Table 6.
Clinical evidence for the use of renal denervation in HFpEF
| Author or trial name | Investigational device | Design | Inclusion criteria | Sample size | Follow‐up | Primary efficacy and safety outcome |
|---|---|---|---|---|---|---|
| RDT‐PEF 63 | Medtronic Symplicity Spyral™ | Phase II, single‐centre, prospective, randomized, controlled, open‐label and blinded end‐point trial | NYHA class II–III, LVEF ≥50% | RDN (n = 17), control (n = 8) | 12 months | No differences between groups at 12 months for MLWHFQ score, VO2 on exercise, BNP, E/e′, left atrial volume index or LV mass index |
| Kresoja KP et al. 64 | Medtronic Symplicity Spyral™ or and ultrasound RDN (Paradise, ReCor Medical, Palo Alto, CA). | Single‐centre, retrospective observational study | NA | 99 | NA | LV diastolic stiffness and LV filling pressures as well as NT‐proBNP decreased |
| Ongoing UNLOAD‐HFpEF | Ultrasound RDN (Paradise, ReCor Medical, Palo Alto, CA) | Single‐centre, randomized, sham‐controlled double‐blind | NYHA class II or III, LVEF ≥55% | 68 | 6 months | NA |
Abbreviations: BNP, B‐type natriuretic peptides; LV, left ventricular; LVEF, left ventricular ejection fraction; MLWHFQ, Minnesota Living With Heart Failure Questionnaire; NA, not applicable; NT‐proBNP, N‐terminal pro‐B‐type natriuretic peptide; NYHA, New York Heart Association; RDN, renal denervation; VO2, peak oxygen uptake.