Recruiting

Observational Study

Sponsor:

Thryv Therapeutics, Inc.

Code:

NCT07075445

Conditions

Long QT Syndrome Type 3

Long QT Syndrome 2

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT07075445

Start date

Oct 27, 2025

Status verified date

Nov, 2025

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Quality of Life (QoL) [ Time Frame: Month 1 ]
  • Quality of Life (QoL) [ Time Frame: Month 1 ]
  • Disease burden [ Time Frame: Month 2 ]
  • Disease burden [ Time Frame: month 2 ]
  • Disease burden [ Time Frame: Month 2 ]
  • Illness perception [ Time Frame: Month 3 ]
  • Illness perception [ Time Frame: Month 3 ]
  • Psychosocial health, including distress, social and psychological well-being, and cardiac-specific measures, [ Time Frame: Month 4 ]
  • Psychosocial health, including distress, social and psychological well-being, and cardiac-specific measures, [ Time Frame: Month 4 ]
  • Psychosocial health, including distress, social and psychological well-being, and cardiac-specific measures, [ Time Frame: Month 3 ]

Central Contacts and Locations

Central contacts

Locations

East Carolina University

Recruiting

Greenville, North Carolina, United States, 27858

More Information

Sponsor

Thryv Therapeutics, Inc.

Last update posted

Nov 17, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Thryv Therapeutics, Inc. on 2025-11-17.