Denervation of the renAl sympathetIc nerveS in hearT Failure With nOrmal Lv Ejection Fraction (DIASTOLE)

Inclusion Criteria:

• Individual is diagnosed with heart failure with a normal LV ejection fraction. The diagnosis of HFNEF requires the following conditions to be satisfied:

  • signs or symptoms of heart failure;
  • normal or mildly abnormal systolic LV function (LVEF ≥ 50%);
  • evidence of diastolic LV dysfunction.
• Individual should fulfill the diagnostic WHO criteria for hypertension: SBP > 140 mmHg and/or DBP > 90 mmHg, and is treated with at least 2 antihypertensive drugs. This treatment is expected to be maintained for at least 6 months. Using this regimen the blood pressure should be adequately controlled (< 140/90mmHg by 24 hour ambulatory BP measurement).
• Individual is adhering to a stable drug regimen HFNEF, with no changes for a minimum of 2 weeks prior to enrollment, and which is expected to be maintained for at least 6 months.
• Individual is ≥ 18 years of age.

Exclusion Criteria:

• Known secondary cause of hypertension
• Anatomy not eligible for renal denervation
• Systolic heart failure (LVEF < 50%)
• Individual has an estimated glomerular filtration rate (eGFR) of < 30mL/min/1.73m2, using the MDRD calculation.
• Individual has any serious medical condition, which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant or the study (i.e., patients with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, haemophilia, significant anaemia, or arrhythmias such as atrial fibrillation).
• Individual is pregnant, nursing or planning to be pregnant.