NCT06555237 MEK Inhibitors for the Treatment of Hypertrophic Cardiomyopathy in Patients With RASopathies
| NCT ID | NCT06555237 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Medical University of Warsaw |
| Condition | Cardiomegaly |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-08-01 |
| Primary Completion | 2026-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 40 participants in total. It began in 2024-08-01 with a primary completion date of 2026-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this study is to evaluate the effectiveness of trametinib treatment in patients with Hyperthropic cardiomyopathy and a genetic mutation in the RAS/MAPK pathway.
Eligibility Criteria
Inclusion Criteria: * patient with diagnosed RASopathy * patient with diagnosed hypertrophic cardiomyopathy * signed innform consent Exclusion Criteria: * contraindications to treatment with propranolol (drug hypersensitivity, atrioventricular block, severe bradycardia) disopyramide (drug hypersensitivity, WPW syndrome, atrioventricular block, QT prolongation) trametinib (drug hypersensitivity) * lack of consent of the child's guardians to participate in the study
Contact & Investigator
MAciej Kołodziej, MD
PRINCIPAL INVESTIGATOR
Medical University of Warsaw
Frequently Asked Questions
Who can join the NCT06555237 clinical trial?
This trial is open to participants of all sexes, aged 1 Day or older, up to 18 Years, studying Cardiomegaly. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06555237 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06555237 currently recruiting?
Yes, NCT06555237 is actively recruiting participants. Contact the research team at maciej.kolodziej@wum.edu.pl for enrollment information.
Where is the NCT06555237 trial being conducted?
This trial is being conducted at Warsaw, Poland.
Who is sponsoring the NCT06555237 clinical trial?
NCT06555237 is sponsored by Medical University of Warsaw. The principal investigator is MAciej Kołodziej, MD at Medical University of Warsaw. The trial plans to enroll 40 participants.