravenous Adenosine Versus Diltiazem After Failed Modified Valsalva for Hemodynamically Stable ANVRT in the Emergency Department

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.

Read the detailed description

Supraventricular tachycardia (SVT) is a frequent cause of emergency department (ED) visits and typically presents as an abrupt-onset, regular tachycardia that can be highly symptomatic despite hemodynamic stability. Among regular narrow-complex SVTs, atrioventricular nodal re-entrant tachycardia (AVNRT) is one of the most common underlying mechanisms. Guidelines recommend modified Valsalva maneuver (MVM) as first-line therapy for hemodynamically stable regular narrow-complex SVT, followed by pharmacologic cardioversion when vagal maneuvers fail. However, while MVM has strengthened the non-pharmacologic first step, a clear emergency department (ED)-relevant comparative assessment of adenosine versus diltiazem specifically after failed MVM-with attention to conversion success, rescue therapy requirements, safety/tolerability, and clinically meaningful ED outcomes-remains warranted. This prospective, randomized, single-blind, single-center clinical trial evaluates the effectiveness of a standardized MVM and to compare the efficacy and adverse-event profiles of intravenous (IV) adenosine versus IV diltiazem among patients with persistent SVT after MVM. Consecutive adult patients with regular narrow-complex SVT consistent with AVNRT were randomized (1:1) to IV adenosine or IV diltiazem. Randomization was performed using a computer-generated sequence with allocation concealment (sequentially numbered, opaque, sealed envelopes). Treating clinicians were aware of group allocation in order to administer the assigned drug, whereas outcome assessors and the statistical team remained blinded throughout data collection and analysis. 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. 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. In patients who remained in SVT after protocolized dosing, subsequent management followed a predefined rescue algorithm based on hemodynamic status: hemodynamically stable patients received the alternative study drug (adenosine or diltiazem), whereas patients with signs of hemodynamic instability or persistent SVT despite sequential pharmacologic therapy underwent synchronized electrical cardioversion. In both groups, continuous clinical and electrocardiogram (ECG) monitoring was performed throughout the intervention period. For each eligible patient, baseline information was recorded at ED presentation, including age, sex, date/time of arrival, presenting symptoms, current medications, relevant comorbidities, and smoking and/or alcohol use history. Initial clinical and electrocardiographic data were documented, including heart rate, respiratory rate, systolic (SBP) and diastolic blood pressure (DBP), peripheral oxygen saturation (SpO2), and predefined ECG characteristics. In all patients who achieved sinus rhythm, vital signs (SBP/DBP, heart rate, and SpO2) were recorded immediately after conversion and at 10, 15, 30, and 60 minutes thereafter using standardized monitoring in the ED. The primary outcome was conversion to sinus rhythm with the allocated drug. Secondary outcomes included repeat dosing, time to conversion, adverse events, pause-related ECG events, crossover to the alternative drug, and disposition.

Being tested
Adenosine intravenous, Diltiazem intravenous
Keywords
supraventricular tachycardia, AVNRT, modified Valsalva maneuver, adenosine, diltiazem
Medical subject headings
Tachycardia, Supraventricular, Tachycardia, Atrioventricular Nodal Reentry

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adenosine intravenousDrug

    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.

  • Diltiazem intravenousDrug

    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.

Study groups in NCT07456423
Study groupRoleWhat they receive
Adenosine groupActive comparatorThe adenosine group received a rapid IV push of adenosine.
Receives: Drug: Adenosine intravenous
Diltiazem groupActive comparatorThe diltiazem group received an IV bolus of diltiazem.
Receives: Drug: Diltiazem intravenous

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Within 20 minutes after initiation of the assigned study drug

Secondary outcomes (3)
  1. Incidence of treatment-emergent adverse events and post-treatment ECG events assessed by continuous cardiac monitoring/ECG

    Treatment-emergent adverse events will be assessed using bedside clinical evaluation and patient-reported symptoms, and recorded prospectively on the study case report form. Prespecified adverse events include nausea, dyspnea, flushing, chest tightness, headache, and hypotension (blood pressure measured by standard noninvasive ED monitoring).

    Post-treatment ECG events will be assessed using continuous cardiac monitoring with rhythm strips, with documentation and review by a blinded outcome assessor. A pause-related event is defined as a transient absence of QRS complexes (ventricular pause) lasting ≥3 seconds on the monitor strip; sinus arrest is defined as a pause meeting the same duration threshold with absent P-wave activity consistent with sinus node suppression. Additional post-treatment rhythm findings (e.g., bradycardia, atrial flutter, atrial fibrillation) will be recorded if present.

    Measured: Within 2 hours following the initial study drug administration

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

    Time to conversion was defined as the elapsed time (in minutes) from initiation of the assigned study drug administration (IV adenosine or IV diltiazem) to the first documented sinus rhythm on continuous cardiac monitoring, confirmed by a rhythm strip and/or 12-lead ECG. If sinus rhythm was not achieved within the observation window, the participant was recorded as not converted within 60 minutes (time-to-conversion not achieved within the window).

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

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

    This outcome will be assessed using continuous ECG monitoring and bedside clinical evaluation during the ED observation period. A "rescue therapy" event will be recorded if a participant requires crossover to the alternative study drug (adenosine ↔ diltiazem) due to persistent SVT despite the protocolized dosing of the initially assigned drug. A "synchronized cardioversion" event will be recorded if synchronized electrical cardioversion is performed due to hemodynamic instability and/or persistent SVT despite sequential pharmacologic therapy, per the predefined rescue algorithm.

    Measured: 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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2026
  2. Study start1 Jul 2024
  3. Primary completion30 Jun 2025
  4. Study completion30 Aug 2025

Resources

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
Crossover
Model description
Single center
Masking
Single blind
Who is masked
Investigator
Enrolment
140 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07456423
Sponsor's protocol ID
28-2024
Acronym
AVNRTstdy
Status last verified
Mar 2026
First submitted
25 Feb 2026
Last updated
6 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Stored in non-publicly available Available on request

Publications

  • 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.

    PubMed 40618561
  • 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.

    PubMed 29025197
  • 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.

    PubMed 19261367
  • 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.

    PubMed 26314489
  • 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.

    PubMed 29239759
  • 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.

    PubMed 23050527

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Adenosine intravenous and Diltiazem intravenous in people with Supraventricular Tachycardia (SVT) and Atrioventricular Nodal Re Entrant Tachycardia, run by Haseki Training and Research Hospital at 1 site in Turkey (Türkiye).

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 5 inclusion and 4 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: finished, as of the sponsor's last update on 6 Mar 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 Turkey (Türkiye). 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Conversion to sinus rhythm on continuous cardiac monitor/ECG without rescue therapy (time frame: Within 20 minutes after initiation of the assigned study drug). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07456423, which also lists 6 linked publications.

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 6 Mar 2026.

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