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NCT Number: NCT06717685

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

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.

Other names: Verapamil

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Abdul Manan Shahid, FCPS

CONTACT

[email protected]

+923336302776

Arslan Saleem Chughtai, M.Phil.

CONTACT

[email protected]

+923334585339

Sponsors and collaborators

Lead sponsor

Rashid Latif Medical College

Other

Collaborators

  • Himmel Pharmaceutical private limited, Pakistan
  • Punjab Institute of Cardology

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 5, 2024
Registry last updated
Dec 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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