Clinical trial NCT06717685: Efficacy of Adenosine as Compared to Verapamil in Paroxysmal Supraventricular Tachycardia (pSVT) Patients
Official title: Comparison of Verapamil With Adenosine After Vagal Maneuvers in Patients Presenting With Paroxysmal Supraventricular Tachycardia (pSVT), in a Tertiary Care Hospital of Lahore, Pakistan
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Supraventricular Tachycardia (SVtach)
Keywords: Ventricular
Tachycardia
Lead sponsor: Rashid Latif Medical College
Sponsor class: OTHER
Collaborators: name: Punjab Institute of Cardology
name: Himmel Pharmaceutical private limited, Pakistan
First posted: 2024-12-05
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Standard Valsalva maneuver or modified Valsalva maneuver will be attempted on patients according to their allocation of groups. After Three attempts with 5 minutes interval between each attempt if normal sinus rhythm was not achieved. IV pharmacological intervention will made. it includes Injection verapamil 5 mg or adenosine. Each patient will be kept under observation for one hour after normalization of sinus rhythm.
Primary purpose: TREATMENT

Brief summary: Supraventricular tachycardia (SVT) is a term widely used to describe tachycardial dysrhythmias, paroxysmal SVT (PSVT) is a narrow term including only AV nodal re-entrant tachycardia (AVNRT) and atrioventricular re-entrant tachycardia (AVRT), both of which can cause discomfort and, in some cases, life-threatening symptoms.

Usually Carotid sinus massage is done to lower the pulse rate and after the standard time specific verapamil dose is administered. In this study after carotid sinus massage Conventional Valsalva or modified Valsalva maneuver will be randomly applied. In case, the normal sinus rhythm (NSR) is not achieved then verapamil of or adenosine dose will be administered to the patients after after taking the consent.

Detailed description: Supraventricular tachycardia (SVT) is a term widely used to describe tachycardial dysrhythmias, paroxysmal SVT (PSVT) is a narrow term including only AV nodal re-entrant tachycardia (AVNRT) and atrioventricular re-entrant tachycardia (AVRT), both of which can cause discomfort and, in some cases, life-threatening symptoms. The incidence of PSVT is approximately 1 in 300 and this prevalence increases with age.

Maneuvers that increase vagus activity have been used to terminate PSVT. Vagal maneuvers reduce the rate of stimulation of the sinus node, slow the rate of delivery to the atrioventricular node, and prolong the refractory period. Vagal-maneuver techniques include carotid sinus massage, the diving reflex, the oculocardiac reflex, and Valsalva maneuvers. Because vagal maneuvers are a non-invasive technique, recent guidelines recommend them as a first-line treatment before medical intervention to terminate PSVT.

Since the 17th century, the Valsalva maneuver (VM) has been used in daily practice and aims to challenge the individual with forced expiration while the glottis is closed, or exhalation to raise the mercury column in tubing of standard manometer to 40 mmHg. 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 success of VM. In addition, several studies and case reports have shown that VM with simple, safe modifications (modified VM) is more effective in terminating PSVT. These modifications include pressing the epigastric zone or abdomen for 10 seconds after VM; changing position quickly, such as from being seated to supine; or lifting the feet at a 45-degree angle just after the VM.

Efficacy of SVM in restoring sinus rhythm is less than 25% while of Modified Valsalva maneuver (MVM)) has showed higher efficacy (\> 40%).6 However, few studies have evaluated the success rate of modified VM. Therefore, the present randomized controlled study aimed to detect whether modified VM is more effective than standard VM in terminating PSVT.

Eligibility criteria: Inclusion Criteria:

* Stable SVT (not requiring cardioversion, fully conscious, maintaining systolic blood pressure of \>90mmHg)
* Alert enough and able to give consent
* Able to lie flat and non-painful legs during passive leg raising

Exclusion Criteria:

* Unstable SVT (Semiconscious, drowsy, breathless, systolic BP \<90mmHg)
* Not able to give consent
* Orthopnea causing inability to lie flat
* Atrial fibrillation/atrial flutter
* Recent MI (within last 7 days)
* Ongoing ischemia as indicated by chest pain or ST segment depression/elevation in ECG
* Aortic stenosis
* All trimesters of pregnancy

Primary outcomes:
measure: achieve the normal sinus rhythm
timeFrame: 24 to 36 hours
Secondary outcomes:
measure: Efficacy of standard or modified vagal maneuver
timeFrame: 10 minutes
measure: Efficacy of IV verapamil and IV adenosine
timeFrame: 30 to 60 minutes
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Punjab Institute of Cardiology
state: Punjab
Study officials:
affiliation: Punjab Institute of Cardiology
name: Hafiz Abdul Manan Shahid, FCPS
role: STUDY_DIRECTOR
References:
citation: Corbacioglu SK, Akinci E, Cevik Y, Aytar H, Oncul MV, Akkan S, Uzunosmanoglu H. Comparing the success rates of standard and modified Valsalva maneuvers to terminate PSVT: A randomized controlled trial. Am J Emerg Med. 2017 Nov;35(11):1662-1665. doi: 10.1016/j.ajem.2017.05.034. Epub 2017 May 22.
citation: Rehorn M, Sacks NC, Emden MR, Healey B, Preib MT, Cyr PL, Pokorney SD. Prevalence and incidence of patients with paroxysmal supraventricular tachycardia in the United States. J Cardiovasc Electrophysiol. 2021 Aug;32(8):2199-2206. doi: 10.1111/jce.15109. Epub 2021 Jun 14.
citation: Page RL, Joglar JA, Caldwell MA, Calkins H, Conti JB, Deal BJ, Estes NA III, Field ME, Goldberger ZD, Hammill SC, Indik JH, Lindsay BD, Olshansky B, Russo AM, Shen WK, Tracy CM, Al-Khatib SM. 2015 ACC/AHA/HRS guideline for the management of adult patients with supraventricular tachycardia: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society. Heart Rhythm. 2016 Apr;13(4):e136-221. doi: 10.1016/j.hrthm.2015.09.019. Epub 2015 Sep 25. No abstract available.
citation: Ceylan E, Ozpolat C, Onur O, Akoglu H, Denizbasi A. Initial and Sustained Response Effects of 3 Vagal Maneuvers in Supraventricular Tachycardia: A Randomized, Clinical Trial. J Emerg Med. 2019 Sep;57(3):299-305. doi: 10.1016/j.jemermed.2019.06.008. Epub 2019 Aug 20.
citation: 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.