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

NCT07075445 | Recruiting

• 1 other identifier: Thryv Therapeutics Inc.
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Long QT Syndrome Type 3; Long QT Syndrome 2

Outcome Measures

Primary Outcomes (10)

• Quality of Life (QoL)

  Score from the Satisfaction With Life Scale (SWLS)

  Month 1

• Quality of Life (QoL)

  Score from the Quality of Life in Life-Threatening Illness - Late Adolescents and Adults Scale (QOL-LAS)

  Month 1

• Disease burden

  Score from the CDC HRQOL-4 (Health-Related Quality of Life)

  Month 2

• Disease burden

  Score from the self-reported NYHA (New York Heart Association Classification)

  month 2

• Disease burden

  Score from the Health Actions Evaluation (HAE-10)

  Month 2

• Illness perception

  Score from the Brief Illness Perception Questionnaire (B-IPQ)

  Month 3

• Illness perception

  Score from the Illness Intrusiveness Questionnaire (IIQ)

  Month 3

• Psychosocial health, including distress, social and psychological well-being, and cardiac-specific measures,

  Score from the Depression, Anxiety, and Stress Scale-21 (DASS-21)

  Month 4

• Psychosocial health, including distress, social and psychological well-being, and cardiac-specific measures,

  Score from the UCLA 3-Item Loneliness Scale

  Month 4

• Psychosocial health, including distress, social and psychological well-being, and cardiac-specific measures,

  Score from the Multidimensional Scale of Perceived Social Support (MSPSS)

  Month 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from cardiology and genetic clinics at academic and private medical centers across the United States, as well as through outreach efforts targeting individuals and families affected by inherited arrhythmia conditions. This includes engagement through community-based initiatives. The study population includes individuals with a genetically confirmed diagnosis of Long QT Syndrome type 2 or 3.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Thryv Therapeutics, Inc.: lead

Study Sites (1)

East Carolina University

Greenville, North Carolina, 27858, United States

RECRUITING

MeSH Terms

Conditions

Long QT syndrome type 3; Long Qt Syndrome 2

Central Study Contacts

Study Coordinator

CONTACT

252-955-4157; coordinator@myqtwave.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: July 20, 2025
• Study Start: October 27, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 17, 2025

Record last verified: 2025-11

Locations

US (1)