Observational Study to Describe Health-Related Quality of Life and Measure Disease Burden Among Patients With Long QT Syndrome Types (LQTS) 2 and 3
Trial Parameters
Eligibility Fast-Check
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Brief 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 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 t