Renal denervation in heart failure with preserved ejection fraction (RDT-PEF): a randomized controlled trial

Eur J Heart Fail. 2016 Jun;18(6):703-12. doi: 10.1002/ejhf.502. Epub 2016 Mar 16.

Abstract

Aim: Heart failure with preserved ejection fraction (HFpEF) is associated with increased sympathetic nervous system (SNS) tone. Attenuating the SNS with renal denervation (RDT) might be helpful and there are no data currently in humans with HFpEF.

Methods and results: In this single-centre, randomized, open-controlled study we included 25 patients with HFpEF [preserved left ventricular (LV) ejection fraction, left atrial (LA) dilatation or LV hypertrophy and raised B-type natriuretic peptide (BNP) or echocardiographic assessment of filling pressures]. Patients were randomized (2:1) to RDT with the Symplicity™ catheter or continuing medical therapy. The primary success criterion was not met in that there were no differences between groups at 12 months for Minnesota Living with Heart Failure Questionnaire score, peak oxygen uptake (VO2 ) on exercise, BNP, E/e', LA volume index or LV mass index. A greater proportion of patients improved at 3 months in the RDT group with respect to VO2 peak (56% vs. 13%, P = 0.025) and E/e' (31% vs. 13%, P = 0.04). Change in estimated glomerular filtration rate was comparable between groups. Two patients required plain balloon angioplasty during the RDT procedure to treat renal artery wall oedema.

Conclusion: This study was terminated early because of difficulties in recruitment and was underpowered to detect whether RD improved the endpoints of quality of life, exercise function, biomarkers, and left heart remodelling. The procedure was safe in patients with HFpEF, although two patients did require intraprocedure renal artery dilatation.

Keywords: Heart failure with preserved ejection fraction; Meta-iodo-benzyl-guanidine; Noradrenaline; Renal denervation; Sympathetic nervous system.

Publication types

  • Clinical Trial, Phase II
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Denervation*
  • Echocardiography
  • Exercise Tolerance
  • Female
  • Heart Atria / diagnostic imaging
  • Heart Atria / pathology
  • Heart Failure / blood
  • Heart Failure / complications
  • Heart Failure / diagnostic imaging
  • Heart Failure / surgery*
  • Heart Ventricles / diagnostic imaging
  • Heart Ventricles / pathology
  • Humans
  • Hypertrophy, Left Ventricular / diagnostic imaging
  • Hypertrophy, Left Ventricular / etiology
  • Male
  • Natriuretic Peptide, Brain / blood
  • Organ Size
  • Oxygen Consumption
  • Renal Artery / innervation*
  • Stroke Volume
  • Sympathectomy*

Substances

  • Natriuretic Peptide, Brain