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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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%
0%
Study treatment Arm
Study Arm

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

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
1,055 Previous Clinical Trials
1,316,195 Total Patients Enrolled
James E Ip, M.DPrincipal InvestigatorWeill Medical College of Cornell University

Media Library

Adenosine/ Verapamil Arm Clinical Trial Eligibility Overview. Trial Name: NCT03218137 — Phase 4
Premature Ventricular Contractions Research Study Groups: Adenosine/ Verapamil Arm
Premature Ventricular Contractions Clinical Trial 2023: Adenosine/ Verapamil Arm Highlights & Side Effects. Trial Name: NCT03218137 — Phase 4
Adenosine/ Verapamil Arm 2023 Treatment Timeline for Medical Study. Trial Name: NCT03218137 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this clinical trial still recruiting participants?

"Affirmative. Clinicaltrials.gov reveals that this research endeavor, which commenced on February 13th 2017, is actively recruiting participants. Approximately 100 people must be enrolled at a single medical site."

Answered by AI

How many participants are taking part in this clinical trial?

"Affirmative, the information hosted on clinicaltrials.gov suggests that this research is actively seeking suitable candidates. This investigation was launched on February 13th 2017 and recently updated in October 17th 2022; 100 individuals are required to be recruited from one medical facility."

Answered by AI

Is the treatment being proposed secure for patients?

"We assign this therapy a safety score of 3, as there is ample evidence that it has been approved in Phase 4 clinical trials."

Answered by AI

In what cases is this therapy typically implemented?

"This novel intervention offers potential relief for individuals suffering from tachycardia, ventricular issues, vasospastic angina, and difficulty exercising."

Answered by AI

Is this research open to elderly participants?

"The requirements for participation in this clinical trial necessitate that applicants must be between 18 and 70 years old. For those younger than eighteen, there are 186 studies available; similarly, 90 research initiatives exist for seniors above the age of 65."

Answered by AI

Is there an eligibility criterion for participating in this clinical investigation?

"In order to be considered for the trial, potential patients must have ventricular premature complexes and lie between 18 to 70 years of age. This medical study is set to enroll 100 individuals."

Answered by AI
~14 spots leftby Jun 2025