Novel Form of Acquired Long QT Syndrome
1 other identifier
interventional
25
1 country
1
Brief Summary
The goal of this study is to determine whether anti-Ro/SSA antibodies are associated with acquired QT prolongation in subjects with connective tissue disease. The investigators will investigate whether gender or race influence correlation between anti-Ro antibody status and prolonged QT interval and the role of inflammatory cytokines in association with anti-Ro antibodies and QT prolongation. The investigators propose to add an additional objective to test whether QT prolongation is reversible with moderate doses of prednisone in patients with QT interval greater than 500 msec.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Sep 2011
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 28, 2011
CompletedFirst Submitted
Initial submission to the registry
November 14, 2019
CompletedFirst Posted
Study publicly available on registry
November 19, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2024
CompletedApril 11, 2022
April 1, 2022
12.5 years
November 14, 2019
April 7, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Corrected QT Interval
QT interval to be measured on electrocardiogram
Baseline and at 14 days
Secondary Outcomes (3)
Change in Cytokine Levels
Baseline and at 14 days
Change in ESR
Baseline and at 14 days
Change in CRP
Baseline and at 14 days
Study Arms (1)
Prednisone Group
EXPERIMENTALThese patients have CTD and QTc over 500 msec. Prednisone is administered as a preventative measure against arrhythmia via QTc shortening.
Interventions
We propose to test whether QT prolongation is reversible with moderate doses of prednisone in patients with QT interval greater than 500 msec.
Eligibility Criteria
You may qualify if:
- \- Patients enrolled in New York Harbor Healthcare System with connective tissue disease
You may not qualify if:
- Atrial fibrillation
- Intraventricular conduction delay with wide QRS complex
- Acute medical conditions
- Drug overdose
- Hypothermia
- Known diagnosis or family history of hereditary Long QT syndrome, complete bundle brunch block, ventricular paced rhythm, profound bradycardia and tachycardia, and uncorrected hypothyroidism
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA New York Harbor Healthcare System, NY and Brooklyn Campuses
New York, New York, 11209, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief of Rheumatology
Study Record Dates
First Submitted
November 14, 2019
First Posted
November 19, 2019
Study Start
September 28, 2011
Primary Completion
March 31, 2024
Study Completion
September 30, 2024
Last Updated
April 11, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data will be made available from the time of publication and will be kept for a minimum of 5 years.
- Access Criteria
- Data will be shared upon written request to the principal investigator.
De-identified can be shared upon request. We do not anticipate the generation or development of any model organism or unique reagent from this study. If any new model organism or reagent is generated then we will make them available to other researchers upon request via the VA New York Harbor Healthcare System Technology Transfer office.