ACTRN12613000546752已完成3 期
A study of Renal Denervation for Heart Failure with Preserved Ejection Fraction to reduce left atrial volume index (LAVi) and/or left ventricular mass index (LVMi) on cardiac magnetic resonance imaging (cMRI).
Christchurch Heart Institute0 个研究点目标入组 20 人开始时间: 2013年5月15日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit(—)
- 性别
- All
入选标准
- •*Patients with HFPEF (based upon ESC diagnostic criteria)
- •a. Symptoms and signs of heart failure; NYHA Class II or higher
- •b. Left ventricular ejection fraction 50% or greater on echocardiography
- •c. Echocardiographic evidence of left ventricular diastolic dysfunction (echo-Doppler E/e’ > 15 ) AND/OR plasma NTproBNP > 220pg/ml.
- •*Episode of acute decompensation (ADHF) requiring hospital admission within the 12 months prior to recruitment
- •*Patients with and without background hypertension may be recruited. In the case of patients with background hypertension (ie history of fulfilling the diagnostic WHO criteria for hypertension: SBP > 140 mmHg and/or DBP > 90 mmHg) those with both controlled (<140/90mmHg by 24 hour ambulatory BP) and inadequately controlled BP (on 3 anti-hypertensive drugs including a diuretic) can be recruited.
排除标准
- •*Known secondary cause of hypertension
- •*Renal artery stenosis >30% or anatomy otherwise unsuitable for RDN.
- •* Heart failure with reduced LV ejection fraction (LVEF < 50%).
- •*Estimated glomerular filtration rate (eGFR) of < 30mL/min/1.73m2 (MDRD calculation).
- •*Systolic blood pressure < 105mmHg.
- •*Implanted pacemaker, prosthetic heart valve or other precluding cMR scanning.
- •*Medical condition adversely affecting safety and/or effectiveness of the participant (including peripheral vascular disease, abdominal aortic aneurysm, thrombocytopenia or uncontrolled atrial fibrillation).
- •*Pregnant, nursing or planning to be pregnant.
研究者
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