NCT02115230Unknown不适用
Transcatheter Renal Denervation in Heart Failure With Normal Left Ventricular Ejection Fraction - a Safety and Efficacy Study of Irrigated Radiofrequency Catheter
InCor Heart Institute2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2014年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Efficacy: Change from baseline E/E' on echocardiography at 12 months
研究概览
简要总结
It is a randomized prospective controlled study of transcatheter renal denervation in patients with Heart Failure With Normal LV Ejection Fraction. The purpose of the study is to evaluate the safety and effectiveness of renal denervation in patients with Heart Failure With Normal LV Ejection Fraction, due to reduction in renal and systemic sympathetic activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hypertension treated with at least 2 antihypertensive drugs;
- •Heart failure with a normal LV ejection fraction;
- •Left Ventricular Hypertrophy (LV mass index > 96 g/m2 in women and > 116 g/m2 in men);
- •≥ 18 years of age;
排除标准
- •Known secondary cause of hypertension
- •Uncontrolled blood pressure (≥ 180x110mmHg)
- •Unsuitable anatomy of renal arteries, renal stenosis or previous treatment with balloon or stent
- •Advanced renal insufficiency (estimated glomerular filtration rate (GFR) < 30 ml/min/1.73 square meters)
- •Diabetes Mellitus type 1
- •Acute coronary syndrome or a cerebrovascular accident in the last 6 months
- •Known other cause of respiratory dysfunction
- •Previous LV systolic dysfunction (LVEF < 50%)
- •Restrictive cardiomyopathy or Hypertrophic cardiomyopathy
- •Significant valvar dysfunction
- •Atrial flutter or atrial fibrillation
- •Use of the oral anticoagulants
- •Drug and Alcohol dependence
结局指标
主要结局
Efficacy: Change from baseline E/E' on echocardiography at 12 months
时间窗: 12 months after treatment
Safety: Composite of death, myocardial infarction, cerebrovascular event, need of intervention on renal arteries and renal function impairment (decrease in estimated GFR > 30% from baseline)
时间窗: 12 months
次要结局
- Change in quality of life (Minnesota Living with Heart Failure Questionnaire) between baseline and 12 months(12 months)
- Change from baseline E/E' on echocardiography at 6 months(6 months)
- Change of office blood pressure and ambulatory blood pressure monitoring (ABPM) between baseline and 12 months(12 months)
- Change in any echocardiographic diastolic parameter between baseline and 12 months(12 months)
- Change in 6 min walking distance between baseline and 12 months(12 months)
- Change in serum B-type natriuretic peptide (BNP) between baseline and 12 months(12 months)
- Change in non-invasive hemodynamic parameters provided by Finometer between baseline and 12 months(12 months)
- Change in renal function (GFR, albuminury and 24h urinary Na excretion) between baseline and 12 months(12 months)
- Change in peripheral sympathetic activity measured by microneurography between baseline and 12 months(12 months)
研究者
Pedro A. Lemos
Pedro A. Lemos, Professor of Medicine, InCor Heart Institute
InCor Heart Institute
研究点 (2)
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