NCT07439952Not yet recruiting
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
Source: ClinicalTrials.gov · Last updated 27 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 300 (estimated)
- First submitted
- 2 Feb 2026
- Start date
- 5 Feb 2026
- Primary completion date
- Jul 2029
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Hypertrophic cardiomyopathy
- NCT number
- NCT07439952
What you commit to
- Study type: Observational
- Planned participants: 300
- From 5 Feb 2026 to the primary completion date, Jul 2029
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Minors
- Adults under guardianship (legal guardianship and curatorship) or judicial protection
- Pregnant or breastfeeding women
Who the study is looking for
- \- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| APHP, Ambroise Paré Coordinator of this site? Confirm its status | Boulogne-Billancourt | France | Unknown status |
| APHP, Bicêtre hospital Coordinator of this site? Confirm its status | Le Kremlin-Bicêtre | France | Unknown status |
| APHP, La Pitié Salpetriere hospital Coordinator of this site? Confirm its status | Paris | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.