BridgeMD
Short and long-term Hemodynamic and Physiological Effects of Mavacamten in Obstructive Hypertrophic Cardiomyopathy
EU CTIS ID: 2025-524722-17-00
What this study is testing
to investigate acute, sub-acute and chronic hemodynamic and physiological effects of treatment with mavacamten in patients with oHCM using state-of-the art cardiovascular magnetic resonance (CMR) imaging.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- The subject has given their written consent to participate in the trial.
- Age ≥ 18 years
- Diagnosis of oHCM with unexplained LV hypertrophy with nondilated ventricular chambers in the absence of other cardiac (eg, hypertension, aortic stenosis) or systemic disease and with maximal LV wall thickness ≥15 mm
- Eligible for on-label mavacamten therapy per Swedish prescribing information.
- Left ventricular outflow tract (LVOT) ≥ 50 mmHg at rest, during Valsalva or post-exercise.
- Left ventricular ejection fraction ≥ 55%
You likely can't join if
- Presence or planned implantation of electronic cardiac devices such as ICD or pacemaker
- Reduced kidney function with estimated GFR <30 ml/min/1.73m2
- Severe impairment of liver function (Child-Pugh class C) or if there is an alanine aminotransferase or aspartate aminotransferase result, the value must be <3 × the upper limit of the laboratory reference range
- Unable to comply with the study requirements
- Unable to perform CMR exams
- Body mass index ≥ 40kg/m2
See the full eligibility criteria
Who can join
- The subject has given their written consent to participate in the trial.
- Age ≥ 18 years
- Diagnosis of oHCM with unexplained LV hypertrophy with nondilated ventricular chambers in the absence of other cardiac (eg, hypertension, aortic stenosis) or systemic disease and with maximal LV wall thickness ≥15 mm
- Eligible for on-label mavacamten therapy per Swedish prescribing information.
- Left ventricular outflow tract (LVOT) ≥ 50 mmHg at rest, during Valsalva or post-exercise.
- Left ventricular ejection fraction ≥ 55%
- New York Heart Association (NYHA) class II or III symptoms.
- Participants who are capable of becoming pregnant must not be pregnant or lactating and, if sexually active, must use effective birth control methods (see section 7.4) from the Screening visit through 6 months after the last dose of mavacamten.
What rules you out
- Presence or planned implantation of electronic cardiac devices such as ICD or pacemaker
- Reduced kidney function with estimated GFR <30 ml/min/1.73m2
- Severe impairment of liver function (Child-Pugh class C) or if there is an alanine aminotransferase or aspartate aminotransferase result, the value must be <3 × the upper limit of the laboratory reference range
- Unable to comply with the study requirements
- Unable to perform CMR exams
- Body mass index ≥ 40kg/m2
- Participation or recent participation in a clinical trial with an investigational medicinal product within 30 days.
- Previous participation in this trial
- Known or suspected allergies against any product included in the trial
- Pregnancy (positive p-hCG test at screening), breastfeeding, or planned pregnancy
- Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of participation in the trial
- History of or planned septal reduction therapy (surgical myectomy or percutaneous alcohol ablation) during trial period
- Treatment or disease which, according to the investigator, can affect treatment or trial results
- Known infiltrative or storage disorder causing cardiac hypertrophy that mimics oHCM, such as Fabry disease, amyloidosis, or Noonan syndrome with LV hypertrophy
- Has paroxysmal, intermittent atrial fibrillation with atrial fibrillation present per the investigator’s evaluation of the participant’s ECG at the time of Screening
- Has permanent atrial fibrillation
- Current treatment (within 14 days prior to screening) or planned treatment during the study with: (a) a strong CYP3A4 inhibitor in participants with poor or unknown CYP2C19 metaboliser phenotype; (b) the simultaneous combination of a strong CYP2C19 inhibitor and a strong CYP3A4 inhibitor; (c) strong inducers of both CYP2C19 and CYP3A4 (e.g. rifampicin, carbamazepine, phenytoin, efavirenz, St. John's Wort); or (d) omeprazole or esomeprazole.
- Has documented obstructive coronary artery disease (>70% stenosis in one or more epicardial coronary arteries) or history of myocardial infarction
- Has known moderate or severe (as per investigator’s judgment) aortic valve stenosis at Screening
- Has any acute or serious comorbid condition (eg, major infection or hematologic, renal, metabolic, gastrointestinal, or endocrine dysfunction) that, in the judgment of the investigator, could lead to premature termination of study participation or interfere with the measurement or interpretation of the efficacy and safety assessments in the study
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.