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

Hitesh C. Patel, Stuart D. Rosen, Carl Hayward, Vassilios Vassiliou, Gillian C. Smith, Ricardo R. Wage, James Bailey, Ronak Rajani, Alistair C. Lindsay, Dudley J. Pennell, S. Richard Underwood, Sanjay K. Prasad, Raad Mohiaddin, J. Simon R. Gibbs, Alexander R. Lyon, Carlo Di Mario

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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.
Original languageEnglish
Pages (from-to)703-712
Number of pages10
JournalEuropean Journal of Heart Failure
Volume18
Issue number6
Early online date16 Mar 2016
DOIs
Publication statusPublished - Jun 2016

Keywords

  • Heart failure with preserved ejection fraction
  • Renal denervation
  • Sympathetic nervous system
  • Meta-iodo-benzyl-guanidine
  • Noradrenaline

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