Novel Form of Acquired Long QT Syndrome
Primary Purpose
Long QT Syndrome, Connective Tissue Diseases, Rheumatoid Arthritis
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Prednisone
Sponsored by
About this trial
This is an interventional prevention trial for Long QT Syndrome focused on measuring cytokines
Eligibility Criteria
Inclusion Criteria:
- Patients enrolled in New York Harbor Healthcare System with connective tissue disease
Exclusion Criteria:
- 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
Sites / Locations
- VA New York Harbor Healthcare System, NY and Brooklyn CampusesRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Prednisone Group
Arm Description
These patients have CTD and QTc over 500 msec. Prednisone is administered as a preventative measure against arrhythmia via QTc shortening.
Outcomes
Primary Outcome Measures
Change in Corrected QT Interval
QT interval to be measured on electrocardiogram
Secondary Outcome Measures
Change in Cytokine Levels
IL-1β, sTNFR1, TNFα, IL-10, IL-6, and α-interferon
Change in ESR
Inflammatory Marker
Change in CRP
Inflammatory Marker
Full Information
NCT ID
NCT04169100
First Posted
November 14, 2019
Last Updated
April 7, 2022
Sponsor
Narrows Institute for Biomedical Research
Collaborators
VA New York Harbor Healthcare System
1. Study Identification
Unique Protocol Identification Number
NCT04169100
Brief Title
Novel Form of Acquired Long QT Syndrome
Official Title
Novel Form of Acquired Long QT Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 28, 2011 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Narrows Institute for Biomedical Research
Collaborators
VA New York Harbor Healthcare System
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
There are two parts to this study. First, the investigators propose a prospective, observational study of subjects with connective tissue disease (CTD). Data on CTD diagnosis, disease activity, medications, electrolytes, anti-Ro Ab status, QT interval and serum for measurement of inflammatory markers and cytokines will be collected. Please see the research strategy for details of the protocol. The investigators expect that QTc prolongation will have a positive correlation with anti-Ro Ab positivity, elevated measures of inflammatory markers and higher levels of inflammatory cytokines, especially IL-6.
The second part of the study will include a subgroup of subjects who have QTc prolongation of more than 500 milliseconds. This is a proof of concept study to investigate whether immunosuppressive treatment with moderate dose of prednisone will reduce QTc in CTD patients exhibiting an excessive QTc prolongation of >500msec. Patients enrolled in the prospective observational study with QTc prolongation of more than 500 msec will receive oral prednisone 40mg daily for 3 days followed by 20mg for eleven days (a total of 2 weeks) with the goal to shorten or normalize the prolonged QTc. Other factors that may cause prolonged QTc will be evaluated and corrected as needed. Inflammatory markers, cytokines, and QTc will be measured at baseline and serially at days 3 and 14 (end of treatment). The investigators will monitor changes in QTc during three 24-hour periods during treatment at baseline, day 3 and day 14. Risks of prednisone include elevated serum glucose levels, edema, increased risk of infection and blood pressure elevation. The dosage and duration of prednisone used in this study is similar to that given for a severe allergic reaction. The PI will monitor the patients for potential side effects which will immediately be addressed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Long QT Syndrome, Connective Tissue Diseases, Rheumatoid Arthritis
Keywords
cytokines
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Single group, Preventative care, Proof of concept study
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Prednisone Group
Arm Type
Experimental
Arm Description
These patients have CTD and QTc over 500 msec. Prednisone is administered as a preventative measure against arrhythmia via QTc shortening.
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
We propose to test whether QT prolongation is reversible with moderate doses of prednisone in patients with QT interval greater than 500 msec.
Primary Outcome Measure Information:
Title
Change in Corrected QT Interval
Description
QT interval to be measured on electrocardiogram
Time Frame
Baseline and at 14 days
Secondary Outcome Measure Information:
Title
Change in Cytokine Levels
Description
IL-1β, sTNFR1, TNFα, IL-10, IL-6, and α-interferon
Time Frame
Baseline and at 14 days
Title
Change in ESR
Description
Inflammatory Marker
Time Frame
Baseline and at 14 days
Title
Change in CRP
Description
Inflammatory Marker
Time Frame
Baseline and at 14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- Patients enrolled in New York Harbor Healthcare System with connective tissue disease
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Deana Lazaro, MD
Phone
7188366600
Ext
3198
Email
deana.lazaro@va.org
Facility Information:
Facility Name
VA New York Harbor Healthcare System, NY and Brooklyn Campuses
City
New York
State/Province
New York
ZIP/Postal Code
11209
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deana Lazaro, MD
Phone
718-836-6600
Ext
3198
Email
deana.lazaro@va.gov
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Data will be made available from the time of publication and will be kept for a minimum of 5 years.
IPD Sharing Access Criteria
Data will be shared upon written request to the principal investigator.
Learn more about this trial
Novel Form of Acquired Long QT Syndrome
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