Phase 4
N=1
Diltiazem in Jervell and Lange-Nielsen Syndrome
Jervell and Lange Nielsen Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT06534671 ↗Enrolled (actual)
1
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcome: Primary: QT Interval — 623 ms
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- diltiazem (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University Medical Center
- Primary completion
- Oct 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY QT Interval |
570 | — |
| PRIMARY QT Interval |
570 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Age greater than 18 years
- Genetically confirmed diagnosis of Jervell and Lange-Nielsen syndrome
- Able to provide written informed consent
Exclusion Criteria
- Known hypersensitivity to diltiazem
- Pregnancy
- Congestive heart failure, angina, preexcitation, or chronic obstructive pulmonary disease
- Sick sinus syndrome or atrioventricular block in the absence of a pacemaker/defibrillator
- Any clinically significant ongoing medical or surgical condition that might jeopardize the subject's safety or interfere with the conduct of the study in the judgement of the investigator
- Baseline systolic blood pressure less than 100 Hg or diastolic blood pressure less than 60 Hg
Data sourced from ClinicalTrials.gov (NCT06534671). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.