Catecholaminergic Polymorphic Ventricular TachycardiaPhase 2CPVTNCT06658899
A Phase 2 Study of CRD-4730 in CPVT
A Phase 2 study testing CRD-4730 in people with Catecholaminergic Polymorphic Ventricular Tachycardia, run by Cardurion Pharmaceuticals, Inc. at 12 sites in 6 countries.
Trial summary
This is a Phase 2, multicenter, double-blind, sponsor blinded, placebo-controlled, repeat-dose clinical study of CRD-4730 to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of CRD-4730 to participants with Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Catecholaminergic Polymorphic Ventricular Tachycardia
- What is being tested?
- CRD-4730
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 12 sitesin 6 countries
- Study dates
- 1 Dec 2025to Apr 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Each participant must meet all the following criteria to be enrolled in this study:
- The participant is male or female, ≥18 years of age and of legal adult age in accordance with local requirements.
- The participant has a confirmed CPVT diagnosis, based on genetic screening for a pathogenic ryanodine receptor (RYR2) mutation and a clinical phenotype consistent with CPVT at Screening. Previous CPVT genetic testing documented in medical history is acceptable if confirmed by the Investigator and documented in the study source records.
- The participant can perform an EST during which frequent premature ventricular contractions (PVCs; ≥10 per minute), ventricular bigeminy, or higher-grade VA (equivalent to a VA score ≥2) are identified by the Investigator.
- The participant has been on a stable dose of at least 1 antiarrhythmic medication (including beta blockers but not amiodarone) for 4 weeks prior to Screening, unless the participant has been unable to tolerate antiarrhythmic therapy previously.
- Adheres to all contraceptive criteria.
Who cannot join
- Participants meeting any of the following criteria will be excluded from the study:
- The participant has clinically significant structural heart disease, diagnosis of heart failure, or clinically significant coronary artery disease.
- The participant has a clinically significant abnormal ECG not explained by the diagnosis of CPVT at Screening or clinically significant abnormal intervals, such as prolonged QT.
- The participant has a history of a myocardial infarction, cerebrovascular accident, or transient ischemic attack within 3 months of Screening.
- The participant undergoes implantable cardioverter-defibrillator (ICD) implantation or has sympathetic nerve denervation within 3 months of Screening.
- The participant has an anticipated change in exercise regimen or new exercise program during the course of the study.
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- The participant has a history of malignancy within the past 5 years at Screening, with the exception of successfully treated basal cell carcinoma or nonmetastatic squamous cell carcinoma of the skin or cervical carcinoma in situ. Prior exposure to chest radiation for any malignancy is exclusionary.
- The participant has abnormal blood pressure, defined as supine symptomatic hypotension, systolic blood pressure >150 mm Hg or diastolic blood pressure >90 mm Hg, or symptomatic bradycardia or a heart rate >100 bpm at Screening and/or on Day 1. Blood pressure and pulse should be measured after the participant has been in the seated position after 5 minutes of rest.
- The participant has hepatic impairment defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 × (upper limit of normal [ULN]) and/or total bilirubin >1.5 × ULN at Screening (unless secondary to confirmed Gilbert syndrome).
- The participant has acute or chronic hepatitis B (HBV; defined as hepatitis B surface antigen [HBsAg] reactive), acute or chronic hepatitis C virus (HCV; defined as detection of HCV antibody and RNA [qualitative]), or human immunodeficiency virus (HIV) infection.
- The female participant is pregnant, lactating/breastfeeding, or has plans to become pregnant during the study or within 3 months following the last study drug administration.
- The participant has taken any antiarrhythmic drug in addition to their stable, chronic regimen unless it has been at least 5 half-lives since administration at the time of Screening.
Trial locations and contacts
12 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
12 sites in 6 countries
United States5 sites, 5 recruiting
- Recruiting
Cardurion Investigative Site
Houston, Texas, 77030
- Recruiting
Cardurion Investigative Site
Madison, Wisconsin, 53792
- Recruiting
Cardurion Investigative Site
Morrisville, North Carolina, 27560
- Recruiting
Cardurion Investigative Site
Salt Lake City, Utah, 84113
- Recruiting
Cardurion Investigative Site
San Francisco, California, 94143
France3 sites, 3 recruiting
- Recruiting
Cardurion Investigative Site
Bron, 69677
- Recruiting
Cardurion Investigative Site
Paris, 75018
- Recruiting
Cardurion Investigative Site
Saint-Herblain, 44800
Canada1 site, 1 recruiting
- Recruiting
Cardurion Investigative Site
Vancouver, British Columbia, V6Z 1Y6
Italy1 site, 1 recruiting
- Recruiting
Cardurion Investigative Site
Pavia, Pavia, 27100
Netherlands1 site, 1 recruiting
- Recruiting
Cardurion Investigative Site
Amsterdam, North Holland, 1105 AZ
Spain1 site, 1 recruiting
- Recruiting
Cardurion Investigative Site
Esplugues de Llobregat, Barcelona, 08950
About this study
Official title: A Phase 2, Double-Blind, Repeat-Dose, Placebo-Controlled Crossover Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CRD-4730 In Participants With Catecholaminergic Polymorphic Ventricular Tachycardia
This is a Phase 2, multicenter, double-blind, sponsor blinded, placebo-controlled, repeat-dose clinical study of CRD-4730 to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of CRD-4730 to participants with Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT). Participants with CPVT will complete a 3-period, randomized 3-sequence study. Each participant will be randomized to one of the 3 sequences in which they will receive 2 different doses of CRD-4730 and 1 dose of matching placebo.
- Being tested
- CRD-4730, Placebo
- Keywords
- CaMKII, CPVT, Ventricular Tachycardia, CRD-4730, Cardiovascular, Arrhythmia, Catecholaminergic Polymorphic Ventricular Tachycardia, CaM kinase II, Calmodulin-dependent protein kinase II
- Medical subject headings
- Polymorphic Catecholaminergic Ventricular Tachycardia, Tachycardia, Ventricular, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRD-4730Drug
Oral CRD-4730 in tablet form
PlaceboDrug
Placebo to match CRD-4730 in tablet form
| Study group | Role | What they receive |
|---|---|---|
| Dose 1 | Experimental | CRD-4730 Dose 1 Tablet Receives: Drug: CRD-4730 |
| Dose 2 | Experimental | CRD 4730 Dose 2 Tablet Receives: Drug: CRD-4730 |
| Dose 3 | Placebo comparator | Placebo tablet to match CRD-4730 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measures
The number and severity of treatment-emergent adverse events (TEAEs) related to study drug treatment
Measured: Baseline to Day 101
Secondary outcomes (2)
Secondary Outcome Measure
Change in VA score during EST from baseline to Day 15, from baseline to Day 44, and from baseline to Day 73
Measured: Baseline to Day 15; Baseline to Day 44; Baseline to Day 73
Secondary Outcome Measures
Plasma concentrations of CRD-4730 over time for each treatment period
Measured: Baseline to Day 15; Baseline to Day 44; Baseline to Day 73
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start1 Dec 2025
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Catecholaminergic Polymorphic Ventricular TachycardiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 3-period randomized 3-sequence study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cardurion Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06658899
- Sponsor's protocol ID
- CRD-4730-202
- Acronym
- CPVT
- Status last verified
- Jul 2026
- First submitted
- 23 Oct 2024
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Takagahara, Shuichi, et al. "Novel, Potent, and Highly Selective Calcium/Calmodulin-Dependent Protein Kinase II (CaMKII) Inhibitors Reduce Substrate Phosphorylation in Rat Hearts and Prolong Survival in a Mouse Model of Severe Heart Failure." Circulation 148.Suppl_1 (2023): A12726-A12726.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Double-Blind, Repeat-Dose, Placebo-Controlled Crossover Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CRD-4730 In Participants With Catecholaminergic Polymorphic Ventricular Tachycardia
- ClinicalTrials.gov ID
- NCT06658899
- Acronym / sponsor ID
- CPVT / CRD-4730-202
- Keywords
- CaMKII, CPVT, Ventricular Tachycardia, CRD-4730, Cardiovascular, Arrhythmia, Catecholaminergic Polymorphic Ventricular Tachycardia, CaM kinase II
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Cardurion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 26 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 2, multicenter, double-blind, sponsor blinded, placebo-controlled, repeat-dose clinical study of CRD-4730 to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of CRD-4730 to participants with Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT). Participants with CPVT will complete a 3-period, randomized 3-sequence study. Each participant will be randomized to one of the 3 sequences in which they will receive 2 different doses of CRD-4730 and 1 dose of matching placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 3-period randomized 3-sequence study
| Arm | Type | Receives |
|---|---|---|
| Dose 1 | Experimental | Drug: CRD-4730CRD-4730 Dose 1 Tablet |
| Dose 2 | Experimental | Drug: CRD-4730CRD 4730 Dose 2 Tablet |
| Dose 3 | Placebo comparator | Drug: PlaceboPlacebo tablet to match CRD-4730 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The participant is male or female, ≥18 years of age and of legal adult age in accordance with local requirements.
- The participant has a confirmed CPVT diagnosis, based on genetic screening for a pathogenic ryanodine receptor (RYR2) mutation and a clinical phenotype consistent with CPVT at Screening. Previous CPVT genetic testing documented in medical history is acceptable if confirmed by the Investigator and documented in the study source records.
- The participant can perform an EST during which frequent premature ventricular contractions (PVCs; ≥10 per minute), ventricular bigeminy, or higher-grade VA (equivalent to a VA score ≥2) are identified by the Investigator.
- The participant has been on a stable dose of at least 1 antiarrhythmic medication (including beta blockers but not amiodarone) for 4 weeks prior to Screening, unless the participant has been unable to tolerate antiarrhythmic therapy previously.
- Adheres to all contraceptive criteria.
Key exclusion criteria (12 listed)
- The participant has clinically significant structural heart disease, diagnosis of heart failure, or clinically significant coronary artery disease.
- The participant has a clinically significant abnormal ECG not explained by the diagnosis of CPVT at Screening or clinically significant abnormal intervals, such as prolonged QT.
- The participant has a history of a myocardial infarction, cerebrovascular accident, or transient ischemic attack within 3 months of Screening.
- The participant undergoes implantable cardioverter-defibrillator (ICD) implantation or has sympathetic nerve denervation within 3 months of Screening.
- The participant has an anticipated change in exercise regimen or new exercise program during the course of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CRD-4730Oral CRD-4730 in tablet form | Drug | Dose 1, Dose 2 |
| PlaceboPlacebo to match CRD-4730 in tablet form | Drug | Dose 3 |
Primary outcome
Primary Outcome Measures
Time frame: Baseline to Day 101
The number and severity of treatment-emergent adverse events (TEAEs) related to study drug treatment
2 secondary outcomes
Secondary Outcome Measure
Time frame: Baseline to Day 15; Baseline to Day 44; Baseline to Day 73
Secondary Outcome Measures
Time frame: Baseline to Day 15; Baseline to Day 44; Baseline to Day 73
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- BackgroundTakagahara, Shuichi, et al. "Novel, Potent, and Highly Selective Calcium/Calmodulin-Dependent Protein Kinase II (CaMKII) Inhibitors Reduce Substrate Phosphorylation in Rat Hearts and Prolong Survival in a Mouse Model of Severe Heart Failure." Circulation 148.Suppl_1 (2023): A12726-A12726.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
12 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CRD-4730 in people with Catecholaminergic Polymorphic Ventricular Tachycardia, run by Cardurion Pharmaceuticals, Inc. at 12 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, France, Canada, Italy, Netherlands and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cardurion (617-863-8088, infoCPVT@cardurion.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome Measures (time frame: Baseline to Day 101). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06658899, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.