Diltiazem in Jervell and Lange-Nielsen Syndrome

NCT06534671 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 240535
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Jervell and Lange Nielsen Syndrome

Keywords

Long QT syndrome

Outcome Measures

Primary Outcomes (2)

• QT Interval

  QT interval (on 12-lead ECG) in ms

  Baseline

• QT Interval

  QT interval (on 12-lead ECG) in ms

  5 minutes

Study Arms (1)

Diltiazem

EXPERIMENTAL

IV diltiazem (0.25 mg/kg) will be given over 2 minutes. A second IV dose (0.35 mg/kg) may be given at 10 minutes.

Drug: diltiazem

Interventions

diltiazem DRUG

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.

Diltiazem

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than 18 years
• Genetically confirmed diagnosis of Jervell and Lange-Nielsen syndrome
• Able to provide written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Jervell-Lange Nielsen Syndrome; Long QT Syndrome

Interventions

Diltiazem

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Heart Defects, Congenital; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Prince J. Kannankeril, MD, MSCI
• Organization: Vanderbilt University Medical Center

prince.kannankeril@vumc.org

(615) 322-7447

Study Officials

• Prince J Kannankeril, MD, MSCI

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 2, 2024
• Study Start: October 16, 2024
• Primary Completion: October 23, 2024
• Study Completion: October 23, 2024
• Last Updated: October 14, 2025
• Results First Posted: October 14, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data requests can be submitted immediately after article publication and the data will be made accessible for up to 36 months.
• Access Criteria: Access may be requested by qualified researchers and will be provided following review and approval of a research proposal and execution of a Data Use Agreement.

Locations

US (1)