Renal denervation in heart failure with preserved ejection fraction (RDF-PEF): a randomised controlled trial
File(s)
Supporting information
Accepted version
Author(s)
Type
Journal Article
Abstract
Aim
Heart failure with preserved ejection fraction (HFpEF) is associated with increased sympathetic nervous system (SNS) tone. Attenuating the SNS with renal denervation (RD) might be helpful and there are no data currently in humans with HFpEF.
Methods and Results
In this single-centre, randomised, 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 randomised (2:1) to RD 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 three months in the RD 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 RD procedure to treat renal artery wall oedema.
Conclusion
This study was terminated early due to 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 though two patients did require intra-procedure renal artery dilatation.
Heart failure with preserved ejection fraction (HFpEF) is associated with increased sympathetic nervous system (SNS) tone. Attenuating the SNS with renal denervation (RD) might be helpful and there are no data currently in humans with HFpEF.
Methods and Results
In this single-centre, randomised, 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 randomised (2:1) to RD 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 three months in the RD 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 RD procedure to treat renal artery wall oedema.
Conclusion
This study was terminated early due to 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 though two patients did require intra-procedure renal artery dilatation.
Date Issued
2016-03-16
Date Acceptance
2016-01-24
Citation
European Journal of Heart Failure, 2016, 18 (6), pp.703-712
ISSN
1879-0844
Publisher
Oxford University Press (OUP)
Start Page
703
End Page
712
Journal / Book Title
European Journal of Heart Failure
Volume
18
Issue
6
Copyright Statement
© 2016 The Authors European Journal of Heart Failure © 2016 European Society of Cardiology. This is the pre-peer reviewed version of the following article, which has been published in final form at http://onlinelibrary.wiley.com/doi/10.1002/ejhf.502/suppinfo
Subjects
Heart failure with preserved ejection fraction
Meta-iodo-benzyl-guanidine
Noradrenaline
Renal denervation
Sympathetic nervous system
Cardiovascular System & Hematology
1102 Cardiovascular Medicine And Haematology
Publication Status
Published