RADIANCE-HTN SOLO RESULTS

 

RADIANCE-HTN SOLO is a multicenter, international, blinded, randomised, sham-controlled trial to evaluate use of the Paradise Renal Denervation System to reduce ambulatory blood pressure in patients with hypertension in the absence of antihypertensive medications.

KEY TAKE-AWAYS

The Paradise Renal Denervation System lowered blood pressure in patients with hypertension who were randomized and followed for 2 months off medications, demonstrating:

  • Greater reduction in daytime ambulatory systolic BP than a sham procedure.
  • Consistent reductions in 24-hour ambulatory, office, and home BP.
  • Reduction of ≥5 mmHg observed in 66% of treated patients.
  • No major adverse events within 30 days of the procedure.

STUDY DESIGN

  • Trial was conducted at 21 centers in the USA and 18 in Europe.
  • 146 patients were randomized (1:1) to renal denervation or sham procedure (renal angiography)
    after a 4 week antihypertensive medication washout.
  • Primary Efficacy Endpoint: Change in Daytime Ambulatory Systolic BP at 2 Months.

Primary Endpoint:  Change in Daytime Ambulatory Systolic BP at 2 Months

*Between group difference adjusted for baseline blood pressure
**The per-protocol population omitted patients who started medications prior to end-point collection

Azizi et al. Lancet. 2018 Jun 9;391(10137):2335-2345.

ADDITIONAL FINDINGS

*Between group difference adjusted for baseline blood pressure
Azizi et al. Lancet. 2018 Jun 9;391(10137):2335-2345.

Azizi et al. Lancet. 2018 Jun 9;391(10137):2335-2345.

Average Hourly BP at Baseline and 2 Months Per Protocol

Azizi et al. ESH 2018.

Learn more about the RADIANCE-HTN study results
and the Paradise Renal Denervation System

REFERENCES

 

Paradise Renal Denervation System Clinical Evidence

Azizi et al.  Endovascular ultrasound renal denervation to treat hypertension (RADIANCE-HTN SOLO): a multicentre, international, single-blind, randomised, sham-controlled trial. Lancet. 2018 Jun 9;391(10137):2335-2345.
https://www.ncbi.nlm.nih.gov/pubmed/29803590

Fengler et al.  Predictors for profound blood pressure response in patients undergoing renal sympathetic denervation. J Hypertens. 2018 Jul;36(7):1578-1584.
https://www.ncbi.nlm.nih.gov/pubmed/29652730

Daemen et al.  Safety And Efficacy Of Renal Sympathetic Denervation Using Circumferential Ultrasound: 12-month Results of the ACHIEVE Study. JACC Cardiovasc Interv 2018; 11: S33 (abstr)
http://interventions.onlinejacc.org/content/11/4_Supplement/S33.1

Fengler et al.  Ultrasound-based renal sympathetic denervation for the treatment of therapy-resistant hypertension: a single-center experience. Hypertens. 2017 Jun;35(6):1310-1317.
https://www.ncbi.nlm.nih.gov/pubmed/28441700

Stiermaier et al.  Endovascular ultrasound for renal sympathetic denervation in patients with therapy-resistant hypertension not responding to radiofrequency renal sympathetic denervation. EuroIntervention. 2016 Jun 12;12(2):e282-9.
https://www.ncbi.nlm.nih.gov/pubmed/27290688

Daemen et al.  First-in-man radial access renal denervation with the ReCor Radiance catheter. EuroIntervention. 2015 Feb;10(10):1209-12.
https://www.ncbi.nlm.nih.gov/pubmed/25493912

Mauri et al.  A multinational clinical approach to assessing the effectiveness of catheter-based ultrasound renal denervation: The RADIANCE-HTN and REQUIRE clinical study designs. Am Heart J. 2018 Jan;195:115-129.
https://www.ncbi.nlm.nih.gov/pubmed/29224639

 

RENAL DENERVATION CLINICAL EVIDENCE

Schmieder et al.  European Society of Hypertension position paper on renal denervation 2018. J Hypertens. 2018 Jul 13.  
https://www.ncbi.nlm.nih.gov/pubmed/30015759

Schlaich et al.  Renal Denervation—Ready for Prime Time!? The Steep SPYRAL Stairs to RADIANCE in Hypertension Treatment. Hypertension. 2018 Aug;72(2):287-290
https://www.ncbi.nlm.nih.gov/pubmed/29941510

Kandzari et al.  Effect of renal denervation on blood pressure in the presence of antihypertensive drugs: 6-month efficacy and safety results from the SPYRAL HTN-ON MED proof-of-concept randomised trial. Lancet. 2018 Jun 9;391(10137):2346-2355.
https://www.ncbi.nlm.nih.gov/pubmed/29803589

Townsend et al.  Catheter-based renal denervation in patients with uncontrolled hypertension in the absence of antihypertensive medications (SPYRAL HTN-OFF MED): a randomised, sham-controlled, proof-of-concept trial. Lancet. 2017 Nov 11;390(10108):2160-2170.
https://www.ncbi.nlm.nih.gov/pubmed/28859944

Azizi et al.  Optimum and stepped care standardised antihypertensive treatment with or without renal denervation for resistant hypertension (DENERHTN): a multicentre, open-label, randomised controlled trial. Lancet. 2015 May 16;385(9981):1957-65.
https://www.ncbi.nlm.nih.gov/pubmed/25631070

Volza et al.  Renal sympathetic denervation in Sweden: a report from the Swedish registry for renal denervation. J Hypertens. 2018 Jan;36(1):151-158.
https://www.ncbi.nlm.nih.gov/pubmed/29210862

Fengler et al.  Pulse Wave Velocity Predicts Response to Renal Denervation in Isolated Systolic Hypertension. J Am Heart Assoc. 2017 May 17;6(5).
https://www.ncbi.nlm.nih.gov/pubmed/28515119

Kandzari et al.  The SPYRAL HTN Global Clinical Trial Program: Rationale and design for studies of renal denervation in the absence (SPYRAL HTN OFF-MED) and presence (SPYRAL HTN ON-MED) of antihypertensive medications. Am Heart J. 2016 Jan;171(1):82-91.
https://www.ncbi.nlm.nih.gov/pubmed/26699604

Mahfoud et al.  Proceedings from the 2nd European Clinical Consensus Conference for device-based therapies for hypertension: state of the art and considerations for the future. Eur Heart J. 2017 Nov 21;38(44):3272-3281.
https://www.ncbi.nlm.nih.gov/pubmed/28475773

Mahfoud et al.  Proceedings from the European clinical consensus conference for renal denervation: considerations on future clinical trial design. Eur Heart J. 2015 Sep 1;36(33):2219-27.
https://www.ncbi.nlm.nih.gov/pubmed/25990344

 

Renal Denervation Basic Science

Sakakura et al.  Controlled circumferential renal sympathetic denervation with preservation of the renal arterial wall using intraluminal ultrasound: a next-generation approach for treating sympathetic overactivity. EuroIntervention 2015; 10: 1230–8.
https://www.ncbi.nlm.nih.gov/pubmed/25349043

Pathak et al. Renal sympathetic nerve denervation using intraluminal ultrasound within a cooling balloon preserves the arterial wall and reduces sympathetic nerve activity. EuroIntervention. 2015 Aug;11(4):477-84.
https://www.ncbi.nlm.nih.gov/pubmed/26298415