跳至主要内容
临床试验/ACTRN12613000546752
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

发起方
Christchurch Heart Institute

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