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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT04169100
Date of registration: 14/11/2019
Prospective Registration: No
Primary sponsor: Narrows Institute for Biomedical Research
Public title: Novel Form of Acquired Long QT Syndrome
Scientific title: Novel Form of Acquired Long QT Syndrome
Date of first enrolment: September 28, 2011
Target sample size: 25
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT04169100
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: None (Open Label).  
Phase:  Phase 4
Countries of recruitment
United States
Contacts
Name:     Deana Lazaro, MD
Address: 
Telephone: 718-836-6600
Email: deana.lazaro@va.gov
Affiliation: 
Name:     Deana Lazaro, MD
Address: 
Telephone: 7188366600
Email: deana.lazaro@va.org
Affiliation: 
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 89 Years
Gender: All
Health Condition(s) or Problem(s) studied
Connective Tissue Diseases
Long QT Syndrome
Rheumatoid Arthritis
Intervention(s)
Drug: Prednisone
Primary Outcome(s)
Change in Corrected QT Interval [Time Frame: Baseline and at 14 days]
Secondary Outcome(s)
Change in CRP [Time Frame: Baseline and at 14 days]
Change in Cytokine Levels [Time Frame: Baseline and at 14 days]
Change in ESR [Time Frame: Baseline and at 14 days]
Secondary ID(s)
ORD01372
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
VA New York Harbor Healthcare System
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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