EUCTR2015-002283-16-DK进行中（未招募）1 期
Phase II randomized, placebo-controlled, double blind clinical trial of valsartan for attenuating disease evolution in early sarcomeric HCM - VANISH
ational Heart, Lung, and Blood Institute / National Institutes of Health0 个研究点目标入组 150 人开始时间: 2015年12月16日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •5.2 Inclusion Criteria
- •1.All subjects must have a Pathogenic or Likely Pathogenic HCM Sarcomere Mutation
- •a.The following categories of mutations are considered acceptable for subjects who have previously undergone clinical genetic testing. If results are ambiguous or testing was performed at a lab other than those listed below, they will be reviewed by the Clinical Coordinating Center to determine eligibility.
- •i.Laboratory for Molecular Medicine
- •1.Pathogenic
- •2.Likely Pathogenic
- •ii.Transgenomics/ PGXHealth
- •1.Disease causing
- •2.Variant, likely disease-causing
- •3.Published, disease-causing mutation
- •4.Novel, likely disease-causing, mutation
- •iv.Correlagen
- •1.Associated
- •2.Probably Associated
- •2.Group 1 Cohort
- •a.LV wall thickness =12 mm and =25 mm or z score =3 and =18 as determined by rapid assessment by the echocardiographic core laboratory
- •b.NYHA functional class I or II; no perceived or only slight limitations in physical activities
- •c.No resting or provokable LV obstruction (peak gradient = 30 mmHg) on clinically-obtained ETT-echo within the past 24 months or transthoracic echo with Valsalva maneuver within the past 12 months
- •d. Age 8-45 years
- •3.Group 2 Cohort (G+/LVH-)
- •a.LV Wall Thickness <12 mm and z score <3, as determined by rapid assessment by the echocardiographic core laboratory
- •b.Age 10-25 years
- •c.E’ z score = -1.5 OR ECG abnormalities other than NSSTW changes (Q waves, T wave inversion, repolarization changes) OR LV wall thickness z-score 1.5-2.9 combined with LV thickness to dimension ratio =0.19 (as determined by rapid assessment by the echocardiographic core laboratory)
- •4.Able to attend follow-up appointments, complete all study assessments, and provide written informed consent
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 75
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 75
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •5.3Subject Exclusion Criteria
- •1.Contraindication to ARB administration, including impaired renal function, hyperkalemia (serum K>5.0 mmol/L), prior history of angioedema
- •2.Medical conditions associated with increased collagen turnover that may confound interpretation of biomarkers of collagen synthesis (liver, pulmonary or renal fibrosis, inflammatory states, cancer, trauma or surgery within 6 months of enrollment)
- •3.Concomitant use of Spironolactone, Lithium, Aliskren, ARB or ACE-inhibitors.. If these drugs are in active use but not necessary for medical care, they may be discontinued and baseline studies can be performed after a 2-week washout period.
- •4.Pregnant or breastfeeding females
- •5.Females of childbearing potential with no effective contraceptive method (including abstinence)
- •6.Uncontrolled systemic HTN [persistent SBP>160 and/or DBP>90 in adult or equivalent in children (e.g. SBP>99th or DBP>95th percentile for sex, age, and height centile based on the American Academy of Pediatrics normal values)
- •7.Obstructive physiology, defined by resting, Valsalva-provoked or exercise-induced gradient >30mmHg within the past 24 months
- •8.Prior septal myectomy or alcohol septal ablation
- •9.Known, suspected, or symptomatic coronary artery disease or evidence of prior myocardial infarction based on symptoms or cardiac imaging
- •10.More than mild valvular heart disease or clinically significant congenital heart disease. Allowable conditions include bicuspid aortic valve without clinically significant stenosis or regurgitation; spontaneously closed ventricular septal defects; patent foramen ovale, small (= 2 mm) restrictive ventricular septal defects with normal ventricular size, and other minor defects that are considered allowable after [review and consensus by participating pediatric cardiologists, overall study PI and] adjudication by the echocardiographic core laboratory.
- •11.LVEF <55%
- •12.Concomitant medical conditions that would preclude performance of or confound interpretation of echocardiography, exercise testing, or CMR (e.g., renal insufficiency, lung disease, orthopedic/rheumatologic conditions, atrial fibrillation)
- •13.Secondary prevention implantable cardioverter-defibrillator device (ICD; primary prevention ICDs without a history of appropriate therapy, including shock or ATP, are allowable).
- •14.Prior treatment or hospitalization for symptomatic heart failure
- •15.Participation in a clinical trial (except observational studies) involving investigational medications within the previous 30 days.
研究者
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