East Carolina University
Greenville, North Carolina, 27858, United States
Location status: Recruiting
Recruiting
NCT Number: NCT07075445
Observational Study to Describe Health-Related Quality of Life and Measure Disease Burden Among Patients With Long QT Syndrome Types (LQTS) 2 and 3
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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 participants will be assigned a unique identifier. Eligible participants will download the myQTwave app on the Apple iPhone and Apple Watch delivered to them after enrollment.
Patient-reported outcomes will be captured via the Apple iPhone and daily health metrics (sleep, physical and Heart-related data) will be collected using the Apple Watch.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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:
- 12-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 criteria
- 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.
Treatment and study plan
Primary outcomes
-
Quality of Life (QoL)
Time frame: Month 1
Score from the Satisfaction With Life Scale (SWLS)
-
Quality of Life (QoL)
Time frame: Month 1
Score from the Quality of Life in Life-Threatening Illness - Late Adolescents and Adults Scale (QOL-LAS)
-
Disease burden
Time frame: Month 2
Score from the CDC HRQOL-4 (Health-Related Quality of Life)
-
Disease burden
Time frame: month 2
Score from the self-reported NYHA (New York Heart Association Classification)
-
Disease burden
Time frame: Month 2
Score from the Health Actions Evaluation (HAE-10)
-
Illness perception
Time frame: Month 3
Score from the Brief Illness Perception Questionnaire (B-IPQ)
-
Illness perception
Time frame: Month 3
Score from the Illness Intrusiveness Questionnaire (IIQ)
-
Psychosocial health, including distress, social and psychological well-being, and cardiac-specific measures,
Time frame: Month 4
Score from the Depression, Anxiety, and Stress Scale-21 (DASS-21)
-
Psychosocial health, including distress, social and psychological well-being, and cardiac-specific measures,
Time frame: Month 4
Score from the UCLA 3-Item Loneliness Scale
-
Psychosocial health, including distress, social and psychological well-being, and cardiac-specific measures,
Time frame: Month 3
Score from the Multidimensional Scale of Perceived Social Support (MSPSS)
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Thryv Therapeutics, Inc.
Industry
Registry information
Official study title
Observational Study to Describe Health-Related Quality of Life and Disease Burden Among Patients With Long QT Syndrome (LQTS) 2 and 3
Important dates
- Study start
- 2025
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Jul 20, 2025
- Registry last updated
- Nov 17, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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