NCT05158751

Brief Summary

To assess potential link between unrecognized myocardial inflammation (myocarditis) and premature ventricular contractions (PVCs) associated with and without reduced Left ventricular ejection fraction (LVEF) through comprehensive diagnostic work up.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 2, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 15, 2021

Completed
4 years until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

September 4, 2025

Status Verified

October 1, 2024

Enrollment Period

2 months

First QC Date

December 2, 2021

Last Update Submit

August 27, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Identify the underlying myocarditis in patients presenting with PVCs with or without reduced LVEF

    To identify the underlying myocarditis in patients presenting with PVCs with or without reduced LVEF through laboratory testing, FDG-PET(18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose - positron emission tomography) scan, Cardiac Magnetic Resonance imaging and/or Endomyocardial biopsy.

    Retrospective Collection between dates January 2014-January 2023

Secondary Outcomes (1)

  • Ascertain whether immunosuppressive therapy (IST) affords short term and long term improvement of LVEF and clinical outcomes

    Retrospective Collection between dates January 2014-January 2023

Other Outcomes (1)

  • Evaluate whether IST + catheter ablation results in optimal clinical response

    Retrospective Collection between dates January 2014-January 2023

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Males and females with PVC and ventricular tachycardia (VT) will be enrolled if they meet the inclusion/exclusion criteria

You may qualify if:

  • Patients \> 18 years of age with mono-morphic or polymorphic PVC burden of ≥5000 in 24 hours.
  • Non-sustained VT was defined as ≥3 more consecutive beats lasting \<30 seconds

You may not qualify if:

  • History of myocardial infarction,
  • Significant flow-limiting coronary artery disease (≥50% stenosis) on invasive coronary angiography or CT angiography,
  • History of revascularization,
  • Significant symptomatic atrial arrhythmias associated with LV dysfunction,
  • Severe valvular disease,
  • Cardiomyopathy attributed to toxins such as alcohol and illicit drugs,
  • History of cardiac arrest,
  • History of channelopathies or inherited arrhythmias.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kansas City Heart Rhythm Institute

Overland Park, Kansas, 66211, United States

Location

Related Publications (32)

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MeSH Terms

Conditions

MyocarditisVentricular Premature ComplexesTachycardia, Ventricular

Condition Hierarchy (Ancestors)

CardiomyopathiesHeart DiseasesCardiovascular DiseasesCardiac Complexes, PrematureArrhythmias, CardiacCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and SymptomsTachycardia

Study Officials

  • Dhanunjaya Lakkireddy, MD

    Kansas City Heart Rhythm Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Donita Atkins

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2021

First Posted

December 15, 2021

Study Start

January 1, 2026

Primary Completion

March 1, 2026

Study Completion

May 1, 2026

Last Updated

September 4, 2025

Record last verified: 2024-10

Locations