Study on the Safety and Effects 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 condition known as Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT). CPVT is a rare heart rhythm disorder that can cause irregular heartbeats, especially during physical activity or stress. The study will evaluate a new treatment called CRD-4730, which is a tablet designed to help manage this condition. CRD-4730 works as a small molecule inhibitor, targeting specific proteins involved in heart rhythm regulation.

The purpose of the study is to assess the safety and tolerability of CRD-4730 in individuals with CPVT. Participants will receive either the CRD-4730 tablet or a matching placebo. The study is designed as a crossover trial, meaning participants will receive both the treatment and the placebo at different times. This approach helps researchers compare the effects of the actual medication against the placebo. The study will involve repeated doses of the medication over a period of time, allowing researchers to monitor how the body processes the drug and its impact on heart rhythm.

Throughout the study, participants will be closely monitored for any side effects or changes in their condition. The trial aims to provide valuable information on how CRD-4730 can be used to improve the management of CPVT, potentially offering a new treatment option for those affected by this challenging condition.

1 initial visit

Upon joining the study, you will attend an initial visit. During this visit, your general health will be assessed through medical history, laboratory tests, vital sign measurements, and a physical examination. An electrocardiogram (ECG) will also be performed to check your heart’s electrical activity.

2 medication administration

You will be given a medication called CRD-4730 or a placebo, which looks like the medication but does not contain the active ingredient. The medication is in the form of a tablet and is taken orally. The exact dosage and frequency will be provided by the study team.

3 treatment period

During the treatment period, you will take the medication as instructed. This period involves repeated doses over a specified timeframe. The study team will monitor your health and any changes in your condition.

4 follow-up visits

You will have follow-up visits where the study team will assess the safety and tolerability of the medication. These visits will include health assessments similar to the initial visit, such as ECGs and laboratory tests.

5 end of study

At the end of the study, a final assessment will be conducted. This will include a review of your health status and any effects of the medication. The study team will provide you with information about the next steps and any necessary follow-up care.

Who Can Join the Study?

The participant must be able to understand and sign a consent form, agreeing to follow the study rules.
The participant must be a male or female who is at least 18 years old and considered an adult by local laws.
The participant should be in good general health, except for their diagnosis of Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT). This will be checked through medical history, lab tests, heart tests, and a physical exam.
The participant must have a confirmed diagnosis of CPVT, based on genetic testing for a specific mutation and symptoms that match CPVT. Previous genetic test results are acceptable if confirmed by the study doctor.
The participant must be able to perform an exercise stress test (EST) where certain heart rhythm issues are identified by the study doctor.
The participant must have been on a stable dose of at least one heart rhythm medication (excluding amiodarone) for four weeks before the study, unless they couldn’t tolerate such medications before.
Female participants must meet one of the following:
- Be postmenopausal, meaning no menstrual periods for 12 months and a specific hormone level is met.
- Be permanently sterile, meaning unable to have children due to surgery.
- Agree to use one highly effective birth control method and one additional barrier method until a certain time after the last dose of the study drug.
- Have a sterilized male partner, meaning the partner cannot father children.
- Agree to practice true abstinence, meaning no sexual activity.
Male participants must meet one of the following:
- Be sterilized, meaning unable to father children due to surgery, and agree to use a condom for a certain time after the last dose of the study drug.
- Agree to use a condom if their partner can become pregnant, and ensure the partner uses a highly effective birth control method during this time.
- Agree to use a condom if their partner cannot become pregnant, for a certain time after the last dose of the study drug.
- Agree not to donate sperm from the start of the study until a certain time after the last dose of the study drug.
- Agree to practice true abstinence, meaning no sexual activity, and not donate sperm during the study period.

Who Cannot Join the Study?

Participants cannot have any other serious heart conditions besides Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT).
Participants should not have any severe medical conditions that could interfere with the study.
Participants must not be taking any medications that could affect the study results.
Participants should not have a history of drug or alcohol abuse.
Participants must not be pregnant or breastfeeding.
Participants should not have participated in another clinical trial recently.
Participants must not have any allergies to the study medication or its ingredients.
Participants should not have any mental health conditions that could affect their ability to participate in the study.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Hospital Sant Joan De Deu Barcelona	Esplugues De Llobregat	Spain
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
Arvzssvpi Uvd	Amsterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.01.2026
Italy	Recruiting	01.01.2026
Spain	Recruiting	01.01.2026
The Netherlands	Recruiting	01.01.2026

Trial locations

Investigated drugs:

Crd-4730

CRD-4730 is a medication being studied for its potential to help people with a heart condition called catecholaminergic polymorphic ventricular tachycardia (CPVT). This condition can cause irregular heartbeats, especially during physical activity or stress. The medication is being tested to see if it is safe and well-tolerated when taken multiple times. Researchers are also looking at how the body processes the medication and how it affects the heart. The goal is to find out if CRD-4730 can help manage the symptoms of CPVT and improve the quality of life for those affected by this condition.

Investigated diseases:

Ventricular tachycardia

Catecholaminergic Polymorphic Ventricular Tachycardia – This is a genetic heart condition characterized by an abnormal heart rhythm, known as ventricular tachycardia, which is triggered by physical activity or stress. The condition is caused by mutations in genes that affect calcium regulation in heart cells. During episodes, the heart beats rapidly and irregularly, which can lead to dizziness or fainting. The arrhythmias typically occur in the absence of structural heart disease and are not present at rest. Over time, repeated episodes can lead to more frequent symptoms. The condition is often diagnosed in childhood or adolescence.

Trial ID:

2024-515564-32-00

Protocol code:

CRD-4730-202

NCT ID:

NCT06658899

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?