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临床试验/NCT07456423
NCT07456423已完成4 期

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

Haseki Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2024年7月1日最近更新:
干预措施

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
140
试验地点
1
主要终点
Conversion to sinus rhythm on continuous cardiac monitor/ECG without rescue therapy

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Investigator)

盲法说明

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.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)
  • Hemodynamic instability or respiratory failure requiring emergency intubation and advanced life support

研究组 & 干预措施

Adenosine group

Active Comparator

The adenosine group received a rapid IV push of adenosine.

干预措施: Adenosine intravenous (Drug)

Diltiazem group

Active Comparator

The diltiazem group received an IV bolus of diltiazem.

干预措施: Diltiazem intravenous (Drug)

结局指标

主要结局

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

时间窗: Within 20 minutes after initiation of the assigned study drug

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.

次要结局

  • 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).)

研究者

发起方
Haseki Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Adem Az

Principal Investigator

Haseki Training and Research Hospital

研究点 (1)

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