CRD-4730 for Arrhythmia

(CPVT Trial)

Recruiting at 2 trial locations

Overseen By Jason Homsy, MD, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Cardurion Pharmaceuticals, Inc.

Must be taking: Antiarrhythmics, Beta blockers

Must not be taking: Amiodarone

Disqualifiers: Heart disease, Heart failure, Malignancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 15 weeks

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new treatment called CRD-4730, a potential drug for Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT), which can cause irregular heartbeats. Researchers seek to determine the safety of CRD-4730 and its effects on the body compared to a placebo (a pill with no active drug). Participants will receive varying doses of the treatment and a placebo during the study. Eligible participants must have CPVT confirmed by genetic testing, experience frequent irregular heartbeats during exercise, and have been on stable heart medication for at least four weeks. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial requires that you have been on a stable dose of at least one antiarrhythmic medication (like beta blockers, but not amiodarone) for 4 weeks before starting. You should not take any additional antiarrhythmic drugs unless it's been at least 5 half-lives since you last took them.

Is there any evidence suggesting that CRD-4730 is likely to be safe for humans?

Research shows that CRD-4730 is being tested for safety and tolerance in people with Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT), a condition causing irregular heartbeats. In earlier studies, most participants tolerated CRD-4730 well, experiencing only mild side effects. These studies have helped clarify how the drug works in the body and any potential risks.

This is a Phase 2 trial, indicating that earlier research likely found CRD-4730 safe enough for broader testing. However, more information is needed for confirmation. Prospective participants should know that while some side effects might occur, the trial aims to ensure the treatment's safety before further testing. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for arrhythmia?

Researchers are excited about CRD-4730 for arrhythmia because it potentially offers a new way to manage this condition. While most current treatments focus on controlling the heart's electrical signals or slowing the heart rate, CRD-4730 may work by targeting a different pathway, possibly offering benefits for patients who don't respond well to standard therapies. Additionally, CRD-4730 is being tested in multiple doses, which could help find the most effective and safest amount for patients. This fresh approach could lead to better control of arrhythmia symptoms and improve overall heart health.

What evidence suggests that CRD-4730 might be an effective treatment for CPVT?

Research has shown that CRD-4730 might help treat Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT), a condition causing irregular heartbeats. Early results suggest that CRD-4730 manages these irregular beats by addressing the root causes. The treatment improves how heart cells handle calcium, crucial for maintaining a normal heartbeat. This method is promising because calcium management is a major issue in heart rhythm problems. While more studies are underway, initial findings offer hope for people with CPVT. Participants in this trial will receive different doses of CRD-4730 or a placebo to further evaluate its effectiveness. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for people with a heart rhythm disorder called CPVT, confirmed by genetic testing and clinical symptoms. Participants must have specific types of irregular heartbeats during an exercise stress test and be on a stable dose of antiarrhythmic medication (except amiodarone) or unable to tolerate such therapy. They also need to follow contraceptive guidelines.

Inclusion Criteria

I follow all birth control requirements.

I have been diagnosed with CPVT due to a specific genetic mutation.

I have frequent irregular heartbeats during exercise tests.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 2 different doses of CRD-4730 and 1 dose of matching placebo in a 3-period, randomized 3-sequence study

15 weeks

Multiple visits across 3 periods

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CRD-4730

Trial Overview

The study tests CRD-4730's safety, how the body processes it, and its effects in patients with CPVT. It's a double-blind trial where participants get two doses of CRD-4730 and one placebo at random across three periods without knowing which they're receiving.

How Is the Trial Designed?

Group I: Dose 2 Experimental Treatment 1 Intervention

CRD 4730 Dose 2 Tablet

Group II: Dose 1 Experimental Treatment 1 Intervention

CRD-4730 Dose 1 Tablet

Group III: Dose 3 Placebo Group 1 Intervention

Placebo tablet to match CRD-4730

Who Is Running the Clinical Trial?

Cardurion Pharmaceuticals, Inc.

Lead Sponsor

Trials

6

Recruited

740+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06005428

Study Details | NCT06005428 | Effectiveness of CRD-4730 ...

This is a Phase 2, multicenter, double-blind, sponsor unblinded, placebo-controlled, single-dose clinical study of CRD-4730 to evaluate the safety, ...

2.

clinicaltrials.eu

clinicaltrials.eu/inn/crd-4730/

Crd-4730 – Application in Therapy and Current Clinical ...

The primary outcomes include monitoring for treatment-emergent adverse events, changes in laboratory assessments, vital signs, and ECG measurements. Secondary ...

3.

ahajournals.org

ahajournals.org/doi/abs/10.1161/CIRCULATIONAHA.125.075150

Targeting Calcium Regulation for Heart Failure and ...

In this review, we critically assess the current state of research on Ca2+-handling proteins and their role in causing heart failure and ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06658899

NCT06658899 | A Phase 2 Study of CRD-4730 in CPVT

This is a Phase 2, multicenter, double-blind, sponsor blinded, placebo-controlled, repeat-dose clinical study of CRD-4730 to evaluate the safety, tolerability, ...

5.

withpower.com

withpower.com/trial/phase-2-cpvt1-8-2023-9176c?condition=Heart+Disease&overallStatus=Recruiting&hasNoPlacebo=false

CRD-4730 for Catecholaminergic Polymorphic Ventricular ...

Early results suggest that CRD-4730 may help manage these irregular heartbeats by addressing the root causes more directly. However, ongoing studies must ...

6.

clinicaltrials.eu

clinicaltrials.eu/trial/study-on-the-safety-of-crd-4730-for-patients-with-catecholaminergic-polymorphic-ventricular-tachycardia-cpvt/

Study on the Safety of CRD-4730 for Patients with ...

This clinical trial investigates the safety and tolerability of CRD-4730 as a potential treatment for Catecholaminergic Polymorphic Ventricular Tachycardia ...

7.

patlynk.com

patlynk.com/trial/NCT06658899

CRD-4730 for Catecholaminergic Polymorphic Ventricular ...

CPVT can cause irregular heartbeats, which can be dangerous. The study aims to assess how safe and well-tolerated CRD-4730 is, as well as how it behaves in the ...