New pill could tame deadly heart flutters during exercise
NCT ID NCT07263139
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a new oral drug called AGP100 in people with a rare inherited heart condition (CPVT) that can cause dangerously fast heartbeats during stress or exercise. Ten adults aged 18-75 will take three different doses of AGP100 over six weeks while continuing their usual heart medications. Researchers will check if the drug is safe and helps maintain a normal heart rhythm during exercise.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- AGP100 (oral capsule)
- What this could lead to
- If successful, AGP100 could offer a new treatment option to better control dangerous heart rhythms in people with CPVT, potentially improving their ability to exercise safely.
- What could go wrong
- This is a small, early-phase trial with only 10 participants, so results may not apply to everyone. The drug may cause side effects or fail to improve heart rhythm control.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Signed informed consent prior to any study-related procedures 2. Male or female, aged between 18 and 75 years (inclusive) 3. Clinical diagnosis of CPVT based on proven RYR2 mutation AND reproducible premature ventricular contraction with exercise or polymorphic or bidirectional ventricular tachycardia with exercise 4. 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) 5. 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 must remain unchanged throughout the conduct of the study. Participants taking a stable dose of flecainide for at least 4 weeks, in addition to β-blocker, are also eligible. 6. Clinical laboratory evaluations including clinical chemistry, haematology, urinalysis, thyroid function (including thyroid stimulating hormone, triiodothyronine, thyroxine, and free T4) and coagulation testing (activated partial thromboplastin time, and international normalized ratio) within the reference range, unless deemed not clinically significant by the Investigator 7. Willing to refrain from strenuous or new exercise for 24 hours before each study visit 8. 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 Facilitation and Coordination Group guidelines). The main exclusion criteria are: 1. Diagnosis of structural heart disease, including coronary artery disease or heart failure with reduced ejection fraction (left ventricular ejection fraction \<45%) 2. Participants who have had arrhythmias causing hemodynamic instability at previous exercise tests (performed while on the current standard of care treatment) 3. Participants having a sustained VT (VA score of 5) during the exercise tests performed as part of the screening activities 4. Participation in another clinical study with an investigational product or device within 60 days of 5 half-lives prior to Baseline (whichever is longer) 5. Medical history of severe anaphylactic reactions to any component(s) of the IMP 6. 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 7. Hypersensitivity or contraindication to PDE2 inhibitor drugs 8. Use of PDE3, PDE4, or PDE5 inhibitor drugs. 9. Participants taking any antiarrhythmic drug(s) except flecainide and non-selective β-blockers 10. 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 the same day more than once, or at another convenient visit 11. Prolonged PR and/or QTc interval at Screening, defined as PR \>240 ms or QTc \>480 ms
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Department of Cardiology, Oslo University Hospital
RECRUITINGOslo, Norway
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- Brazil launches massive heart gene hunt to unlock hereditary mysteries
- New drug aims to tame rare, Exercise-Triggered heart condition
- New heart test could predict sudden cardiac death risk