2024-520086-31-00招募中4 期
HYDrochlorothiazidE compared to valsartan to treat arterial hypertension in patients with Hypertrophic obstructive CardioMyopathy – the multicenter, randomized, double-blind, controlled, crossover HYDE-HCM Trial
Medical University Of Graz5 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年12月29日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 5
- 主要终点
- Difference in absolute change of peak LVOT gradient at rest from before to after the treatment period between the two interventions
研究概览
简要总结
To assess if in patients with HOCM and arterial hypertension, low dose HCT increases peak LVOT gradient at rest to a significantly lesser extent than valsartan
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
- •Diagnosis of HCM consistent with the current Guidelines of the European Society of Cardiology and American College of Cardiology Foundation/American Heart Association: presence of increased left ventricular wall thickness (≥15mm or ≥13mm with positive family history of HCM) in any myocardial segment that is not explained solely by loading conditions
- •SAM-associated LVOTO, defined as peak LVOT pressure gradient ≥ 30mmHg at rest assessed 30 to 60 minutes after standardized meal intake
- •Fasting office blood pressure ≥ 135/85 mmHg (either systolic or diastolic BP increased), measured as standardized office blood pressure after at least six hours of fasting
- •Treatment with cardioselective betablocker in maximally tolerated dose or intolerance/contraindication to betablocker
- •Age ≥ 18 years
- •Female participants are eligible to participate if they are not pregnant or breastfeeding, and at least 1 of the following conditions applies: o is not a women of childbearing potential (WOCBP) or o is a WOCBP and using a contraceptive method that is highly effective (failure rate <1% per year) during the intervention period
- •No additional contraceptive measures are required to be used for male participants
- •Willingness and ability to provide signed written informed consent form (ICF) in accordance with regulatory, local, and institutional guidelines.
排除标准
- •Known infiltrative or storage disorder causing cardiac hypertrophy that mimics HCM, such as amyloidosis, Fabry disease, Noonan syndrome, or other HCM-phenocopies.
- •Initiation or change in myosin-inhibitor therapy 52 weeks prior to randomization or planned initiation during the active study period
- •Known allergy to HCT or valsartan or their constituents, or to medications with a similar chemical structure
- •Any other contraindication for treatment with either HCT or valsartan, including: • eGFR <30mL/min and/or serum creatinine >1.8mg/100mL • acute glomerulonephritis • severe hepatic zirrhosis or failure, hepatic precoma/coma • systolic blood pressure <90mmHg • heart rate <50bpm • sodium <130mmol/L • total calcium >2.65mmol/L • gout • second and third trimester of pregnancy
- •Women who are breastfeeding or pregnant
- •Any other serious condition that in the opinion of the investigator could prevent participation in the study.
- •Completed a study with an investigational device or drug <30 days or 5 half-lives to screening.
- •Enrolled in another study and receiving any investigational treatment (device or drug).
- •Current treatment or treatment within 2 weeks prior to randomization with either a thiazide diuretic or an angiotensin receptor blocker
- •Change in antihypertensive therapy within 2 weeks prior to randomization and up to the day of randomization.
- •Concomitant use of Aliskiren in patients with diabetes mellitus or renal disease (estimated glomerular filtration rate [eGFR] <60mL/min).
- •Invasive septal reduction therapy (surgical myectomy or percutaneous alcohol septal ablation) within 6 months prior to screening or planned invasive septal reduction therapy during the study.
结局指标
主要结局
Difference in absolute change of peak LVOT gradient at rest from before to after the treatment period between the two interventions
Difference in absolute change of peak LVOT gradient at rest from before to after the treatment period between the two interventions
次要结局
- Difference of absolute changes between the two intervention groups of Peak LVOT gradient after Valsalva-Maneuver
- Difference of absolute changes between the two intervention groups of left ventricular systolic pressure calculated from brachial blood pressure and LVOT gradient
- Difference of absolute changes between the two intervention groups of Kansas City Cardiomyopathy Questionnaire (KCCQ-23 Score)
- Difference of absolute changes between the two intervention groups of EQ5D5L score
- Difference of absolute changes between the two intervention groups of NT-proBNP
- Difference of absolute changes between the two intervention groups of High-sensitive Troponin T/I
- Difference of absolute changes between the two intervention groups of Interleukin-6
- Difference of absolute changes between the two intervention groups of pVO2 during CPET (CPET sub-study)
- Difference of absolute changes between the two intervention groups of mean systolic postprandial office blood pressure
- Difference of absolute changes between the two intervention groups of mean diastolic postprandial office blood pressure
- Number of serious adverse events (SAEs)
- Difference of absolute changes between the two intervention groups of NYHA class
研究者
Prof. Nicolas Verheyen
Scientific
Medical University Of Graz
研究点 (5)
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