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CRD-4730 for Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT Trial)

Phase 2

Recruiting

Research Sponsored by Cardurion Pharmaceuticals, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Confirmed CPVT diagnosis, based on genetic screening for a known RyR2 mutation and a clinical phenotype consistent with CPVT at screening.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to day 22

Awards & highlights

CPVT Trial Summary

This trial studies the safety, PK & PD of CRD-4730 to treat Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT) in 2 cohorts of participants receiving single doses.

Who is the study for?

Adults over 18 with confirmed CPVT, a heart condition causing irregular rapid heartbeats, can join. They must be able to do an exercise test and have been on stable doses of anti-arrhythmic meds (except amiodarone) for 4 weeks. Participants need to follow strict birth control rules.Check my eligibility

What is being tested?

The trial tests CRD-4730's safety and effects in people with CPVT compared to a placebo. It's double-blind, meaning neither the participants nor the researchers know who gets the real drug or placebo during the study.See study design

What are the potential side effects?

Specific side effects aren't listed but generally may include issues related to how well CRD-4730 is tolerated by patients' bodies and its interaction with their current medications.

CPVT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with CPVT through genetic testing and clinical assessment.

CPVT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to day 22

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to day 22

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to day 22 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Changes in Electrocardiogram (ECG) Measurements

Changes in Laboratory Assessments

Changes in Physical Exam

+5 more

Secondary outcome measures

Assessment of PK effect

Change in Ventricular Arrhythmia (VA) score during Exercise Stress Test (EST)

CPVT Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Dose 2Experimental Treatment1 Intervention

CRD-4730 Dose 2 capsule

Group II: Dose 1Experimental Treatment1 Intervention

CRD-4730 Dose 1 capsule

Group III: Dose 3Placebo Group1 Intervention

Placebo capsule to match CRD-4730

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Cardurion Pharmaceuticals, Inc.Lead Sponsor

4 Previous Clinical Trials

720 Total Patients Enrolled

Jason Homsy, M.D., Ph.D.Study DirectorExecutive Medical Director

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is Dose 2 considered to be a risk-free treatment for patients?

"The safety of Dose 2 was scored as a 2, since this clinical trial is in the Phase 2 realm and thus only has evidence backing its protective nature without any efficacy data."

Answered by AI

Are there still opportunities to partake in this trial for participants?

"Affirmative. The clinical trial's information on the website of clinicaltrials.gov affirms that this trial is currently recruiting participants; it was first posted on November 7th 2023 and most recently modified on November 21st 2023. There are 12 individuals needed to be recruited from a single medical facility."

Answered by AI

Are elderly individuals permitted to participate in this trial?

"This clinical trial is enrolling individuals of age 18 and older up to 99 years old."

Answered by AI

How many participants are currently being accepted into this research?

"Affirmative. Clinicaltrials.gov data confirms that this trial, which first appeared online on November 7th 2023, is in the process of recruiting patients for participation. A total of 12 individuals are needed from one medical site."

Answered by AI

Could I potentially be accepted into this research study?

"This clinical trial is accepting 12 individuals diagnosed with ventricular tachycardia aged 18 to 99. Patients must meet the following requirements in order to be eligible: Ability to pass an Exercise Stress Test (EST) during which exercise-induced ventricular couplets or higher-grade VA (equivalent to a VA score ≥3) are detected, Stable doses of any antiarrhythmic medication, except amiodarone, for 4 weeks prior to screening., Gender identification as Male or Female and not below 18 years old at time of screening., Confirmed CPVT diagnosis based on genetic testing for a recognized RyR2 mutation and"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Effectiveness of CRD-4730 in Participants With Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06005428.