Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06534671
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-07-29
Brief Title:
Diltiazem in Jervell and Lange-Nielsen Syndrome
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Diltiazem in Jervell and Lange-Nielsen Syndrome
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
Subjects will be recruited by study personnel and will be scheduled for a single outpatient visit If an implanted cardiac device pacemaker or ICD is in place it will be interrogated to ensure no recent rhythm abnormalities Just prior to administering diltiazem an ECG and BP will be obtained If baseline SBP is 100 mm Hg or DBP 60 mm Hg the study will be terminated A single dose of IV diltiazem 025 mgkg over 2 minutes will be administered with 12-lead ECG and BP obtained at 2 5 7 10 15 and 20 minutes If at 10 minutes there has been no QT shortening and the SBP is stable 20 drop from baseline and 100 mm Hg a repeat dose 035 mgkg will be given at 15 minutes with 12-lead ECG and BP obtained at 17 20 22 25 30 and 35 minutes After 20 minutes single dose or 35 minutes 2 doses the test will end and the subject will remain on continuous telemetry for 2 hours Prior to discharge the IV will be removed The primary analysis will be a repeated measures paired comparison of the QTc at baseline and following diltiazem
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None