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Adenosine for Premature Ventricular Contractions

Phase 4

Recruiting

Led By James E Ip, M.D

Research Sponsored by Weill Medical College of Cornell University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female between the ages of 18 and 70 years

Capable of giving informed consent

Must not have

Coronary artery disease (≥ 70% stenosis)

Current treatment with anti-arrhythmic drugs

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

No Placebo-Only Group

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial will study whether a drug called adenosine can help people with a heart condition called PVC. One hundred people will be given adenosine and/or verapamil to see if their arrhythmias can be controlled better.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Adenosine may cause chest pain or pressure, a sense of 'impending doom', shortness of breath, lightheadedness, headache, nausea; these effects are generally short-lived as adenosine acts very briefly.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 70 years old.

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I understand the study and can agree to participate.

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

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I have been diagnosed with irregular heartbeats.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I am currently taking medication for heart rhythm problems.

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I have a heart condition involving the structure of my heart.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Effects of Adenosine on premature ventricular contractions (PVCs) as measured by EKG;

Effects of verapamil on premature ventricular contractions (PVCs) as measured by EKGs.

Side effects data

From 2011 Phase 3 trial • 22 Patients • NCT03231371

18%

Transient Atrial Ventricular block, self-resolved without intervention

100%

80%

60%

40%

20%

Study treatment Arm

Study Arm

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Adenosine/ Verapamil ArmExperimental Treatment1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Verapamil

FDA approved

0 / 7Eligibility criteria met