Health and quality-of-life survey for people with LQTS types 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

See how LQTS types 2 and 3 affect daily life by collecting one-time questionnaires and Apple Watch/iPhone health data from adults with confirmed genetic diagnoses.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Thryv Therapeutics, Inc. (Industry-sponsored)
• Locations: 1 site (Greenville, North Carolina)
• Trial ID: NCT07075445 on ClinicalTrials.gov

What this trial studies

This is a cross-sectional observational program that will enroll up to 200 adults with genetically confirmed LQTS type 2 or 3 and a documented QTc ≥ 480 ms. Participants will receive an Apple iPhone and Apple Watch and will complete patient-reported outcome questionnaires once during a 6-month observation window while daily health metrics (sleep, activity, heart-related data) are passively recorded. There is an optional extension of up to 3 additional months during which only emotional and physical symptom surveys are collected. All participants use the myQTwave app and are assigned unique identifiers to link PROs with wearable data for analysis of disease burden and quality of life.

Who should consider this trial

Good fit: Adults aged 18 or older who are English-speaking, have a confirmed pathogenic or likely pathogenic genetic diagnosis of LQTS type 2 or 3, a documented QTc ≥ 480 ms, and can operate an iPhone and Apple Watch.

Not a fit: People without a confirmed LQTS2/3 genetic diagnosis, with QTc values below the entry threshold, unable or unwilling to use Apple devices, or currently enrolled in another drug or device trial are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the project could provide clearer, patient-centered information about symptom burden and daily-life impacts in LQTS2/3 that helps clinicians tailor care and support.

How similar studies have performed: Previous research has used wearables and patient-reported outcomes successfully in other cardiac populations, but focused quality-of-life data specifically in LQTS types 2 and 3 remain limited, so parts of this approach are relatively novel for this condition.

Eligibility criteria

Inclusion Criteria:

1. The participant is willing and provides written informed consent to participate in this study.
2. Male or female participant of at least 18 years of age, English-speaking.
3. 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.
4. Documented QTc ≥ 480 ms within the last year, demonstrated by one of the following:

   * 12-lead electrocardiogram (ECG), or
   * A signed physician's letter confirming an ECG demonstrating QTc value ≥ 480 ms.
5. 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 Criteria:

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

Where this trial is running

Greenville, North Carolina

• East Carolina University — Greenville, North Carolina, United States (Recruiting)

Study contacts

• Study coordinator: Study Coordinator

Conditions Long QT Syndrome Type 3; Long QT Syndrome 2