Adenosine for Premature Ventricular Contractions

Overseen By James Ip

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Weill Medical College of Cornell University

Must not be taking: Anti-arrhythmic drugs

Disqualifiers: Structural heart disease, Coronary artery disease, Asthma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how adenosine affects individuals with premature ventricular contractions (PVCs), which are extra heartbeats that may cause the heart to flutter or skip. Researchers aim to determine if adenosine can help manage these irregular heartbeats. Participants will receive adenosine and possibly verapamil, a medication that slows the heart rate, during a heart procedure. The trial seeks individuals with PVCs who are planning to undergo an electrophysiology study, a specific heart test and treatment. As a Phase 4 trial, this research involves an FDA-approved treatment and aims to understand its benefits for more patients with PVCs.

Will I have to stop taking my current medications?

The trial requires that participants are not currently being treated with anti-arrhythmic drugs, so you would need to stop taking those medications to join.

What is the safety track record for adenosine and verapamil?

Research shows that adenosine can help manage certain heart rhythm problems. Earlier studies found that adenosine can stop some types of irregular heartbeats. However, like any medicine, it can have side effects. Some reports indicate that adenosine might cause irregular heartbeats, such as early beats in the heart's upper chamber, or even increase the heart rate in some cases.

Adenosine is usually well-tolerated, and its side effects often last only a few seconds. However, it might cause breathing issues, such as tightening of the airways, in some people.

Since this trial is a Phase 4 study, adenosine has already been approved for other uses. This means there is existing evidence of its safety in humans, although individual reactions can vary. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatments for premature ventricular contractions (PVCs), which often include beta-blockers or calcium channel blockers, adenosine offers a unique approach by directly targeting the heart's electrical activity. Adenosine is known to terminate ventricular arrhythmias caused by triggered activity, offering a potentially faster and more precise method of intervention. Researchers are particularly excited about adenosine because it acts quickly and can be administered during an electrophysiology study to immediately assess its effectiveness in real-time. This rapid action and targeted mechanism make adenosine a promising option for those whose PVCs are resistant to other treatments.

What is the effectiveness track record for adenosine in treating premature ventricular contractions?

Research has shown that adenosine effectively stops certain heart rhythm problems, particularly narrow QRS complex tachycardia. It can sometimes cause extra heartbeats, known as premature ventricular contractions (PVCs). Despite this, adenosine has proven helpful for irregular heartbeats related to specific triggers. In this trial, participants will receive a combination of adenosine and verapamil to study its effects on PVCs. Verapamil, a medication that initially slows the heart, will be administered before adenosine to assess how this combination affects PVCs. ^{6 7 8 9 10}

Who Is on the Research Team?

James E Ip, M.D

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

This trial is for adults aged 18-70 with premature ventricular contractions (PVCs) who are scheduled for an electrophysiology study and potential cardiac ablation. Participants must be able to consent and not on anti-arrhythmic drugs, pregnant, have structural heart disease, significant coronary artery blockage, or asthma if adenosine is used.

Inclusion Criteria

I understand the study and can agree to participate.

I am scheduled for a procedure to correct heart rhythm issues caused by PVCs.

I have been diagnosed with irregular heartbeats.

Exclusion Criteria

You have asthma and are going to be given adenosine.

I have severe narrowing (70% or more) in my heart's arteries.

Pregnant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a cardiac electrophysiology study (EPS) procedure, receive Verapamil to slow the heart, and then receive Adenosine to study its effects on PVCs.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including analysis of Holter monitor data.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Adenosine

Trial Overview The study tests whether the physiological mechanisms causing PVCs respond to adenosine. It's an unblinded, controlled study involving 100 subjects already undergoing standard cardiac EPS procedures for PVCs. They will receive adenosine and/or verapamil to see if their arrhythmias can be induced like sustained ventricular tachycardia.

How Is the Trial Designed?

Group I: Adenosine/ Verapamil Arm Experimental Treatment 1 Intervention

Adenosine: 0.84 mg/kg IV (140 mcg/kg/minute IV for 6 minutes) Verapamil: 0.15 mg/kg IV Adenosine is known to terminate ventricular arrhythmias that are due to triggered activity (ref Lerman). To study the effects of adenosine on PVC, the investigators will administer Verapamil to slow down the heart initially and adenosine after catheters are introduced to patients who are being treated for symptomatic PVC and have consented to treatment with an invasive electrophysiology study and catheter ablation.

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Published Research Related to This Trial

Regadenoson is an effective pharmacologic stress agent for myocardial perfusion imaging, showing noninferior agreement in detecting reversible perfusion defects compared to adenosine in two phase III trials involving patients with coronary artery disease.

It is generally well tolerated, with most side effects resolving within about 15 minutes, and no unexpected ECG changes were observed, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regadenoson. Garnock-Jones, KP., Curran, MP.[2022]

Adenosine is an approved treatment for paroxysmal supraventricular tachycardia, known for its very short half-life of 10 seconds and common but transient side effects like facial flushing and dyspnea.

This report highlights a unique case of a prolonged anaphylactoid reaction in an elderly woman after adenosine administration, marking the first documented instance of such a reaction, which required additional pharmacological intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anaphylactoid reaction to adenosine. Fata, JG., Roth, RN., Carpenter, L.[2019]

Adenosine is effective in terminating supraventricular tachycardias by slowing conduction through the AV node, making it a valuable tool in emergency settings for managing arrhythmias.

While adenosine is generally considered safe due to its short half-life and minimal serious side effects, this case highlights a potential risk of non-sustained polymorphic ventricular tachycardia following its administration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adenosine-induced non-sustained polymorphic ventricular tachycardia. Romer, M., Candinas, R.[2019]

Adenoscan injection (adenosine) was found to be safe for use in patients unable to exercise, with an overall adverse drug reaction (ADR) rate of 16.0%, most of which were mild and resolved quickly without treatment.

The efficacy of Adenoscan for myocardial perfusion scintigraphy was high, with a success rate of 97.9% in 2,150 patients, making it a valuable tool for detecting ischemic heart disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The drug use results survey of Adenoscan injection 60 mg]. Hikita, A., Okita, Y., Kawai, M., et al.[2017]

Adenosine (Adenocard) is an injectable medication specifically used for the acute treatment of paroxysmal supraventricular tachycardia (PSVT), including cases linked to Wolff-Parkinson-White syndrome.

Despite its effectiveness in treating PSVT, many physicians remain unfamiliar with how adenosine works, its indications, and potential side effects, highlighting a need for increased awareness and education about this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical use of adenosine. Geraets, D., Kienzle, M.[2013]

Regadenoson, a selective A(2A) adenosine receptor agonist, shows promise as a pharmacologic stress agent for myocardial perfusion imaging, producing rapid and sustained hyperemia, which is beneficial for imaging procedures.

Unlike traditional vasodilators like adenosine and dipyridamole, which activate multiple adenosine receptor subtypes leading to undesirable effects, regadenoson selectively targets the A(2A) receptor, potentially reducing side effects and improving patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The future of pharmacologic stress: selective A2A adenosine receptor agonists. Cerqueira, MD.[2015]

Regadenoson and binodenoson, two selective adenosine A2A receptor agonists, show promise as safer alternatives to traditional pharmacologic stress agents like dipyridamole and adenosine, with ongoing Phase III studies evaluating their efficacy.

Both regadenoson and binodenoson demonstrated similar effectiveness to adenosine in detecting ischemia during single-photon emission CT imaging, while exhibiting a lower incidence of serious side effects such as atrioventricular block or bronchospasm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in pharmacologic agents in imaging: new A2A receptor agonists. Cerqueira, MD.[2019]

Adenosine effectively terminated paroxysmal supraventricular tachycardia (PSVT) in 36.4% of patients and helped diagnose unclear PSVT types in 47.7% of cases, demonstrating its utility in managing arrhythmias.

While subjective complaints were common after administration (80.6% of patients), they were short-lived and not clinically significant, indicating that adenosine is safe with no relevant complications observed in the study of 62 patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effectiveness and safety of adenosine in the therapy and diagnosis of arrhythmias]. Dúbrava, J., Jurkovicová, O.[2022]

Regadenoson, a selective A2A receptor agonist used for myocardial perfusion imaging, has been shown to have equivalent diagnostic accuracy for coronary artery disease compared to adenosine, with fewer serious side effects in multicenter trials.

However, recent cases indicate that regadenoson may carry a higher risk of life-threatening bradycardia, including asystole, than previously recognized, emphasizing the need for caution and monitoring in patients receiving this medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Asystole following regadenoson infusion in stable outpatients. Rosenblatt, J., Mooney, D., Dunn, T., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6932601/

Adenosine‐Induced Ventricular Arrhythmias in Patients ... Conclusions: Adenosine is a quite safe and effective drug for the termination of narrow QRS complex tachycardia but it often induces nonsustained VT or PVC ...

2. trialx.com trialx.com/clinical-trials/listings/270859/use-of-adenosine-to-determine-the-electrophysiological-mechanism-of-premature-ventricular-contractions/

Use of Adenosine to Determine the Electrophysiological ... To study the effects of adenosine on PVC, the investigators will administer Verapamil to slow down the heart initially and adenosine after ...

3. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK519049/

Adenosine - StatPearls - NCBI Bookshelf - NIH Adenosine is used for its antiarrhythmic properties in supraventricular tachycardia (SVT) and can function as a diagnostic tool, depending on the type of SVT.

4. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.119.042434

Evaluation and Management of Premature Ventricular ... In 1995, a randomized trial demonstrated that amiodarone suppressed PVCs and resulted in a significant increase in LVEF among patients who had ...

5. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/540715

Use of Adenosine to Determine the Electrophysiological ... Outcome measure. Effects of Adenosine on premature ventricular contractions (PVCs) as measured by EKG; · Measure description. The metrics that will be collected ...

6. rxlist.com rxlist.com/adenocard-drug.htm

Adenocard I.V. (Adenosine): Side Effects, Uses, Dosage, ... They generally last only a few seconds without intervention, and may take the form of premature ventricular contractions, atrial premature contractions, atrial ...

7. medsafe.govt.nz medsafe.govt.nz/profs/datasheet/a/adenocorinj.pdf

data sheet 1 adenocor 6 mg/2 ml solution for intravenous ... Adenosine may precipitate or aggravate bronchospasm. Paediatric Use. ADENOCOR may trigger atrial arrhythmias and thus might lead to ventricular acceleration in.

8. pubchem.ncbi.nlm.nih.gov pubchem.ncbi.nlm.nih.gov/compound/Adenosine

Adenosine | C10H13N5O4 | CID 60961 - PubChem - NIH More severe symptoms are cardiac-related and include the development of cardiac arrhythmia, including premature atrial contractions and premature ventricular ...

9. nursing.unboundmedicine.com nursing.unboundmedicine.com/nursingcentral/view/Davis-Drug-Guide/51015/all/adenosine?q=pressure

Adenosine (Adenocard, Adenoscan) | Davis's Drug Guide Find information on Adenosine (Adenocard, Adenoscan) in Davis's Drug Guide including dosage, side effects, interactions, nursing implications, mechanism of ...

10. clinicaltrials.gov clinicaltrials.gov/study/NCT03218137

Study Details | NCT03218137 | Use of Adenosine to ... Adenosine is known to terminate ventricular arrhythmias that are due to triggered activity (ref Lerman). To study the effects of adenosine on PVC, the ...