| Trial, year of publication . | Investigational device . | Design (randomisation ratio) . | Sample size . | Inclusion criteria . | Primary efficacy outcome . | BP reduction in RDN vs control group . |
|---|---|---|---|---|---|---|
| Randomised controlled trials | ||||||
| Symplicity HTN-2, 201092 | Symplicity Flex (mono-electrode RF) | Open-label, RDN vs control (1:1) | 106 | Uncontrolled office BP on ≥3 antihypertensive drugs | Change in office SBP at 6 months | −32 ± 23 vs −1 ± 21 mmHg; p < 0.0001 |
| DENERHTN, 201593 | Symplicity Flex (mono-electrode RF) | Open-label, SSAHT + RDN vs SSAHT (1:1) | 106 | Uncontrolled office and 24-hr BP on ≥3 antihypertensive drugs | Change in daytime ambulatory SBP at 6 months | −9.9 (95% CI: −13.6 to −6.2) vs −5.9 mmHg (95% CI: −11.3 to −0.5); p = 0.033 |
| RADIOSOUND-HTN, 201994 | Symplicity Spyral (multi-electrode RF) vs Paradise (US) | US-RDN vs RF-RDN of the main artery vs RF-RDN of main artery vs RF-RDN of the branches, and accessory arteries (1:1:1) | 120 | Uncontrolled office and 24-hr BP on ≥3 antihypertensive drugs | Change in daytime ambulatory SBP at 3 months | US: −13.2 ± 13.7 mmHg vs RF main artery: 6.5 ± 10.3 mmHg vs RF including branches: −8.3 ± 11.7 mmHg (p = 0.043 for US vs RF main artery; p > 0.99 for RF main artery vs RF branches) |
| First-generation randomised sham-controlled trials | ||||||
| Symplicity HTN-3, 201416 | Symplicity Flex (mono-electrode RF) | RDN vs sham (2:1) | 535 | Uncontrolled office and 24-hr BP on ≥3 antihypertensive drugs | Change in office SBP at 6 months | −14.1 ± 23.9 vs −11.7 ± 25.9 mmHg; p = 0.27 |
| RSD-Leipzig, 201595 | Symplicity Flex (mono-electrode RF) | RDN vs sham (1:1) | 71 | Uncontrolled 24-hr BP on ≥3 antihypertensive drugs | Change in 24-hr SBP at 6 months | −7.0 (95% CI: −10.8 to −3.2) vs −3.5 mmHg (95% CI: −6.7 to −0.2); p = 0.15 |
| ReSET, 201696 | Symplicity Flex (mono-electrode RF) | RDN vs sham (1:1) | 69 | Uncontrolled daytime ambulatory BP on ≥3 antihypertensive drugs | Change in daytime ambulatory SBP at 6 months | −6.1 ± 18.9 vs −4.3 ± 15.1 mmHg; p = 0.66 |
| WAVE IV, 201797 | Externally delivered therapeutic US energy (surround sound system) | RDN vs sham (1:1) | 81 | Uncontrolled office and 24-hr BP on ≥3 antihypertensive drugs | Change in office SBP | −13.2 ± 20 vs −18.9 ± 14 mmHg; p = 0.181 |
| REDUCE-HTN: REINFORCE, 202098 | Vessix (multi-electrode RF) | RDN vs sham (2:1) | 51 | Uncontrolled office and 24-hr BP in absence of antihypertensive drugs | Change in 24-hr SBP at 2 months | −5.3 (95% CI: −8.8 to −1.8) vs −8.5 mmHg (95% CI: −13.3 to −3.8); p = 0.30 |
| Second-generation randomised sham-controlled trials | ||||||
| SPYRAL HTN-OFF MED Pilot, 20179 | Symplicity Spyral (multi-electrode RF) | RDN vs sham (1:1) | 80 | Uncontrolled office and 24-hr BP in the absence of antihypertensive drugs | Change in 24-hr SBP at 3 months | −5.5 (95% CI: −9.1 to −2.0) vs −0.5 mmHg (95% CI: −3.9 to 2.90); p = 0.0414 |
| RADIANCE-HTN SOLO, 201812 | Paradise (US) | RDN vs sham (1:1) | 146 | Uncontrolled daytime ambulatory BP in the absence of antihypertensive drugs | Change in daytime ambulatory SBP at 2 months | −8.5 ± 9.3 vs −2.2 ± 10.0 mmHg; p = 0.0001 |
| SPYRAL HTN-ON MED, 201810 | Symplicity Spyral (multi-electrode RF) | RDN vs sham (1:1) | 80 | Uncontrolled office and 24-hr BP on 1 to 3 antihypertensive drugs | Change in 24-hr SBP at 6 months | −9.0 (95% CI: −12.7 to −5.3) vs −1.6 mmHg (95% CI: −5.2 to 2.0); p = 0.006 |
| SPYRAL HTN-OFF MED Pivotal, 202011 | Symplicity Spyral (multi-electrode RF) | Bayesian adaptive design, RDN vs sham (1:1) | 331 | Uncontrolled office and 24-hr BP, in the absence of antihypertensive drugs | Change in 24-hr SBP at 3 months | −4.7 (95% CI: −6.4 to −2.9) vs −0.6 mmHg (95% CI: −2.1 to 0.9); p = 0.0005 |
| RADIANCE-HTN TRIO, 202113 | Paradise (US) | RDN vs sham (1:1) | 136 | Uncontrolled office and daytime ambulatory BP on 3 antihypertensive drugs | Change in daytime ambulatory SBP at 2 months | −8.0 (IQR −16.4, 0.0) vs −3.0 mmHg (IQR −10.3, 1.8); p = 0.022 |
| REQUIRE, 202219 | Paradise (US) | RDN vs sham (1:1) | 143 | Uncontrolled office and 24-hr BP on ≥3 antihypertensive drugs | Change in daytime ambulatory SBP at 3 months | −6.6 (95% CI: −10.4 to −2.8) vs −6.5 mmHg (95% CI: −10.3 to −2.7); p = 0.971 |
| Trial, year of publication . | Investigational device . | Design (randomisation ratio) . | Sample size . | Inclusion criteria . | Primary efficacy outcome . | BP reduction in RDN vs control group . |
|---|---|---|---|---|---|---|
| Randomised controlled trials | ||||||
| Symplicity HTN-2, 201092 | Symplicity Flex (mono-electrode RF) | Open-label, RDN vs control (1:1) | 106 | Uncontrolled office BP on ≥3 antihypertensive drugs | Change in office SBP at 6 months | −32 ± 23 vs −1 ± 21 mmHg; p < 0.0001 |
| DENERHTN, 201593 | Symplicity Flex (mono-electrode RF) | Open-label, SSAHT + RDN vs SSAHT (1:1) | 106 | Uncontrolled office and 24-hr BP on ≥3 antihypertensive drugs | Change in daytime ambulatory SBP at 6 months | −9.9 (95% CI: −13.6 to −6.2) vs −5.9 mmHg (95% CI: −11.3 to −0.5); p = 0.033 |
| RADIOSOUND-HTN, 201994 | Symplicity Spyral (multi-electrode RF) vs Paradise (US) | US-RDN vs RF-RDN of the main artery vs RF-RDN of main artery vs RF-RDN of the branches, and accessory arteries (1:1:1) | 120 | Uncontrolled office and 24-hr BP on ≥3 antihypertensive drugs | Change in daytime ambulatory SBP at 3 months | US: −13.2 ± 13.7 mmHg vs RF main artery: 6.5 ± 10.3 mmHg vs RF including branches: −8.3 ± 11.7 mmHg (p = 0.043 for US vs RF main artery; p > 0.99 for RF main artery vs RF branches) |
| First-generation randomised sham-controlled trials | ||||||
| Symplicity HTN-3, 201416 | Symplicity Flex (mono-electrode RF) | RDN vs sham (2:1) | 535 | Uncontrolled office and 24-hr BP on ≥3 antihypertensive drugs | Change in office SBP at 6 months | −14.1 ± 23.9 vs −11.7 ± 25.9 mmHg; p = 0.27 |
| RSD-Leipzig, 201595 | Symplicity Flex (mono-electrode RF) | RDN vs sham (1:1) | 71 | Uncontrolled 24-hr BP on ≥3 antihypertensive drugs | Change in 24-hr SBP at 6 months | −7.0 (95% CI: −10.8 to −3.2) vs −3.5 mmHg (95% CI: −6.7 to −0.2); p = 0.15 |
| ReSET, 201696 | Symplicity Flex (mono-electrode RF) | RDN vs sham (1:1) | 69 | Uncontrolled daytime ambulatory BP on ≥3 antihypertensive drugs | Change in daytime ambulatory SBP at 6 months | −6.1 ± 18.9 vs −4.3 ± 15.1 mmHg; p = 0.66 |
| WAVE IV, 201797 | Externally delivered therapeutic US energy (surround sound system) | RDN vs sham (1:1) | 81 | Uncontrolled office and 24-hr BP on ≥3 antihypertensive drugs | Change in office SBP | −13.2 ± 20 vs −18.9 ± 14 mmHg; p = 0.181 |
| REDUCE-HTN: REINFORCE, 202098 | Vessix (multi-electrode RF) | RDN vs sham (2:1) | 51 | Uncontrolled office and 24-hr BP in absence of antihypertensive drugs | Change in 24-hr SBP at 2 months | −5.3 (95% CI: −8.8 to −1.8) vs −8.5 mmHg (95% CI: −13.3 to −3.8); p = 0.30 |
| Second-generation randomised sham-controlled trials | ||||||
| SPYRAL HTN-OFF MED Pilot, 20179 | Symplicity Spyral (multi-electrode RF) | RDN vs sham (1:1) | 80 | Uncontrolled office and 24-hr BP in the absence of antihypertensive drugs | Change in 24-hr SBP at 3 months | −5.5 (95% CI: −9.1 to −2.0) vs −0.5 mmHg (95% CI: −3.9 to 2.90); p = 0.0414 |
| RADIANCE-HTN SOLO, 201812 | Paradise (US) | RDN vs sham (1:1) | 146 | Uncontrolled daytime ambulatory BP in the absence of antihypertensive drugs | Change in daytime ambulatory SBP at 2 months | −8.5 ± 9.3 vs −2.2 ± 10.0 mmHg; p = 0.0001 |
| SPYRAL HTN-ON MED, 201810 | Symplicity Spyral (multi-electrode RF) | RDN vs sham (1:1) | 80 | Uncontrolled office and 24-hr BP on 1 to 3 antihypertensive drugs | Change in 24-hr SBP at 6 months | −9.0 (95% CI: −12.7 to −5.3) vs −1.6 mmHg (95% CI: −5.2 to 2.0); p = 0.006 |
| SPYRAL HTN-OFF MED Pivotal, 202011 | Symplicity Spyral (multi-electrode RF) | Bayesian adaptive design, RDN vs sham (1:1) | 331 | Uncontrolled office and 24-hr BP, in the absence of antihypertensive drugs | Change in 24-hr SBP at 3 months | −4.7 (95% CI: −6.4 to −2.9) vs −0.6 mmHg (95% CI: −2.1 to 0.9); p = 0.0005 |
| RADIANCE-HTN TRIO, 202113 | Paradise (US) | RDN vs sham (1:1) | 136 | Uncontrolled office and daytime ambulatory BP on 3 antihypertensive drugs | Change in daytime ambulatory SBP at 2 months | −8.0 (IQR −16.4, 0.0) vs −3.0 mmHg (IQR −10.3, 1.8); p = 0.022 |
| REQUIRE, 202219 | Paradise (US) | RDN vs sham (1:1) | 143 | Uncontrolled office and 24-hr BP on ≥3 antihypertensive drugs | Change in daytime ambulatory SBP at 3 months | −6.6 (95% CI: −10.4 to −2.8) vs −6.5 mmHg (95% CI: −10.3 to −2.7); p = 0.971 |
BP: blood pressure; CI: confidence interval; IQR: interquartile ratio; RDN: renal denervation; RF: radiofrequency; SBP: systolic blood pressure; SSAHT: standardised stepped-care antihypertensive treatment; US: ultrasound
| Trial, year of publication . | Investigational device . | Design (randomisation ratio) . | Sample size . | Inclusion criteria . | Primary efficacy outcome . | BP reduction in RDN vs control group . |
|---|---|---|---|---|---|---|
| Randomised controlled trials | ||||||
| Symplicity HTN-2, 201092 | Symplicity Flex (mono-electrode RF) | Open-label, RDN vs control (1:1) | 106 | Uncontrolled office BP on ≥3 antihypertensive drugs | Change in office SBP at 6 months | −32 ± 23 vs −1 ± 21 mmHg; p < 0.0001 |
| DENERHTN, 201593 | Symplicity Flex (mono-electrode RF) | Open-label, SSAHT + RDN vs SSAHT (1:1) | 106 | Uncontrolled office and 24-hr BP on ≥3 antihypertensive drugs | Change in daytime ambulatory SBP at 6 months | −9.9 (95% CI: −13.6 to −6.2) vs −5.9 mmHg (95% CI: −11.3 to −0.5); p = 0.033 |
| RADIOSOUND-HTN, 201994 | Symplicity Spyral (multi-electrode RF) vs Paradise (US) | US-RDN vs RF-RDN of the main artery vs RF-RDN of main artery vs RF-RDN of the branches, and accessory arteries (1:1:1) | 120 | Uncontrolled office and 24-hr BP on ≥3 antihypertensive drugs | Change in daytime ambulatory SBP at 3 months | US: −13.2 ± 13.7 mmHg vs RF main artery: 6.5 ± 10.3 mmHg vs RF including branches: −8.3 ± 11.7 mmHg (p = 0.043 for US vs RF main artery; p > 0.99 for RF main artery vs RF branches) |
| First-generation randomised sham-controlled trials | ||||||
| Symplicity HTN-3, 201416 | Symplicity Flex (mono-electrode RF) | RDN vs sham (2:1) | 535 | Uncontrolled office and 24-hr BP on ≥3 antihypertensive drugs | Change in office SBP at 6 months | −14.1 ± 23.9 vs −11.7 ± 25.9 mmHg; p = 0.27 |
| RSD-Leipzig, 201595 | Symplicity Flex (mono-electrode RF) | RDN vs sham (1:1) | 71 | Uncontrolled 24-hr BP on ≥3 antihypertensive drugs | Change in 24-hr SBP at 6 months | −7.0 (95% CI: −10.8 to −3.2) vs −3.5 mmHg (95% CI: −6.7 to −0.2); p = 0.15 |
| ReSET, 201696 | Symplicity Flex (mono-electrode RF) | RDN vs sham (1:1) | 69 | Uncontrolled daytime ambulatory BP on ≥3 antihypertensive drugs | Change in daytime ambulatory SBP at 6 months | −6.1 ± 18.9 vs −4.3 ± 15.1 mmHg; p = 0.66 |
| WAVE IV, 201797 | Externally delivered therapeutic US energy (surround sound system) | RDN vs sham (1:1) | 81 | Uncontrolled office and 24-hr BP on ≥3 antihypertensive drugs | Change in office SBP | −13.2 ± 20 vs −18.9 ± 14 mmHg; p = 0.181 |
| REDUCE-HTN: REINFORCE, 202098 | Vessix (multi-electrode RF) | RDN vs sham (2:1) | 51 | Uncontrolled office and 24-hr BP in absence of antihypertensive drugs | Change in 24-hr SBP at 2 months | −5.3 (95% CI: −8.8 to −1.8) vs −8.5 mmHg (95% CI: −13.3 to −3.8); p = 0.30 |
| Second-generation randomised sham-controlled trials | ||||||
| SPYRAL HTN-OFF MED Pilot, 20179 | Symplicity Spyral (multi-electrode RF) | RDN vs sham (1:1) | 80 | Uncontrolled office and 24-hr BP in the absence of antihypertensive drugs | Change in 24-hr SBP at 3 months | −5.5 (95% CI: −9.1 to −2.0) vs −0.5 mmHg (95% CI: −3.9 to 2.90); p = 0.0414 |
| RADIANCE-HTN SOLO, 201812 | Paradise (US) | RDN vs sham (1:1) | 146 | Uncontrolled daytime ambulatory BP in the absence of antihypertensive drugs | Change in daytime ambulatory SBP at 2 months | −8.5 ± 9.3 vs −2.2 ± 10.0 mmHg; p = 0.0001 |
| SPYRAL HTN-ON MED, 201810 | Symplicity Spyral (multi-electrode RF) | RDN vs sham (1:1) | 80 | Uncontrolled office and 24-hr BP on 1 to 3 antihypertensive drugs | Change in 24-hr SBP at 6 months | −9.0 (95% CI: −12.7 to −5.3) vs −1.6 mmHg (95% CI: −5.2 to 2.0); p = 0.006 |
| SPYRAL HTN-OFF MED Pivotal, 202011 | Symplicity Spyral (multi-electrode RF) | Bayesian adaptive design, RDN vs sham (1:1) | 331 | Uncontrolled office and 24-hr BP, in the absence of antihypertensive drugs | Change in 24-hr SBP at 3 months | −4.7 (95% CI: −6.4 to −2.9) vs −0.6 mmHg (95% CI: −2.1 to 0.9); p = 0.0005 |
| RADIANCE-HTN TRIO, 202113 | Paradise (US) | RDN vs sham (1:1) | 136 | Uncontrolled office and daytime ambulatory BP on 3 antihypertensive drugs | Change in daytime ambulatory SBP at 2 months | −8.0 (IQR −16.4, 0.0) vs −3.0 mmHg (IQR −10.3, 1.8); p = 0.022 |
| REQUIRE, 202219 | Paradise (US) | RDN vs sham (1:1) | 143 | Uncontrolled office and 24-hr BP on ≥3 antihypertensive drugs | Change in daytime ambulatory SBP at 3 months | −6.6 (95% CI: −10.4 to −2.8) vs −6.5 mmHg (95% CI: −10.3 to −2.7); p = 0.971 |
| Trial, year of publication . | Investigational device . | Design (randomisation ratio) . | Sample size . | Inclusion criteria . | Primary efficacy outcome . | BP reduction in RDN vs control group . |
|---|---|---|---|---|---|---|
| Randomised controlled trials | ||||||
| Symplicity HTN-2, 201092 | Symplicity Flex (mono-electrode RF) | Open-label, RDN vs control (1:1) | 106 | Uncontrolled office BP on ≥3 antihypertensive drugs | Change in office SBP at 6 months | −32 ± 23 vs −1 ± 21 mmHg; p < 0.0001 |
| DENERHTN, 201593 | Symplicity Flex (mono-electrode RF) | Open-label, SSAHT + RDN vs SSAHT (1:1) | 106 | Uncontrolled office and 24-hr BP on ≥3 antihypertensive drugs | Change in daytime ambulatory SBP at 6 months | −9.9 (95% CI: −13.6 to −6.2) vs −5.9 mmHg (95% CI: −11.3 to −0.5); p = 0.033 |
| RADIOSOUND-HTN, 201994 | Symplicity Spyral (multi-electrode RF) vs Paradise (US) | US-RDN vs RF-RDN of the main artery vs RF-RDN of main artery vs RF-RDN of the branches, and accessory arteries (1:1:1) | 120 | Uncontrolled office and 24-hr BP on ≥3 antihypertensive drugs | Change in daytime ambulatory SBP at 3 months | US: −13.2 ± 13.7 mmHg vs RF main artery: 6.5 ± 10.3 mmHg vs RF including branches: −8.3 ± 11.7 mmHg (p = 0.043 for US vs RF main artery; p > 0.99 for RF main artery vs RF branches) |
| First-generation randomised sham-controlled trials | ||||||
| Symplicity HTN-3, 201416 | Symplicity Flex (mono-electrode RF) | RDN vs sham (2:1) | 535 | Uncontrolled office and 24-hr BP on ≥3 antihypertensive drugs | Change in office SBP at 6 months | −14.1 ± 23.9 vs −11.7 ± 25.9 mmHg; p = 0.27 |
| RSD-Leipzig, 201595 | Symplicity Flex (mono-electrode RF) | RDN vs sham (1:1) | 71 | Uncontrolled 24-hr BP on ≥3 antihypertensive drugs | Change in 24-hr SBP at 6 months | −7.0 (95% CI: −10.8 to −3.2) vs −3.5 mmHg (95% CI: −6.7 to −0.2); p = 0.15 |
| ReSET, 201696 | Symplicity Flex (mono-electrode RF) | RDN vs sham (1:1) | 69 | Uncontrolled daytime ambulatory BP on ≥3 antihypertensive drugs | Change in daytime ambulatory SBP at 6 months | −6.1 ± 18.9 vs −4.3 ± 15.1 mmHg; p = 0.66 |
| WAVE IV, 201797 | Externally delivered therapeutic US energy (surround sound system) | RDN vs sham (1:1) | 81 | Uncontrolled office and 24-hr BP on ≥3 antihypertensive drugs | Change in office SBP | −13.2 ± 20 vs −18.9 ± 14 mmHg; p = 0.181 |
| REDUCE-HTN: REINFORCE, 202098 | Vessix (multi-electrode RF) | RDN vs sham (2:1) | 51 | Uncontrolled office and 24-hr BP in absence of antihypertensive drugs | Change in 24-hr SBP at 2 months | −5.3 (95% CI: −8.8 to −1.8) vs −8.5 mmHg (95% CI: −13.3 to −3.8); p = 0.30 |
| Second-generation randomised sham-controlled trials | ||||||
| SPYRAL HTN-OFF MED Pilot, 20179 | Symplicity Spyral (multi-electrode RF) | RDN vs sham (1:1) | 80 | Uncontrolled office and 24-hr BP in the absence of antihypertensive drugs | Change in 24-hr SBP at 3 months | −5.5 (95% CI: −9.1 to −2.0) vs −0.5 mmHg (95% CI: −3.9 to 2.90); p = 0.0414 |
| RADIANCE-HTN SOLO, 201812 | Paradise (US) | RDN vs sham (1:1) | 146 | Uncontrolled daytime ambulatory BP in the absence of antihypertensive drugs | Change in daytime ambulatory SBP at 2 months | −8.5 ± 9.3 vs −2.2 ± 10.0 mmHg; p = 0.0001 |
| SPYRAL HTN-ON MED, 201810 | Symplicity Spyral (multi-electrode RF) | RDN vs sham (1:1) | 80 | Uncontrolled office and 24-hr BP on 1 to 3 antihypertensive drugs | Change in 24-hr SBP at 6 months | −9.0 (95% CI: −12.7 to −5.3) vs −1.6 mmHg (95% CI: −5.2 to 2.0); p = 0.006 |
| SPYRAL HTN-OFF MED Pivotal, 202011 | Symplicity Spyral (multi-electrode RF) | Bayesian adaptive design, RDN vs sham (1:1) | 331 | Uncontrolled office and 24-hr BP, in the absence of antihypertensive drugs | Change in 24-hr SBP at 3 months | −4.7 (95% CI: −6.4 to −2.9) vs −0.6 mmHg (95% CI: −2.1 to 0.9); p = 0.0005 |
| RADIANCE-HTN TRIO, 202113 | Paradise (US) | RDN vs sham (1:1) | 136 | Uncontrolled office and daytime ambulatory BP on 3 antihypertensive drugs | Change in daytime ambulatory SBP at 2 months | −8.0 (IQR −16.4, 0.0) vs −3.0 mmHg (IQR −10.3, 1.8); p = 0.022 |
| REQUIRE, 202219 | Paradise (US) | RDN vs sham (1:1) | 143 | Uncontrolled office and 24-hr BP on ≥3 antihypertensive drugs | Change in daytime ambulatory SBP at 3 months | −6.6 (95% CI: −10.4 to −2.8) vs −6.5 mmHg (95% CI: −10.3 to −2.7); p = 0.971 |
BP: blood pressure; CI: confidence interval; IQR: interquartile ratio; RDN: renal denervation; RF: radiofrequency; SBP: systolic blood pressure; SSAHT: standardised stepped-care antihypertensive treatment; US: ultrasound
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