NCT05866731

Brief Summary

Premature atrial contractions (PACs) and premature ventricular contractions (PVCs) are observed in the majority of individuals monitored for more than a few hours. Although the clinical course of PACs and PVCs is usually benign, it has been described that high PAC or PVC frequency causes various comorbidities and worsens outcomes in different patient groups. For example, PACs can initiate episodes of atrial fibrillation, and PAC count is highly specific in predicting diagnosis of incident atrial fibrillation. Increasing PVC frequencies are an important predictor of incident heart failure. While conventional wisdom dictates that common environmental exposures determine PAC and PVC frequencies, this has not born out in rigorous studies. Whether PAC and PVC frequencies may have genetic underpinnings remains unknown. Comparisons between identical twins and fraternal twins can provide estimates of heritability. Fraternal twins are an ideal control because, like identical twins, they share a womb, have the same birthday, and their environment while growing up are as similar as between identical twins. However, while identical twins share approximately 100% of the same inherited DNA, fraternal twins share, on average, about 50%. By monitoring identical and fraternal twins with portable electrocardiograms (ECGs), we will be able to count the PACs and PVCs over a consecutive timespan to describe the familial aggregation of these complexes. This, to our knowledge, would be the first study to compare PAC and PVC frequencies in identical and same-sex fraternal twins, providing the first assessment of how genetical inheritance may influence cardiac ectopy burdens.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
156

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 22, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 10, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 19, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 18, 2025

Completed
Last Updated

March 9, 2026

Status Verified

March 1, 2026

Enrollment Period

3 years

First QC Date

May 10, 2023

Last Update Submit

March 5, 2026

Conditions

Keywords

twin

Outcome Measures

Primary Outcomes (2)

  • Frequency of premature atrial contractions (PACs)

    This will be measured using a wearable EKG monitor.

    Maximum of 2 weeks

  • Frequency of premature ventricular contractions (PVCs)

    This will be measured using a wearable EKG monitor.

    Maximum of 2 weeks

Study Arms (2)

Identical twins

60 identical twins (30 sets) will be enrolled. Participants will answer 15-20 minutes of questionnaires on demographics, lifestyle, medical history, and family history over Zoom or the phone with a study coordinator. Participants will then be mailed an iRhythm Zio XT heart rhythm monitor, or EKG, to apply and wear for a maximum of 2 weeks, as well as a DNA Genotek saliva collection kit to collect a small saliva sample. Participants will return the monitor and saliva sample to the study team, and will be reimbursed upon return. The study team is also requesting photo validation to verify twin status.

Same-sex fraternal twins

60 same-sex fraternal twins (30 sets) will be enrolled. Participants will answer 15-20 minutes of questionnaires on demographics, lifestyle, medical history, and family history over Zoom or the phone with a study coordinator. Participants will then be mailed an iRhythm Zio XT heart rhythm monitor, or EKG, to apply and wear for a maximum of 2 weeks, as well as a DNA Genotek saliva collection kit to collect a small saliva sample. Participants will return the monitor and saliva sample to the study team, and will be reimbursed upon return. The study team is also requesting photo validation to verify twin status.

Eligibility Criteria

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

Same-sex sets of twins from anywhere in the world can enroll, as all study procedures can be done remotely. Both twins must enroll to participate.

You may qualify if:

  • Identical or same-sex fraternal sets of twins
  • English-speaking

You may not qualify if:

  • Pregnancy
  • Current anti-arrhythmic medication use (including beta blockers)
  • Diagnosis of congenital heart disease
  • Diagnosis of persistent or permanent atrial fibrillation
  • Prior cardiac ablation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Saliva samples

MeSH Terms

Conditions

Atrial Premature ComplexesVentricular Premature Complexes

Condition Hierarchy (Ancestors)

Cardiac Complexes, PrematureArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Greg Marcus, MD, MAS

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 10, 2023

First Posted

May 19, 2023

Study Start

March 22, 2022

Primary Completion

March 16, 2025

Study Completion

August 18, 2025

Last Updated

March 9, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations