First Randomized, Multicenter, Placebo-Controlled Study of Self-Administered Intranasal Etripamil for Acute Conversion of Spontaneous Paroxysmal Supraventricular Tachycardia (NODE-301)

Bruce S. Stambler; Francis Plat; Philip T. Sager; Silvia Shardonofsky; Douglas Wight; Diane Potvin; A. Shekhar Pandey; James E. Ip; Benoit Coutu; Blandine Mondésert; Laurence D. Sterns; Matthew T. Bennett; Jeffrey L. Anderson; Roger S. Damle; Ronald J. Haberman; A. John Camm

doi:10.1161/circep.122.010915

November 28, 2022Circulation Arrhythmia and ElectrophysiologyOpen Access

First Randomized, Multicenter, Placebo-Controlled Study of Self-Administered Intranasal Etripamil for Acute Conversion of Spontaneous Paroxysmal Supraventricular Tachycardia (NODE-301)

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Why the study?

Pharmacologic termination of PSVT often requires medically supervised intervention, creating a need for treatments designed for unsupervised self-administration.

Does self-administered intranasal etripamil 70 mg improve termination of adjudicated PSVT within 5 hours in patients with symptomatic sustained PSVT?

Structured PICO

Does self-administered intranasal etripamil 70 mg improve termination of adjudicated PSVT within 5 hours in patients with symptomatic sustained PSVT?

P

Population

Patients with symptomatic sustained paroxysmal supraventricular tachycardia (PSVT)

I

Intervention

Etripamil 70 mg nasal spray, self-administered unsupervised when PSVT symptoms persisted after vagal maneuver

C

Comparator

Placebo nasal spray

O

Outcome

Termination of adjudicated PSVT within 5 hours after study drug administrationsurrogate

Self-administered intranasal etripamil did not meet the primary 5-hour endpoint for terminating PSVT, but showed potential efficacy at earlier time points and was well tolerated.

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Implication

Etripamil fails the primary 5-hour PSVT endpoint; leaves open possible earlier termination for targeted trials.

Abstract

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Cite This Study

Stambler et al. (2022) studied this question.

synapsesocial.com/papers/69f69186c2e2af4931440630 https://doi.org/10.1161/circep.122.010915

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First Randomized, Multicenter, Placebo-Controlled Study of Self-Administered Intranasal Etripamil for Acute Conversion of Spontaneous Paroxysmal Supraventricular Tachycardia (NODE-301)

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Structured PICO

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Implication

Abstract

Discussion

Cite This Study

First Randomized, Multicenter, Placebo-Controlled Study of Self-Administered Intranasal Etripamil for Acute Conversion of Spontaneous Paroxysmal Supraventricular Tachycardia (NODE-301)

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Structured PICO

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Implication

Abstract

Discussion

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