Use of Adenosine to Determine the Electrophysiological Mechanism of Premature Ventricular Contractions

Premature Ventricular Contraction (PVC) Clinical Trial

Official title:

Use of Adenosine to Determine the Electrophysiological Mechanism of Premature Ventricular Contractions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03218137
• Other study ID #: 1609017561
• Status: Recruiting
• Phase: Phase 4
• Start date: February 13, 2017
• Est. completion date: December 31, 2025

Study information

• Verified date: September 2023
• Source: Weill Medical College of Cornell University
• Contact: James E Ip, M.D
• Phone: 212 746 2158
• Email: jei9008[@]med.cornell.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Unblinded, controlled, non-randomized, mechanistic study to determine whether physiological mechanisms underlying PVC are sensitive to adenosine. One hundred subjects undergoing clinically-indicated, standard-of-care cardiac electrophysiology study (EPS) procedure for PVCs will receive adenosine and/or verapamil to learn if their arrhythmias are inducible similarly to sustained ventricular tachycardia.

Description:

The cellular mechanism of premature ventricular contractions (PVCs) is unknown. The investigators have previously observed that 5% of patients in the investigators electrophysiology laboratory with ventricular outflow tract PVCs have inducible sustained ventricular tachycardia (VT) that behaves in a manner similar to patients who present clinically with sustained ventricular tachycardia, i.e., sensitive to adenosine and triggered activity. This suggests that outflow arrhythmias may be a continuum of a single mechanism.

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. The investigators will observe if there is any effect of reduced PVC following adenosine administration.

The investigators hypothesize that PVC will be suppressed by exogenous adenosine and/or verapamil. The information from this study will elucidate the underlying cellular mechanism of this common arrhythmia. Such knowledge could potentially lead to developing therapeutic targets. Moreover, it will have potential clinical applications for inducing outflow tract PVCs/VT in patients whose arrhythmia is suppressed at the time of their invasive electrophysiology study.

Analysis of the Holter recording of premature ventricular contractions:

Analysis of the PVC coupling intervals can be helpful for delineating the mechanism of PVCs. Holter monitors are being obtained on these patients prior to ablation as part of standard of care. Holters monitors, if performed at our institution, will be analyzed in detail in a retrospective fashion. Holter reports from 1/1/2015 - 5/15/2019 will be reviewed.

Specifically, evaluating the time intervals between PVCs and normal heart beats may elucidate potential arrhythmia mechanism as triggered activity or modulated parasystole. Since a subject has approximately 100,000 heart beats in 24 hours, the Holter data have to be read by a converter file and outputted to an Excel file for our further analysis. The investigators do not have access to a converter file and it is not commercially available. The investigators will send the de-identified data to Dr. Mortara at UCSF. The investigators will then analyze the timing intervals among PVCs and normal heart beats. It should be noted that these Holters are obtained as part of a patient's normal evaluation and are not obtained for the purposes of this study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Diagnosis of premature ventricular contractions (PVCs)

• Scheduled to undergo an electrophysiology study with the intention of performing cardiac ablation for the treatment of PVCs

• Male or female between the ages of 18 and 70 years

• Capable of giving informed consent

Exclusion Criteria:

• Any structural heart disease

• Coronary artery disease (= 70% stenosis)

• Current treatment with anti-arrhythmic drugs

• Pregnant

• Asthma (if administering adenosine)

Related Conditions & MeSH terms

• Premature Birth
• Premature Ventricular Contraction (PVC)
• Ventricular Premature Complexes

Intervention

Drug:
• Adenosine
Adenosine: 0.84 mg/kg (140 mcg/kg/minute IV for 6 minutes) Verapamil 0.15 mg/kg

Locations

Country	Name	City	State
United States	Weill Cornell Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effects of Adenosine on premature ventricular contractions (PVCs) as measured by EKG;	The metrics that will be collected will be: Baseline frequency of premature ventricular contractions (PVCs); Frequency of premature ventricular contractions (PVCs) during adenosine administration	baseline
Primary	Effects of verapamil on premature ventricular contractions (PVCs) as measured by EKGs.	The metrics that will be collected will be: Baseline frequency of premature ventricular contractions (PVCs); Frequency of premature ventricular contractions (PVCs) during verapamil administration	baseline