Effectiveness of CRD-4730 in Participants with Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)

Launched by CARDURION PHARMACEUTICALS, INC. · Aug 17, 2023

Keywords

ClinConnect Summary

This clinical trial is testing a new medication called CRD-4730 to see how safe and effective it is for people with a heart condition known as Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT). CPVT can cause the heart to beat irregularly during exercise or stress, which can be dangerous. The study will involve participants taking two different doses of the medication, as well as a placebo (a substance with no active ingredients), to help researchers understand how the drug works in the body and its effects on heart rhythm.

To participate in the trial, individuals must be at least 18 years old and have a confirmed diagnosis of CPVT based on genetic testing. They should also be stable on their heart medications for at least four weeks before joining the study. Participants will need to undergo an exercise test to assess their heart's response. Those with certain heart conditions or recent serious health issues are not eligible. Throughout the study, participants will receive careful monitoring, and their experiences will help researchers determine if CRD-4730 could be a beneficial treatment for CPVT.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Males or Females ≥18 years of age, at screening.
• • 2. Confirmed CPVT diagnosis, based on genetic screening for a known RyR2 mutation and a clinical phenotype consistent with CPVT at screening.
• • 3. The participant can perform an EST during which frequent premature ventricular contraction (PVCs) (≥10 per minute), ventricular bigeminy, or higher-grade VA (equivalent to a VA score ≥2) are identified by the investigator.
• • 4. Stable doses of any anti-arrhythmic medication, except amiodarone, for 4 weeks prior to screening.
• • 5. Adhere to all contraceptive criteria.
• Exclusion Criteria:
• • 1. Clinically significant structural heart disease, diagnosis of heart failure, or clinically significant coronary artery disease.
• • 2. History of a myocardial infarction, cerebrovascular accident, or transient ischemic attack within 3 months of screening.
• • 3. History of malignancy within the past 5 years at screening (except successfully treated basal cell carcinoma or non-metastatic squamous cell carcinoma of the skin or cervical carcinoma in situ).
• • 4. Female participant that is pregnant or lactating/ breastfeeding, or has plans to do so during the study or within 3 months following last dose of study drug.
• • 5. Use of amiodarone with 3 months prior to screening. NOTE: other protocol defined Inclusion/ Exclusion criteria may apply.