RecruitingNCT07075445

Observational Study to Describe Health-Related Quality of Life and Measure Disease Burden Among Patients With Long QT Syndrome Types (LQTS) 2 and 3

Observational Study to Describe Health-Related Quality of Life and Disease Burden Among Patients With Long QT Syndrome (LQTS) 2 and 3


Sponsor

Thryv Therapeutics, Inc.

Enrollment

200 participants

Start Date

Oct 27, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

This is a cross-sectional observational study designed to assess the disease burden and quality of life in individuals with LQTS 2 and 3. Each participant will answer each patient-reported outcome questionnaire only once over a 6-month period. The study will enroll up to 200 participants.


Eligibility

Min Age: 18 Years

Inclusion Criteria9

  • The participant is willing and provides written informed consent to participate in this study.
  • Male or female participant of at least 18 years of age, English-speaking.
  • Confirmed genetic diagnosis of LQT2 or 3, demonstrated by one of the following:
  • Genetic testing report (pathogenic or likely pathogenic (P/LP) mutation) in KCHN2 or SCN5a genes) or,
  • A signed physician's letter confirming genetic diagnosis of LQTS 2 or 3.
  • Documented QTc ≥ 480 ms within the last year, demonstrated by one of the following:
  • -lead electrocardiogram (ECG), or
  • A signed physician's letter confirming an ECG demonstrating QTc value ≥ 480 ms.
  • The participant is able to operate a smartphone and a companion watch. *The number of participants with QTc between 480 and 500 ms will be limited to 50.

Exclusion Criteria4

  • Current participation in another clinical trial involving a drug or device.
  • Participants unwilling to use an iPhone or Apple Watch for the duration of the study.
  • Known diagnosis of Brugada Syndrome
  • Participants unwilling to comply with outlined procedures.

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Locations(1)

East Carolina University

Greenville, North Carolina, United States

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NCT07075445