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Clinical Trials in France / NCT07439952
Starting soon Observational

Biological Collection for the Purpose of Exploring Genetic and Clinical-biological Factors Associated With Variability in Response to Mavacamten in the Treatment of Obstructive Hypertrophic Cardiomyopathy

NCT07439952 · tracked via the Priya Life Science France tracker
Sponsor
Assistance Publique - Hôpitaux de Paris
Phase
Observational
Started
2026-02-05
Last updated
2026-02-27

Condition(s) studied

Obstructive Hypertrophic Cardiomyopathy (oHCM)

Study summary

The European Medicines Agency has required pre-treatment genotyping of CYP2C19 to determine the initial and maximum dosage, in order to avoid overexposure to mavacamten associated with a decrease in ventricular ejection fraction below 50% in slow metabolisers of CYP2C19 (AUC multiplied by 3.4). The study is a requalification for the search for DNA samples obtained during treatment in order to genotype the genes of interest.The primary objective of the study is to estimate, for each of the CYP2C19 phenotypes of interest determined by genotyping (ultra-rapid, rapid, normal/extensive and intermediate metabolisers), the proportion of patients who are non-responders to mavacamten at each time point (D0, Week 4, Week 8, Week 12 and Week 24 in the treatment of HCM). This is a multicentre (3 centres which are hospitals of APHP) study aiming to include 300 patients with obstructive hypertrophic cardiomyopathy treated with Mavacamten who underwent or are undergoing CYP2C19 genotyping at the start of treatment. The inclusion period is 36 months and the follow-up period is 6 months. The total duration of the study is 42 months.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * \- Patients aged ≥18 years * Diagnosis of obstructive hypertrophic cardiomyopathy (OHCM), based on the guidelines of the European Society of Cardiology (Arbelo et al. 2023), with unexplained left ventricular hypertrophy and a maximum LVOT gradient ≥ 50 mmHg at rest, or after Valsalva manoeuvre or exercise at the time of diagnosis, and an LVOT gradient with Valsalva manoeuvre ≥ 30 mmHg at selection * With cardiac symptoms defined as NYHA class II/III, persistent despite background treatment (beta-blockers or calcium channel blockers) * LVEF ≥55% at the start of treatment with mavacamten * Initiation of treatment with mavacamten or patient already receiving treatment * Prescription of pre-treatment CYP2C19 genotyping performed * Consent to participate signed by the patient * Beneficiary of health insurance Exclusion Criteria: * Minors * Adults under guardianship (legal guardianship and curatorship) or judicial protection * Pregnant or breastfeeding women

Primary outcome measure(s)

  • Response rate to Mavacamten treatment — Day 0, Week4, Week 8, Week 12, Week 24
    Proportion of patients responding to mavacamten (LVEF \>55% and LVOT gradient at Valsalva \<30 mL/min) according to different CYP2C19 and CYP3A phenotypic groups at 12 and 24 weeks, evaluated by echocardiography

Trial sites (3)

FacilityCityRegionStatus
APHP, Ambroise Paré Boulogne-Billancourt France
APHP, Bicêtre hospital Le Kremlin-Bicêtre France
APHP, La Pitié Salpetriere hospital Paris France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07439952 on ClinicalTrials.gov ↗ ← All trials in France