Clinical Research Directory

Ademetionine in Obstructive Hypertrophic Cardiomyopathy

This study is a multicenter, double-blind, randomized controlled Phase 2 trial designed to evaluate the safety and efficacy of Ademetionine in patients with obstructive hypertrophic cardiomyopathy (oHCM). The study will recruit patients with oHCM who, under double-blind conditions, will be randomly assigned to either the Ademetionine group or the placebo group. Follow-up visits will be conducted every 4 weeks until 16 weeks from baseline. After 16 weeks, the study will evaluating the effect of Ademetionine on exercise capacity, heart failure symptoms, cardiac structure and function, and quality of life, as well as safety and tolerability of Ademetionine in this patient population.

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

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.

Mavacamten Post-marketing Surveillance in Patients With Obstructive Hypertrophic Cardiomyopathy in Japan

The purpose of this study is to assess the real-world effectiveness and safety of mavacamten in patients with obstructive hypertrophic cardiomyopathy (HCM) receiving mavacamten in Japan

A Study to Assess the Treatment of Obstructive Hypertrophic Cardiomyopathy (oHCM) With Mavacamten in the US

The purpose of this study is to evaluate the real-world safety and effectiveness of patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) initiated on mavacamten at certain high volume HCM centers in the US