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

December 9, 2024 updated by: Arslan Saleem, Rashid Latif Medical College

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

210

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan
        • Recruiting
        • Punjab Institute of Cardiology
        • Contact:
        • Contact:
          • Sadaf Naeem, FCPS
          • Phone Number: +92 3414135231

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A: Conventional Valsalva
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
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)
Experimental: Group B: Modified Valsalva Maneuver
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
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)
Active Comparator: Group C: Modified Valsalva Maneuver
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
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.
Other Names:
  • Verapamil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
achieve the normal sinus rhythm
Time Frame: 24 to 36 hours

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of standard or modified vagal maneuver
Time Frame: 10 minutes
Frequency of the patients achieved NSR after standard or modified maneuver will be analyzed for efficacy.
10 minutes
Efficacy of IV verapamil and IV adenosine
Time Frame: 30 to 60 minutes
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.
30 to 60 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rashid Latif Medical College

Collaborators

Punjab Institute of Cardology
Himmel Pharmaceutical private limited, Pakistan

Investigators

  • Study Director: Hafiz Abdul Manan Shahid, FCPS, Punjab Institute of Cardiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 28, 2024

Primary Completion (Estimated)

January 27, 2025

Study Completion (Estimated)

February 3, 2025

Study Registration Dates

First Submitted

October 12, 2024

First Submitted That Met QC Criteria

December 3, 2024

First Posted (Actual)

December 5, 2024

Study Record Updates

Last Update Posted (Estimated)

December 13, 2024

Last Update Submitted That Met QC Criteria

December 9, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PIC001/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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