Efficacy of Adenosine as Compared to Verapamil in Paroxysmal Supraventricular Tachycardia (pSVT) Patients

NCT06717685 | Recruiting Phase 3 FDA Drug

• 1 other identifier: PIC001/2024
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

Supraventricular Tachycardia (SVtach)

Keywords

Ventricular; Tachycardia

Outcome Measures

Primary Outcomes (1)

• achieve the normal sinus rhythm

  As the patient came to ER blood pressure and primary information will be collected by the in-charge nurse. then treatment will be provided in following steps First; carotid message will be done. Supraventricular tachycardia (SVT) reverted to normal sinus rhythm (NSR), And if NSR not achieved, Vagal maneuver as mentioned in methodology will be performed, And if NSR not achieved, Randomly, IV verapamil or adenosine will be injected. After achieving NSR the patient will be kept under observation for 30 min after that the patient will be asked to visit the Outpatient department (OPD) in the next working day.

  24 to 36 hours

Secondary Outcomes (2)

• Efficacy of standard or modified vagal maneuver

  10 minutes

• Efficacy of IV verapamil and IV adenosine

  30 to 60 minutes

Study Arms (3)

Group A: Conventional Valsalva

EXPERIMENTAL

Performance of forced expiration in the standard manometer tubing to generate a pressure of 40 mmHg for 15 seconds while lying on back or sitting position.

Drug: Adenosine

Group B: Modified Valsalva Maneuver

EXPERIMENTAL

Patient will be placed in semi-recumbent position and instructed to exhale forcefully in manometer to generate pressure of 40 mmHg for 15 seconds, immediately followed by supine repositioning of the bed, and simultaneous passive leg raising to 45 degree with the help of one assistant standing on the foot side, for 15 seconds.

Drug: Adenosine

Group C: Modified Valsalva Maneuver

ACTIVE COMPARATOR

Patient will be placed in semi-recumbent position and instructed to exhale forcefully in manometer to generate pressure of 40 mmHg for 15 seconds, immediately followed by supine repositioning of the bed, and simultaneous passive leg raising to 45 degree with the help of one assistant standing on the foot side, for 15 seconds.

Drug: Verapamil Injection

Interventions

Adenosine DRUG

Adenosine is a medication belonging to class V antidysrhythmics, used to treat a type of irregular heart rhythm disorder known as paroxysmal supraventricular tachycardia (PSVT)

Group A: Conventional Valsalva; Group B: Modified Valsalva Maneuver

Verapamil Injection DRUG

Verapamil is in a class of medications called calcium-channel blockers. It works by relaxing the blood vessels so the heart does not have to pump as hard. It also increases the supply of blood and oxygen to the heart and slows electrical activity in the heart to control the heart rate.

Also known as: Verapamil

Group C: Modified Valsalva Maneuver

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rashid Latif Medical College: lead
• Punjab Institute of Cardology: collaborator
• Himmel Pharmaceutical private limited, Pakistan: collaborator

Study Sites (1)

Punjab Institute of Cardiology

Lahore, Punjab Province, Pakistan

RECRUITING

Related Publications (5)

• 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.

  PMID: 28552271 BACKGROUND

• 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.

  PMID: 34028109 BACKGROUND

• 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.

  PMID: 26409100 BACKGROUND

• 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.

  PMID: 31443919 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Tachycardia, Supraventricular; Tachycardia

Interventions

Adenosine; Verapamil

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Study Officials

• Hafiz Abdul Manan Shahid, FCPS

  Punjab Institute of Cardiology

  STUDY DIRECTOR

Central Study Contacts

Abdul Manan Shahid, FCPS

CONTACT

+923336302776; dr_hams79@yahoo.com

Arslan Saleem Chughtai, M.Phil.

CONTACT

+923334585339; arslan.chughtai@rlmc.edu.pk

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Modified Valsalva with adenosine will be administered on Monday and Tuesday Conventional Valsalva with adenosine will be administered on Wednesday and Thursday Modified Valsalva with verapamil will be administered on Friday and Saturday
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Biostatistician

Model Details: 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.

Study Record Dates

• First Submitted: October 12, 2024
• First Posted: December 5, 2024
• Study Start: October 28, 2024
• Primary Completion: January 27, 2025
• Study Completion: February 3, 2025
• Last Updated: December 13, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)