NCT05771987招募中不适用
Permanent Pacing as a Treatment for Drug-refractory Symptomatic Patients With Obstructive Hypertrophic Cardiomyopathy.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Reduction of LVOT pressure gradient
研究概览
简要总结
The present trial is undertaken as a pilot study on selected patients, to evaluate the ability of acute hemodynamic testing to optimize pacing therapy and to predict the response of Obstructive Hypertrophic Cardiomyopathy (OHCM) to pacing, in terms of reduction of Left Ventricular Outflow Tract (LVOT) pressure gradient and functional capacity improvement.
The Primary Objective is to demonstrate a long-term reduction in LVOT obstruction at rest and/or after Valsalva/Exercise > 30% in patients responding to acute stimulation test
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •unequivocal diagnosis of HCM, on the basis of 2-dimensional echocardiographic demonstration of a hypertrophied (wall thickness >15 mm or > 13 mm in familial HOCM) and non dilated LV in the absence of another cardiac or systemic disease capable of producing the same magnitude of hypertrophy;
- •patients in whom coronary disease has been excluded;
- •presence of severe refractory symptoms (NYHA class II-IV), as evidenced by moderate-to-severe functional disability resulting from exertional dyspnea or chest pain sufficient to support a desire for alternative treatment modalities, following administration (in standard dosages) of beta-blocker and either disopyramide or verapamil, independently or in association;
- •peak instantaneous LV outflow tract gradient > 50 mm Hg (resting or provoked), estimated by continuous wave Doppler;
排除标准
- •end-stage phase of HCM (unless CRT therapy is considered);
- •ejection fraction <50% (unless CRT therapy is considered);
- •severe mitral valve disease (+++) not related to systolic anterior movement and/or papillary muscle abnormalities;
- •age below 18 years.
结局指标
主要结局
Reduction of LVOT pressure gradient
时间窗: 3 months
Long-term reduction in LVOT obstruction at rest and/or after Valsalva/Exercise \> 30% in patients responding to acute stimulation test
次要结局
- Clinical improvement: change in NYHA class(6-12 months)
- Clinical improvement: change in peak VO2(6-12 months)
- Clinical improvement: change in NT-proBNP concentration(6-12 months)
- Clinical improvement: change in exercise capacity(6-12 months)
研究者
研究点 (2)
Loading locations...
相似试验
尚未招募
不适用
Drug Eluting Temporary Spur Stent System vs Percutaneous Balloon Angioplasty for the Treatment of Critical Limb IschemiaCritical Limb IschemiaNCT06122974ReFlow Medical, Inc.518
已完成
不适用
Proactive Palliative Care for Patients With Ventricular Assist Devices (VAD) and Their FamiliesEnd-stage DiseaseHeart FailureNCT01427634Icahn School of Medicine at Mount Sinai18
招募中
2 期
Induction and Maintenance Treatment With PARP Inhibitor and Immunotherapy in HPV-negative HNSCCHead and Neck Squamous Cell CarcinomaNCT04681469Gruppo Oncologico del Nord-Ovest49
招募中
不适用
Sequential Therapies Modeled on Evolutionary Dynamics for Breast CancerMetastatic Breast CancerNCT06409390H. Lee Moffitt Cancer Center and Research Institute15
招募中
1 期
Evaluating the Efficacy of Platelet-Rich-Plasma (PRP) for Erectile DysfunctionErectile DysfunctionNCT06264635University of Manitoba60