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Tests treatment safety and results for Catecholaminergic Polymorphic Ventricular Tachycardia
Official title Safety, Tolerability, and Exploratory Efficacy of AGP100 in Patients With Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)
ClinicalTrials.gov ID: NCT07263139
What this study is testing
What is AGP100?
AGP100 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for catecholaminergic polymorphic ventricular tachycardia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This trial is conducted in patients with an inherited heart rhythm disorder called catecholaminergic polymorphic ventricular tachycardia (CPVT). This condition causes the heart to beat dangerously fast during situations of physical or emotional stress.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Signed informed consent prior to any study-related procedures
- Male or female, aged between 18 and 75 years (inclusive)
- Clinical diagnosis of CPVT based on proven RYR2 mutation AND reproducible premature ventricular contraction with exercise or polymorphic or...
- Able and willing to undergo exercise testing (bicycle test) AND exhibits exercise-induced ventricular ectopic beats at Screening (at least 1 point on...
- On stable, maximum tolerated, dose of non-selective β-blocker for at least 4 weeks before Visit 1. The dosage and choice of β-blocker are to be...
You likely can't join if
- are:
- Diagnosis of structural heart disease, including coronary artery disease or heart failure with reduced ejection fraction (left ventricular ejection...
- Participants who have had arrhythmias causing hemodynamic instability at previous exercise tests (performed while on the current standard of care...
- Participants having a sustained VT (VA score of 5) during the exercise tests performed as part of the screening activities
- Participation in another clinical study with an investigational product or device within 60 days of 5 half-lives prior to Baseline (whichever is...
- Medical history of severe anaphylactic reactions to any component(s) of the IMP
See the full eligibility criteria
- Signed informed consent prior to any study-related procedures
- Male or female, aged between 18 and 75 years (inclusive)
- Clinical diagnosis of CPVT based on proven RYR2 mutation AND reproducible premature ventricular contraction with exercise or polymorphic or bidirectional ventricular tachycardia with exercise
- Able and willing to undergo exercise testing (bicycle test) AND exhibits exercise-induced ventricular ectopic beats at Screening (at least 1 point on the VA scale)
- On stable, maximum tolerated, dose of non-selective β-blocker for at least 4 weeks before Visit 1. The dosage and choice of β-blocker are to be determined by the patients' physician(s) before entry into the study and...
- Clinical laboratory evaluations including clinical chemistry, haematology, urinalysis, thyroid function (including thyroid stimulating hormone, triiodothyronine, thyroxine, and free T4) and coagulation testing...
- Willing to refrain from strenuous or new exercise for 24 hours before each study visit
- Women of childbearing potential (WOCBP) agree to implement accepted and highly effective means of contraception from study entry until at least 33 days after study drug discontinuation (as per the Clinical Trials...
- are:
- Diagnosis of structural heart disease, including coronary artery disease or heart failure with reduced ejection fraction (left ventricular ejection fraction \<45%)
- Participants who have had arrhythmias causing hemodynamic instability at previous exercise tests (performed while on the current standard of care treatment)
- Participants having a sustained VT (VA score of 5) during the exercise tests performed as part of the screening activities
- Participation in another clinical study with an investigational product or device within 60 days of 5 half-lives prior to Baseline (whichever is longer)
- Medical history of severe anaphylactic reactions to any component(s) of the IMP
- Sensitivity to any of the study treatments, or components thereof, or any drug or other allergy that, in the opinion of the Investigator precludes participation in the study
- Hypersensitivity or contraindication to PDE2 inhibitor drugs
- Use of PDE3, PDE4, or PDE5 inhibitor drugs.
- Participants taking any antiarrhythmic drug(s) except flecainide and non-selective β-blockers
- Significant hypertension (defined as systolic blood pressure of \>160 mmHg and/or diastolic blood pressure of \>95 mmHg). If the blood pressure results are out of range at Screening, the measurements can be repeated on...
- Prolonged PR and/or QTc interval at Screening, defined as PR \>240 ms or QTc \>480 ms
The study team makes the final eligibility decision.
Where it's taking place
- Oslo, Norway
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Oslo, Norway. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.