Observational Study to Describe Health-Related Quality of Life and Disease Burden Among Patients With Long QT Syndrome (LQTS) 2 and 3
Thryv Therapeutics, Inc.
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.
Description
The aim of the present cross-sectional observational study is to evaluate the health status and quality of life burden in patients with LQTS. The total study duration is anticipated to last for a period of up to 18 months, including up to 6 months of each individual's observation period. The observation period may be extended by up to 3 months (total 9 months). During the optional extension, data collection via myQTwave will be limited to emotional and physical symptoms survey. This prospective cohort study will collect PRO information in a cohort of patients with LQTS 2 or 3. All screened par…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Location
- East Carolina UniversityGreenville, North Carolina