Renal Denervation in Patients With Heart Failure With Normal LV Ejection Fraction

Transcatheter Renal Denervation in Heart Failure With Normal Left Ventricular Ejection Fraction - a Safety and Efficacy Study of Irrigated Radiofrequency Catheter

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.

Inclusion Criteria:

• 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;

Exclusion Criteria:

• 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