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Calcium Channel Blocker

Diltiazem for Long QT Syndrome

Phase 4
Waitlist Available
Led By Prince J Kannankeril, MD, MSCI
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Genetically confirmed diagnosis of Jervell and Lange-Nielsen syndrome
Age greater than 18 years
Must not have
Sick sinus syndrome or atrioventricular block in the absence of a pacemaker/defibrillator
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights

Summary

"This trial will see how a drug called diltiazem affects the QT interval in patients with Jervell and Lange-Nielsen syndrome. Patients will receive a single dose through an IV, and

Who is the study for?
This trial is for patients with Jervell and Lange-Nielsen Syndrome, a rare condition that causes long QT intervals on an EKG. Participants should have this specific syndrome to join the study.
What is being tested?
The trial is examining how diltiazem, a medication that affects heart muscle cells, influences the QT interval in patients with Jervell and Lange-Nielsen Syndrome after a single IV dose.
What are the potential side effects?
Diltiazem may cause side effects such as low blood pressure, slow heartbeat, dizziness, fatigue, nausea, and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My condition is genetically confirmed as Jervell and Lange-Nielsen syndrome.
Select...
I am older than 18 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a heart rhythm problem but don't have a pacemaker.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
QT interval

Side effects data

From 2014 Phase 1 trial • 22 Patients • NCT02319148
67%
Headache
33%
Spontaneous penile erection
33%
Hot flush
17%
Flatulence
17%
Nausea
100%
80%
60%
40%
20%
0%
Study treatment Arm
PF-00489791 20 mg + Diltiazem 240 mg
PF-00489791 20 mg + Verapamil 240 mg
PF-00489791 20 mg
Itraconazole 200 mg
Diltiazem 240 mg
Verapamil 240 mg
PF-00489791 20 mg + Itraconazole 200 mg

Trial Design

1Treatment groups
Experimental Treatment
Group I: DiltiazemExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
diltiazem
2014
Completed Phase 1
~30

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
888 Previous Clinical Trials
934,932 Total Patients Enrolled
Prince J Kannankeril, MD, MSCIPrincipal InvestigatorVanderbilt University Medical Center
2 Previous Clinical Trials
20 Total Patients Enrolled
~1 spots leftby Jul 2025
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