Long QT Syndrome Type 3NCT07075445
Observational Study to Describe Health-Related Quality of Life and Measure Disease Burden Among Patients With Long QT Syndrome Types (LQTS) 2 and 3
An observational study of Long QT Syndrome Type 3 and Long QT Syndrome 2, run by Thryv Therapeutics, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Long QT Syndrome Type 3, Long QT Syndrome 2
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Oct 2025to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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:
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
East Carolina University
Greenville, North Carolina, 27858
About this study
Official title: Observational Study to Describe Health-Related Quality of Life and Disease Burden Among Patients With Long QT Syndrome (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.
Read the detailed 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 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.
- Conditions
- Long QT Syndrome Type 3, Long QT Syndrome 2
- Medical subject headings
- Long QT syndrome type 3, Long Qt Syndrome 2
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life (QoL)
Score from the Satisfaction With Life Scale (SWLS)
Measured: Month 1
Quality of Life (QoL)
Score from the Quality of Life in Life-Threatening Illness - Late Adolescents and Adults Scale (QOL-LAS)
Measured: Month 1
Disease burden
Score from the CDC HRQOL-4 (Health-Related Quality of Life)
Measured: Month 2
Disease burden
Score from the self-reported NYHA (New York Heart Association Classification)
Measured: month 2
Disease burden
Score from the Health Actions Evaluation (HAE-10)
Measured: Month 2
Illness perception
Score from the Brief Illness Perception Questionnaire (B-IPQ)
Measured: Month 3
Illness perception
Score from the Illness Intrusiveness Questionnaire (IIQ)
Measured: 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)
Measured: Month 4
Psychosocial health, including distress, social and psychological well-being, and cardiac-specific measures,
Score from the UCLA 3-Item Loneliness Scale
Measured: 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)
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start27 Oct 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long QT Syndrome Type 3Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thryv Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07075445
- Sponsor's protocol ID
- Thryv Therapeutics Inc.
- Status last verified
- Nov 2025
- First submitted
- 10 Jul 2025
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study to Describe Health-Related Quality of Life and Disease Burden Among Patients With Long QT Syndrome (LQTS) 2 and 3
- ClinicalTrials.gov ID
- NCT07075445
- Acronym / sponsor ID
- Thryv Therapeutics Inc.
- Conditions
- Long QT Syndrome Type 3, Long QT Syndrome 2
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Thryv Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Oct 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 20 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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:
- Documented QTc ≥ 480 ms within the last year, demonstrated by one of the following:
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Long QT Syndrome Type 3 and Long QT Syndrome 2, run by Thryv Therapeutics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life (QoL) (time frame: Month 1). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.