2025-524722-17-00招募中4 期
Short and long-term Hemodynamic and Physiological Effects of Mavacamten in Obstructive Hypertrophic Cardiomyopathy
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- Region Skane
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in myocardial perfusion reserve (MPR) (averaged values across all hypertrophied myocardial segments without significant LGE) from baseline to 2 years after initiation of treatment.
研究概览
简要总结
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.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
CAMZYOS 10 mg hard capsules
Test
干预措施: CAMZYOS 10 mg hard capsules (Drug)
结局指标
主要结局
Change in myocardial perfusion reserve (MPR) (averaged values across all hypertrophied myocardial segments without significant LGE) from baseline to 2 years after initiation of treatment.
Change in myocardial perfusion reserve (MPR) (averaged values across all hypertrophied myocardial segments without significant LGE) from baseline to 2 years after initiation of treatment.
次要结局
- Change in MPR from BL to 12 weeks
- Change in MPR from BL to 1 year
- Changes in T1, T2 and extracellular volume (ECV) mapping from BL to 12 w, 1 year and 2 years
- Change in LGE extent from BL to 12 w, 1 year and 2 years
- Change in stroke work, ventricular efficiency, contractility, and arterial elastance assessed by P-V-loop-analysis from BL to 12 w, 1 year and 2 years
- Change in kinetic energy and regional pressure gradients assessed by 4D flow-analysis from BL to 12 w, 1 year and 2 years
- Changes in myocardial mass and left atrial volume assessed by standard CMR from BL to 12 w, 1 year and 2 years
研究者
Oscar Braun
Scientific
Region Skane
研究点 (2)
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