Purpose of this Study
This study lasts about 14 weeks and includes 8 planned visits to the clinic. If you qualify during the first part of the study, you will be randomly placed into one of three groups. Each person in the study will get two doses of a medicine called CRD-4730 and one dose that does not contain any medicine, called a placebo. The order of these doses is chosen by chance.
Each dose is given over two weeks. You will go to the clinic on the first and last day of each dose. Between each dose, there is a two-week break when you do not take any medicine. During your visits, doctors may do check-ups like physical exams, blood and urine tests, heart tests, stress tests, and more.
At home, you will use a device to check your heart every day and write down your results. You will also follow instructions for taking the medicine and keep a diary to record each time you take it.
Who Can Participate?
Eligibility
People who want to join this study must be 18 years old or older and in good overall health, except for having a confirmed diagnosis of CPVT, which is a rare heart condition. They must have been taking at least one medicine to help control irregular heartbeats for at least four weeks before the study begins.
Some people cannot join the study. This includes those who have heart failure, serious problems with the blood vessels in their heart, or high blood pressure that is not under control. These health issues could affect the study results or make it unsafe for them to participate.
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
The purpose of this Phase 2 study is to learn more about a medicine called CRD-4730 and how it works in people who have a rare heart condition called catecholaminergic polymorphic ventricular tachycardia, or CPVT. This condition causes the heart to beat too fast and in an irregular way, especially during stress or exercise.
The study will help doctors understand if CRD-4730 is safe to use, how well people can handle it, and if it helps stop the irregular heartbeats. It will also look at how the medicine moves through the body and how it affects a protein called CaMKII, which plays a role in heart rhythm problems.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
A Phase 2 Double-Blind, Repeat-Dose, Placebo-Controlled Crossover Study To Evaluate The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CRD-4730 in Participants With Catecholaminergic Polymorphic Ventricular Tachycardia
Principal Investigator
James
Daubert
Protocol Number
PRO00117223
NCT ID
NCT06658899
Phase
II
Enrollment Status
Pending Open to Enrollment