Diltiazem in Jervell and Lange-Nielsen Syndrome
NCT06534671 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1
Last updated 2025-10-14
Summary
This study will test the effect of diltiazem, a calcium channel blocking drug, on the QT interval in patients with Jervell and Lange-Nielsen syndrome. This will be a single IV dose and acute effects (within minutes) will be observed.
Conditions
- Jervell and Lange Nielsen Syndrome
Interventions
- DRUG
-
diltiazem
IV diltiazem (0.25 mg/kg) will be given over 2 minutes, with ECG and blood pressure measurements at baseline, 2, 5, 7, 10, 15 and 20 minutes. If at 10 minutes there is no QT shortening, and blood pressure is stable, an additional dose (0.35 mg/kg) will be given with ECG and blood pressure measurements at 17, 20, 22, 25, 30 and 35 minutes.
Sponsors & Collaborators
-
Vanderbilt University Medical Center
lead OTHER
Principal Investigators
-
Prince J Kannankeril, MD, MSCI · Vanderbilt University Medical Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-10-16
- Primary Completion
- 2024-10-23
- Completion
- 2024-10-23
- FDA Drug
- Yes
Countries
- United States
Study Locations
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