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Study on the Safety of CRD-4730 for Patients with Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a heart condition called Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT). CPVT is a rare genetic disorder that can cause irregular heartbeats, especially during physical activity or stress. The study will test a new treatment called CRD-4730, which is taken as a capsule. The purpose of the study is to evaluate the safety and tolerability of CRD-4730 in people with CPVT.

Participants in the study will receive either the CRD-4730 capsule or a placebo. The study is designed to be "blinded," meaning that neither the participants nor the investigators will know who is receiving the actual medication and who is receiving the placebo. This helps ensure that the results are unbiased. The study will monitor participants over a period of time to observe any side effects and to measure how the body processes the medication.

Throughout the study, participants will undergo various tests, including blood tests and heart monitoring, to assess their health and the effects of the medication. The study aims to gather information on how CRD-4730 affects heart rhythm and its overall safety in treating CPVT. This research could potentially lead to new treatment options for individuals living with this challenging heart condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a confirmed diagnosis of catecholaminergic polymorphic ventricular tachycardia (CPVT) through genetic screening and clinical evaluation.

    Participants must be at least 18 years old and have been on a stable dose of anti-arrhythmic medication, excluding amiodarone, for at least four weeks prior to the assessment.

  2. Step 2

    Baseline evaluation

    A baseline evaluation is performed to establish initial health metrics. This includes clinical laboratory tests, vital sign measurements, a 12-lead electrocardiogram (ECG), and a physical examination.

    Participants will also undergo an exercise stress test (EST) to identify specific heart rhythm irregularities.

  3. Step 3

    Medication administration

    Participants receive the study medication, CRD-4730, in capsule form. The medication is taken orally.

    The dosage and frequency of administration are determined by the study protocol and are monitored throughout the trial.

  4. Step 4

    Monitoring and follow-up

    Participants are monitored for any adverse events and changes in health status. This includes regular clinical laboratory tests, vital sign checks, ECGs, and physical examinations.

    The study evaluates changes in ventricular arrhythmia (VA) scores at specified intervals: from baseline to Day 1, Day 8, and Day 15.

  5. Step 5

    Completion of study

    The study concludes with a final assessment to evaluate the overall safety and tolerability of CRD-4730.

    Participants' plasma concentrations of the medication are measured over time to assess pharmacokinetics.

Who can join the trial?

5 criteria

  • The participant must be a male or female who is at least 18 years old.
  • The participant must have a confirmed diagnosis of **Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)**. This is based on genetic testing for a known **RyR2 mutation** and symptoms that match CPVT. Previous genetic test results are acceptable if confirmed by the study doctor and recorded in the study documents.
  • The participant must be able to perform an **Exercise Stress Test (EST)**. During this test, the doctor should identify frequent **premature ventricular contractions (PVCs)**, which are extra heartbeats, at a rate of 10 or more per minute, or other specific heart rhythm issues.
  • The participant must have been taking a stable dose of any heart rhythm medication, except **amiodarone**, for at least 4 weeks before the study starts.
  • The participant must agree to follow all birth control requirements during the study.

Who cannot join the trial?

7 criteria

  • Participants who have any other serious heart conditions besides **Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)**. This is a specific heart rhythm disorder.
  • Individuals who are currently taking medications that might interfere with the study drug.
  • People with a history of severe allergic reactions to medications.
  • Participants who have any other medical conditions that the study doctors believe would make it unsafe for them to participate.
  • Women who are pregnant or breastfeeding.
  • Individuals who are unable to follow the study procedures or attend the required visits.
  • Participants who have been part of another clinical trial recently.
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Investigated drugs

CRD-4730 is an investigational medication being studied for its safety and tolerability in people with Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT). This condition is a type of irregular heartbeat that can be triggered by physical activity or stress. The trial aims to understand how the body processes this medication and its effects on the heart's rhythm.

What is already known about the treatment

CRD-4730 – This medication is currently being studied in a clinical trial for its safety and tolerability in individuals with Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT). It is administered orally, and the trial is in Phase 2A, which means it is still in the early stages of testing in humans. The main therapeutic indication for CRD-4730 is to manage CPVT, a condition characterized by irregular heartbeats triggered by physical activity or stress. The medication works by targeting specific molecular pathways involved in heart rhythm regulation, although the exact mechanism of action is still under investigation. It is classified pharmacologically as an investigational drug, as it is not yet approved for general medical use.

Investigated diseases

Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT) – This is a rare genetic heart condition characterized by an abnormal heart rhythm that can occur during physical activity or emotional stress. It is caused by mutations in genes that affect calcium handling in heart cells, leading to irregular heartbeats. The condition typically presents in childhood or adolescence, and symptoms may include dizziness, fainting, or palpitations. During episodes, the heart's electrical system malfunctions, causing rapid and chaotic heartbeats. These episodes can be triggered by exercise or stress, and they may resolve on their own or require medical intervention. CPVT is a chronic condition that requires careful management to prevent episodes.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-502845-83-00Protocol codeCRD-4730-201Estimated enrolment14 patientsSponsorCardurion Pharmaceuticals Inc.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).