Novel Form of Acquired Long QT Syndrome

Rheumatoid Arthritis Clinical Trial

Official title:

Novel Form of Acquired Long QT Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04169100
• Other study ID #: ORD01372
• Status: Recruiting
• Phase: Phase 4
• Start date: September 28, 2011
• Est. completion date: September 30, 2024

Study information

• Verified date: April 2022
• Source: Narrows Institute for Biomedical Research
• Contact: Deana Lazaro, MD
• Phone: 7188366600
• Email: deana.lazaro[@]va.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: September 30, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Connective Tissue Diseases
• Long QT Syndrome
• Rheumatoid Arthritis
• Syndrome

Intervention

Drug:
• Prednisone
We propose to test whether QT prolongation is reversible with moderate doses of prednisone in patients with QT interval greater than 500 msec.

Locations

Country	Name	City	State
United States	VA New York Harbor Healthcare System, NY and Brooklyn Campuses	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Narrows Institute for Biomedical Research	VA New York Harbor Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Corrected QT Interval	QT interval to be measured on electrocardiogram	Baseline and at 14 days
Secondary	Change in Cytokine Levels	IL-1ß, sTNFR1, TNFa, IL-10, IL-6, and a-interferon	Baseline and at 14 days
Secondary	Change in ESR	Inflammatory Marker	Baseline and at 14 days
Secondary	Change in CRP	Inflammatory Marker	Baseline and at 14 days