The Heart Rhythm Twins Study

Premature Ventricular Contraction Clinical Trial

Official title:

The Heart Rhythm Twins Study -- A Pilot Study in Identical and Fraternal Twins

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05866731
• Other study ID #: 21-35126
• Status: Recruiting
• Start date: March 22, 2022
• Est. completion date: January 1, 2025

Study information

• Verified date: May 2024
• Source: University of California, San Francisco
• Contact: Grace Wall
• Phone: 415-562-5906
• Email: grace.wall[@]ucsf.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Identical or same-sex fraternal sets of twins

• English-speaking

Exclusion Criteria:

• Pregnancy

• Current anti-arrhythmic medication use (including beta blockers)

• Diagnosis of congenital heart disease

• Diagnosis of persistent or permanent atrial fibrillation

• Prior cardiac ablation

Related Conditions & MeSH terms

• Atrial Premature Complexes
• Premature Atrial Complex
• Premature Birth
• Premature Ventricular Contraction
• Ventricular Premature Complexes

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of premature atrial contractions (PACs)	This will be measured using a wearable EKG monitor.	Maximum of 2 weeks
Primary	Frequency of premature ventricular contractions (PVCs)	This will be measured using a wearable EKG monitor.	Maximum of 2 weeks