NL-OMON56426招募中3 期
A Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate Mavacamten in Adults with Symptomatic Non-obstructive Hypertrophic Cardiomyopathy - Mavacamten in non-obstructive HCM
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 31
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Participants must be at least 18 years old or local age of majority at the
- •time of signing the informed consent 2. Female participants must adhere to
- •highly effective contraceptive methods or have documented proof that they are
- •not of childbearing potential 3. No additional contraceptive measures are
- •required to be used for male participants 4. Diagnosis of HCM consistent with
- •current American College of Cardiology Foundation/American Heart Association
- •and European Society of Cardiology guidelines. 5. Peak LVOT pressure gradient <
- •30 mmHg at rest and < 50 mmHg with provocation (Valsalva maneuver and stress
- •echocardiography) 6. CPET: Documented oxygen saturation at rest >90% at
- •Screening. Able to perform an upright cardiopulmonary stress test (CPET) and
- •has a respiratory exchange ratio (RER) >= 1.0 at Screening per central reading.
- •If the RER is between 0.91 and 1.0, the participant may be enrolled if the
- •central CPET laboratory determines that peak exercise has been achieved.
- •Participants with subpeak performance may not be enrolled as described in the
- •CPET Laboratory Manual. 7. New York Heart Association (NYHA) Class II or III 8.
- •NT-proBNP>=200 pg/mL or BNP>=70 pg/mL 9. LVEF >=60 % as determined by the
- •echocardiography central laboratory 10. KCCQ-23 CSS Score <= 85 at screening
排除标准
- •Medical Conditions - Known infiltrative or storage disorder causing cardiac
- •hypertrophy that mimics nHCM such as Fabry disease, amyloidosis, or Noonan
- •syndrome with LV hypertrophy
- •Note: Investigators should not screen participants who have comprehensive Echo
- •features suggestive of amyloidosis, including
- •abnormal global longitudinal strain in the setting of an appropriate clinical
- •picture which could include low voltage on ECG and severely elevated NT-proBNP
- •- History of unexplained syncope within 6 months prior to screening - History
- •of sustained ventricular tachyarrhythmia (> 30 seconds) within 6 months prior
- •to Screening - Paroxysmal or persistent (non-permanent) AF detected at the time
- •of screening. Permanent AF is allowed if the participant is anticoagulated and
- •the investigator considers the heart rate adequately controlled - CV diseases
- •or treatments that in the opinion of the investigator increase the
- •unpredictability of or change the participants' clinical course. - Acute heart
- •failure from 4 weeks prior to screening up to randomization - Coronary artery
- •disease requiring intervention, including myocardial infarction (increase in
- •cardiac enzymes in combination with symptoms of ischemia or new ischemic ECG
- •changes), coronary artery bypass graft surgery, or other major CV surgery,
- •stroke, or transient ischemic attack in the past 90 days - Women who are
- •breastfeeding or pregnant. Prior/Concomitant Therapy - Any adjustments of
- •beta-blockers, verapamil, or diltiazem within 2 weeks prior to Screening and up
- •to the day of randomization - Concomitant use of strong inhibitors of
- •cytochrome P450 (CYP) 2C19 Note: Use should be discontinued for a minimum of 5
- •elimination half-lives prior to first dose of study intervention. Other
- •Exclusion Criteria - Any other serious condition that in the opinion of the
- •investigator could prevent participation in the study and follow-up, including
- •active infection with COVID-19 from 4 weeks prior to screening up to
- •randomization - Completed a study with an investigational device < 30 days
- •prior to screening or an investigational drug <5 half-lives prior to screening
- •- Participants who have completed a study with mavacamten or aficamten
- •--Enrolled in another study and receiving any investigational treatment (device
- •or drug) other than the study intervention given in this study
研究者
相似试验
招募中
1 期
A Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate Mavacamten in Adults with CardiomyopathyEUCTR2021-005329-26-NLMyokardia, Inc.420
招募中
3 期
Mavacamten in non-obstructive HCMsymptomatic non-obstructive hypertrophic cardiomyopathy (nHCM)JPRN-jRCT2051220175Aronson Ron34
进行中（未招募）
1 期
A Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate Mavacamten in Adults with CardiomyopathyEUCTR2021-005329-26-NOMyokardia, Inc.420
进行中（未招募）
1 期
A Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate Mavacamten in Adults with CardiomyopathySymptomatic Nonobstructive Hypertrophic CardiomyopathyMedDRA version: 20.0Level: PTClassification code 10049813Term: Non-obstructive cardiomyopathySystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 20.0Level: PTClassification code 10020871Term: Hypertrophic cardiomyopathySystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2021-005329-26-DEMyokardia, Inc.420
进行中（未招募）
1 期
A Study of Mavacamten in Adolescent Participants with Symptomatic Obstructive Hypertrophic CardiomyopathySymptomatic Obstructive Hypertrophic CardiomyopathyMedDRA version: 20.0Level: LLTClassification code: 10020876Term: Hypertrophic obstructive cardiomyopathy Class: 10010331CTIS2023-505650-17-00Bristol-Myers Squibb Services Unlimited Company40