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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Nantes Nantes France
Fondazione Salvatore Maugeri Clinica Del Lavoro E Della Riabilitazione Pavia Italy
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
29.03.2024
Italy Italy
Not recruiting
29.03.2024

Trial locations

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.

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 ID:
2022-502845-83-00
Protocol code:
CRD-4730-201
NCT ID:
NCT06005428
Trial Phase:
Therapeutic exploratory (Phase II)

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