Supraventricular TachycardiaPhase 4NCT00413712
Effectiveness of Calcium Channel Blockers and Adenosine in the Emergency Management of SVT
A Phase 4 study testing Calcium Channel Blocker & Adenosine in people with Supraventricular Tachycardia, run by Singapore General Hospital at 1 site in Singapore.
Trial summary
The purpose of this study is to determine the efficacy and effectiveness of calcium channel blockers and adenosine in the treatment of Supraventricular Tachycardia. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Supraventricular Tachycardia
- What is being tested?
- Calcium Channel Blocker & Adenosine
- How many people
- 206 participants
- Where
- 1 siteSingapore
- Study dates
- Jan 1997to Mar 2001
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- More than 10 years old
- Electrocardiographic diagnosis of SVT
- SVT not converted by the vagal manoeuvres
Who cannot join
- Signs of impaired cerebral perfusion
- Signs of pulmonary oedema
- Subsequent diagnosis of other types of arrythmias rather than SVT
- pregnancy by history
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparism Between Efficacy and Effectiveness Between Slow Infusion of Calcium Channel Blockers and Intravenous Bolus Adenosine in the Management of Supraventricular Tachycardia in the Emergency Department.
The purpose of this study is to determine the efficacy and effectiveness of calcium channel blockers and adenosine in the treatment of Supraventricular Tachycardia.
Read the detailed description
Paroxysmal Supraventricular Tachycardia (SVT) is a common cardiac emergency encountered in the Emergency Department. Both Calcium Channel Blockers (CCB) and Adenosine have been using in the Management of SVT.
Objective
This study compared the efficacy and effectiveness between slow Infusion of Calcium Channel Blockers (either Verapamil or Diltiazem) and bolus intravenous Adenosine in termination of SVT.
Methodology
This was a prospective, randomised, controlled clinical trial comparing the efficacy and effects of intravenous adenosine with slow infusion of calcium channel blockers (verapamil or diltiazem) in patients presenting with SVT to an Emergency Department. The study was approved by the hospital's Ethics Committee.
Patients of at least 10 years of age, who presented to the Emergency Department of the Singapore General Hospital with regular narrow complex tachycardia and an electrocardiographic(ECG) diagnosis of SVT that was not converted by vagal manoeuvres (Valsava manoeuvre or carotid sinus massage or both) and who were in SVT at the time of doctor attendance were included in the study.
The exclusion criteria were as follows:
- Patients with signs of impaired cerebral perfusion (e.g. altered mental state) or acute pulmonary oedema
- Patients with a subsequent diagnosis of arrhythmias other than SVT (i.e. sinus tachycardia, atrial flutter, atrial fibrillation or idiopathic ventricular tachycardia) were excluded from the analysis if they were initially enrolled
- Pregnancy by history (urine pregnancy testing was not used to actively exclude the condition in any of the female patients entered into the study).
Having selected the patients according to the criteria, they were randomly assigned into two groups: one to receive calcium channel blockers and the other, Adenosine. Within the former group, some were assigned randomly to receive Diltiazem and some to Verapamil.
Diltiazem was given at the dose of 2.5mg per minute (4ml per minute of a concentration of 0.625 mg/ml) up to a maximum of 50 mg. The dose of Verapamil was 1mg per minute (4ml per minute of a concentration of 0.25mg/ml) up to a maximum of 20mg. Both were given as a slow intravenous infusion using a Terumo infusion pump.
During intravenous infusion, the patient's vital signs, viz. heart rate and systolic and diastolic blood pressures, were monitored at two-minute intervals up to completion of infusion or conversion from SVT, whichever was the earlier. At the time of conversion to sinus rhythm, the infusion was stopped and the amount of drug infused was noted and recorded.
Regarding the Adenosine group, all the patients were administered Adenosine as a rapid bolus within 2 sec through an 18G IV cannula at an antecubital vein, followed by 10 ml saline flush and elevation of the limb. Initially 6ml bolus was given rapidly, and if there was no conversion of the SVT within 2 min, another 12 mg bolus was administered.
If SVT was not converted at the end of any of calcium channel blocker infusion, those patients were then given intravenous Adenosine as described above. Similarly, those patients who remained in SVT after first two initial boluses of Adenosine were again randomized to receive either Verapamil or Diltiazem.
This allowed four orders of treatment as follows:
- Verapamil infusion followed by Adenosine
- Diltiazem infusion followed by Adenosine
- Adenosine followed by Verapamil infusion
- Adenosine followed by Diltiazem infusion
If the tachycardia was not converted at the end of the study protocol, patients were managed either with synchronised electrical cardioversion if haemodynamically unstable or with further pharmacotherapy at the discretion of the treating physician if vital signs were stable.
Following the successful conversion, patients' vital signs were closely monitored at 1 min (immediate post-conversion), 5,10, 15 min and finally 30 min of post-conversion. If they remained stable, they were shifted to observation ward with continuous telemetric monitoring. They were eventually discharged if there were no recurrence during the period of observation and arranged a follow-up appointment at Arrhythmia Clinic one week later. Patients with the recurrence of SVT during the two-hour observation period were managed at the discretion of the treating physician.
Study end points were as follows:
- Conversion to sinus rhythm
- Withdrawal because of major adverse effects
- Completion of trial protocol without termination of tachycardia
Data on the final analysis was obtained from follow-up records of Cardiology department as well. The cost of medication used for each patient was also computed to understand the cost aspects of different regimens.
- Conditions
- Supraventricular Tachycardia
- Being tested
- Calcium Channel Blocker & Adenosine
- Keywords
- Supraventricular Tachycardia, Calcium Channel Blockers, Verapamil, Diltiazem, Adenosine
- Medical subject headings
- Tachycardia, Supraventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium Channel Blocker & AdenosineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Conversion to the sinus rhythm.
Secondary outcomes (2)
Recurrence of SVT
Stability of vital signs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2006 (estimated)
- Study startJan 1997
- Study completionMar 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Supraventricular TachycardiaStudies of the same condition, open and under way.
- More trials run by Singapore General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 206 participants
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lim S Han, MBBS,FRCS, Principal investigator, Department of Emergency Medicine, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00413712
- Sponsor's protocol ID
- IRB18/1997
- Status last verified
- Feb 2017
- First submitted
- 19 Dec 2006
- Last updated
- 10 Feb 2017
- Results posted
- No
Publications
Lim SH, Anantharaman V, Teo WS. Slow-infusion of calcium channel blockers in the emergency management of supraventricular tachycardia. Resuscitation. 2002 Feb;52(2):167-74. doi: 10.1016/s0300-9572(01)00459-2.
PubMed 11841884Brady WJ Jr, DeBehnke DJ, Wickman LL, Lindbeck G. Treatment of out-of-hospital supraventricular tachycardia: adenosine vs verapamil. Acad Emerg Med. 1996 Jun;3(6):574-85. doi: 10.1111/j.1553-2712.1996.tb03467.x.
PubMed 8727628Madsen CD, Pointer JE, Lynch TG. A comparison of adenosine and verapamil for the treatment of supraventricular tachycardia in the prehospital setting. Ann Emerg Med. 1995 May;25(5):649-55. doi: 10.1016/s0196-0644(95)70179-6.
PubMed 7741343Sethi KK, Singh B, Kalra GS, Arora R, Khalilullah M. Comparative clinical and electrophysiologic effects of adenosine and verapamil on termination of paroxysmal supraventricular tachycardia. Indian Heart J. 1994 May-Jun;46(3):141-4.
PubMed 7821934Viskin S, Belhassen B. Acute management of paroxysmal atrioventricular junctional reentrant supraventricular tachycardia: pharmacologic strategies. Am Heart J. 1990 Jul;120(1):180-8. doi: 10.1016/0002-8703(90)90176-x.
PubMed 2193494Camm AJ, Garratt CJ. Adenosine and supraventricular tachycardia. N Engl J Med. 1991 Dec 5;325(23):1621-9. doi: 10.1056/NEJM199112053252306. No abstract available.
PubMed 1944450Cairns CB, Niemann JT. Intravenous adenosine in the emergency department management of paroxysmal supraventricular tachycardia. Ann Emerg Med. 1991 Jul;20(7):717-21. doi: 10.1016/s0196-0644(05)80829-7.
PubMed 2064090DiMarco JP, Miles W, Akhtar M, Milstein S, Sharma AD, Platia E, McGovern B, Scheinman MM, Govier WC. Adenosine for paroxysmal supraventricular tachycardia: dose ranging and comparison with verapamil. Assessment in placebo-controlled, multicenter trials. The Adenosine for PSVT Study Group. Ann Intern Med. 1990 Jul 15;113(2):104-10. doi: 10.7326/0003-4819-113-2-104.
PubMed 2193560Belardinelli L, Linden J, Berne RM. The cardiac effects of adenosine. Prog Cardiovasc Dis. 1989 Jul-Aug;32(1):73-97. doi: 10.1016/0033-0620(89)90015-7. No abstract available.
PubMed 2664879Garratt C, Linker N, Griffith M, Ward D, Camm AJ. Comparison of adenosine and verapamil for termination of paroxysmal junctional tachycardia. Am J Cardiol. 1989 Dec 1;64(19):1310-6. doi: 10.1016/0002-9149(89)90573-0.
PubMed 2589197Belhassen B, Glick A, Laniado S. Comparative clinical and electrophysiologic effects of adenosine triphosphate and verapamil on paroxysmal reciprocating junctional tachycardia. Circulation. 1988 Apr;77(4):795-805. doi: 10.1161/01.cir.77.4.795.
PubMed 3349581Klein HO, Ninio R, Oren V, Lang R, Sareli P, DiSegni E, David D, Guerrero J, Kaplinsky E. The acute hemodynamic effects of intravenous verapamil in coronary artery disease. Assessment by equilibrium-gated radionuclide ventriculography. Circulation. 1983 Jan;67(1):101-10. doi: 10.1161/01.cir.67.1.101.
PubMed 6291805Betriu A, Chaitman BR, Bourassa MG, Brevers G, Scholl JM, Bruneau P, Gagne P, Chabot M. Beneficial effect of intravenous diltiazem in the acute management of paroxysmal supraventricular tachyarrhythmias. Circulation. 1983 Jan;67(1):88-94. doi: 10.1161/01.cir.67.1.88.
PubMed 6847809Mitchell LB, Schroeder JS, Mason JW. Comparative clinical electrophysiologic effects of diltiazem, verapamil and nifedipine: a review. Am J Cardiol. 1982 Feb 18;49(3):629-35. doi: 10.1016/s0002-9149(82)80022-2.
PubMed 6277182Singh BN, Hecht HS, Nademanee K, Chew CY. Electrophysiologic and hemodynamic effects of slow-channel blocking drugs. Prog Cardiovasc Dis. 1982 Sep-Oct;25(2):103-32. doi: 10.1016/0033-0620(82)90023-8. No abstract available.
PubMed 7051136
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparism Between Efficacy and Effectiveness Between Slow Infusion of Calcium Channel Blockers and Intravenous Bolus Adenosine in the Management of Supraventricular Tachycardia in the Emergency Department.
- ClinicalTrials.gov ID
- NCT00413712
- Acronym / sponsor ID
- IRB18/1997
- Conditions
- Supraventricular Tachycardia
- Keywords
- Supraventricular Tachycardia, Calcium Channel Blockers, Verapamil, Diltiazem, Adenosine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Study start
- Jan 1997
- Study completion
- Mar 2001
- First posted
- 20 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the efficacy and effectiveness of calcium channel blockers and adenosine in the treatment of Supraventricular Tachycardia.
Detailed description
Paroxysmal Supraventricular Tachycardia (SVT) is a common cardiac emergency encountered in the Emergency Department. Both Calcium Channel Blockers (CCB) and Adenosine have been using in the Management of SVT.
Objective
This study compared the efficacy and effectiveness between slow Infusion of Calcium Channel Blockers (either Verapamil or Diltiazem) and bolus intravenous Adenosine in termination of SVT.
Methodology
This was a prospective, randomised, controlled clinical trial comparing the efficacy and effects of intravenous adenosine with slow infusion of calcium channel blockers (verapamil or diltiazem) in patients presenting with SVT to an Emergency Department. The study was approved by the hospital's Ethics Committee.
Patients of at least 10 years of age, who presented to the Emergency Department of the Singapore General Hospital with regular narrow complex tachycardia and an electrocardiographic(ECG) diagnosis of SVT that was not converted by vagal manoeuvres (Valsava manoeuvre or carotid sinus massage or both) and who were in SVT at the time of doctor attendance were included in the study.
The exclusion criteria were as follows:
- Patients with signs of impaired cerebral perfusion (e.g. altered mental state) or acute pulmonary oedema
- Patients with a subsequent diagnosis of arrhythmias other than SVT (i.e. sinus tachycardia, atrial flutter, atrial fibrillation or idiopathic ventricular tachycardia) were excluded from the analysis if they were initially enrolled
- Pregnancy by history (urine pregnancy testing was not used to actively exclude the condition in any of the female patients entered into the study).
Having selected the patients according to the criteria, they were randomly assigned into two groups: one to receive calcium channel blockers and the other, Adenosine. Within the former group, some were assigned randomly to receive Diltiazem and some to Verapamil.
Diltiazem was given at the dose of 2.5mg per minute (4ml per minute of a concentration of 0.625 mg/ml) up to a maximum of 50 mg. The dose of Verapamil was 1mg per minute (4ml per minute of a concentration of 0.25mg/ml) up to a maximum of 20mg. Both were given as a slow intravenous infusion using a Terumo infusion pump.
During intravenous infusion, the patient's vital signs, viz. heart rate and systolic and diastolic blood pressures, were monitored at two-minute intervals up to completion of infusion or conversion from SVT, whichever was the earlier. At the time of conversion to sinus rhythm, the infusion was stopped and the amount of drug infused was noted and recorded.
Regarding the Adenosine group, all the patients were administered Adenosine as a rapid bolus within 2 sec through an 18G IV cannula at an antecubital vein, followed by 10 ml saline flush and elevation of the limb. Initially 6ml bolus was given rapidly, and if there was no conversion of the SVT within 2 min, another 12 mg bolus was administered.
If SVT was not converted at the end of any of calcium channel blocker infusion, those patients were then given intravenous Adenosine as described above. Similarly, those patients who remained in SVT after first two initial boluses of Adenosine were again randomized to receive either Verapamil or Diltiazem.
This allowed four orders of treatment as follows:
- Verapamil infusion followed by Adenosine
- Diltiazem infusion followed by Adenosine
- Adenosine followed by Verapamil infusion
- Adenosine followed by Diltiazem infusion
If the tachycardia was not converted at the end of the study protocol, patients were managed either with synchronised electrical cardioversion if haemodynamically unstable or with further pharmacotherapy at the discretion of the treating physician if vital signs were stable.
Following the successful conversion, patients' vital signs were closely monitored at 1 min (immediate post-conversion), 5,10, 15 min and finally 30 min of post-conversion. If they remained stable, they were shifted to observation ward with continuous telemetric monitoring. They were eventually discharged if there were no recurrence during the period of observation and arranged a follow-up appointment at Arrhythmia Clinic one week later. Patients with the recurrence of SVT during the two-hour observation period were managed at the discretion of the treating physician.
Study end points were as follows:
- Conversion to sinus rhythm
- Withdrawal because of major adverse effects
- Completion of trial protocol without termination of tachycardia
Data on the final analysis was obtained from follow-up records of Cardiology department as well. The cost of medication used for each patient was also computed to understand the cost aspects of different regimens.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- More than 10 years old
- Electrocardiographic diagnosis of SVT
- SVT not converted by the vagal manoeuvres
Key exclusion criteria (4 listed)
- Signs of impaired cerebral perfusion
- Signs of pulmonary oedema
- Subsequent diagnosis of other types of arrythmias rather than SVT
- pregnancy by history
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcium Channel Blocker & Adenosine | Drug | – |
Primary outcome
Conversion to the sinus rhythm.
2 secondary outcomes
Recurrence of SVT
Stability of vital signs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2017.
- Background: PubMed 11841884Lim SH, Anantharaman V, Teo WS. Slow-infusion of calcium channel blockers in the emergency management of supraventricular tachycardia. Resuscitation. 2002 Feb;52(2):167-74. doi: 10.1016/s0300-9572(01)00459-2.
- Background: PubMed 8727628Brady WJ Jr, DeBehnke DJ, Wickman LL, Lindbeck G. Treatment of out-of-hospital supraventricular tachycardia: adenosine vs verapamil. Acad Emerg Med. 1996 Jun;3(6):574-85. doi: 10.1111/j.1553-2712.1996.tb03467.x.
- Background: PubMed 7741343Madsen CD, Pointer JE, Lynch TG. A comparison of adenosine and verapamil for the treatment of supraventricular tachycardia in the prehospital setting. Ann Emerg Med. 1995 May;25(5):649-55. doi: 10.1016/s0196-0644(95)70179-6.
- Background: PubMed 7821934Sethi KK, Singh B, Kalra GS, Arora R, Khalilullah M. Comparative clinical and electrophysiologic effects of adenosine and verapamil on termination of paroxysmal supraventricular tachycardia. Indian Heart J. 1994 May-Jun;46(3):141-4.
- Background: PubMed 2193494Viskin S, Belhassen B. Acute management of paroxysmal atrioventricular junctional reentrant supraventricular tachycardia: pharmacologic strategies. Am Heart J. 1990 Jul;120(1):180-8. doi: 10.1016/0002-8703(90)90176-x.
- Background: PubMed 1944450Camm AJ, Garratt CJ. Adenosine and supraventricular tachycardia. N Engl J Med. 1991 Dec 5;325(23):1621-9. doi: 10.1056/NEJM199112053252306. No abstract available.
- Background: PubMed 2064090Cairns CB, Niemann JT. Intravenous adenosine in the emergency department management of paroxysmal supraventricular tachycardia. Ann Emerg Med. 1991 Jul;20(7):717-21. doi: 10.1016/s0196-0644(05)80829-7.
- Background: PubMed 2193560DiMarco JP, Miles W, Akhtar M, Milstein S, Sharma AD, Platia E, McGovern B, Scheinman MM, Govier WC. Adenosine for paroxysmal supraventricular tachycardia: dose ranging and comparison with verapamil. Assessment in placebo-controlled, multicenter trials. The Adenosine for PSVT Study Group. Ann Intern Med. 1990 Jul 15;113(2):104-10. doi: 10.7326/0003-4819-113-2-104.
- Background: PubMed 2664879Belardinelli L, Linden J, Berne RM. The cardiac effects of adenosine. Prog Cardiovasc Dis. 1989 Jul-Aug;32(1):73-97. doi: 10.1016/0033-0620(89)90015-7. No abstract available.
- Background: PubMed 2589197Garratt C, Linker N, Griffith M, Ward D, Camm AJ. Comparison of adenosine and verapamil for termination of paroxysmal junctional tachycardia. Am J Cardiol. 1989 Dec 1;64(19):1310-6. doi: 10.1016/0002-9149(89)90573-0.
- Background: PubMed 3349581Belhassen B, Glick A, Laniado S. Comparative clinical and electrophysiologic effects of adenosine triphosphate and verapamil on paroxysmal reciprocating junctional tachycardia. Circulation. 1988 Apr;77(4):795-805. doi: 10.1161/01.cir.77.4.795.
- Background: PubMed 6291805Klein HO, Ninio R, Oren V, Lang R, Sareli P, DiSegni E, David D, Guerrero J, Kaplinsky E. The acute hemodynamic effects of intravenous verapamil in coronary artery disease. Assessment by equilibrium-gated radionuclide ventriculography. Circulation. 1983 Jan;67(1):101-10. doi: 10.1161/01.cir.67.1.101.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lim S Han, MBBS,FRCS principal investigator
Department of Emergency Medicine, Singapore General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Calcium Channel Blocker & Adenosine in people with Supraventricular Tachycardia, run by Singapore General Hospital at 1 site in Singapore.
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 4 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: finished, as of the sponsor's last update on 10 Feb 2017. 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 Singapore. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conversion to the sinus rhythm.. 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 NCT00413712, which also lists 23 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 10 Feb 2017.