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Supraventricular Tachycardia (SVtach)Phase 3NCT06717685

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

A Phase 3 study testing Adenosine and Verapamil Injection in people with Supraventricular Tachycardia (SVtach), run by Rashid Latif Medical College at 1 site in Pakistan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Supraventricular Tachycardia (SVtach)
What is being tested?
Adenosine and Verapamil Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
210 participants
Where
1 sitePakistan
Study dates
28 Oct 2024to 3 Feb 2025
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Abdul Manan Shahid, FCPS contact

+923336302776

dr_hams79@yahoo.com

Arslan Saleem Chughtai, M.Phil. contact

+923334585339

arslan.chughtai@rlmc.edu.pk

Pakistan1 site, 1 recruiting
  • Punjab Institute of Cardiology

    Lahore, Punjab Province

    Abdul Manan Shahid, FCPS, +923336302776, dr_hams79@yahoo.com

    Sadaf Naeem, FCPS, +92 3414135231

    Recruiting

Other trials in Pakistan

About this study

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

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.

Read the 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.

Being tested
Adenosine, Verapamil Injection
Keywords
Ventricular, Tachycardia
Medical subject headings
Tachycardia, Supraventricular, Tachycardia

What participants receive

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

  • AdenosineDrug

    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)

  • Verapamil InjectionDrug

    Also called Verapamil

    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.

Study groups in NCT06717685
Study groupRoleWhat they receive
Group A: Conventional ValsalvaExperimentalPerformance 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.
Receives: Drug: Adenosine
Group B: Modified Valsalva ManeuverExperimentalPatient 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.
Receives: Drug: Adenosine
Group C: Modified Valsalva ManeuverActive comparatorPatient 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.
Receives: Drug: Verapamil Injection

What is being measured

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

  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.

    Measured: 24 to 36 hours

Secondary outcomes (2)
  1. Efficacy of standard or modified vagal maneuver

    Frequency of the patients achieved NSR after standard or modified maneuver will be analyzed for efficacy.

    Measured: 10 minutes

  2. Efficacy of IV verapamil and IV adenosine

    carotid message will be done to revert SVT to NSR, Or/And if NSR not achieved Second; Vagal maneuver will be performed, Or/And if NSR not achieved Third, Randomly, IV verapamil or adenosine will be injected in two phases. After achieving NSR the patient will be kept under observation for 30 min.

    Measured: 30 to 60 minutes

Timeline

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

  1. First posted5 Dec 2024
  2. Study start28 Oct 2024
  3. Primary completion27 Jan 2025 (estimated)
  4. Study completion3 Feb 2025 (estimated)

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Single blind
Who is masked
Participant
Enrolment
210 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06717685
Sponsor's protocol ID
PIC001/2024
Status last verified
Dec 2024
First submitted
12 Oct 2024
Last updated
13 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: A unique MRN will be assigned to anonymize the patient data. Study director will be the custodian of the data. generalized results will be presented in the conferences and publications

Publications

  • 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.

    PubMed 28552271
  • 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.

    PubMed 34028109
  • 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.

    PubMed 26409100
  • 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.

    PubMed 31443919
  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Adenosine and Verapamil Injection in people with Supraventricular Tachycardia (SVtach), run by Rashid Latif Medical College at 1 site in Pakistan.

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 3 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 13 Dec 2024. 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 Pakistan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Abdul Manan Shahid, FCPS (+923336302776, dr_hams79@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

achieve the normal sinus rhythm (time frame: 24 to 36 hours). 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 NCT06717685, which also lists 5 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 13 Dec 2024.

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