Study Finds Renal Denervation is a New Option for Patients with Hypertension
Jo Abraham, MD (Nephrology) is a co-principal investigator on the RADIANCE-HTN SOLO study that investigated renal denervation as a treatment for patients with hypertension.
Recently, ReCor Medical announced the Radiance Hypertension SOLO study meets primary efficacy endpoint. The study investigated whether an alternative technology using endovascular ultrasound renal denervation reduces ambulatory blood pressure in patients with hypertension in the absence of antihypertensive medications.
Laura Mauri, MD, co-principal investigator for the RADIANCE-HTN SOLO study discussed where renal denervation stands today during an interview at the 2018 EuroPCR conference.
The study concluded that endovascular ultrasound renal denervation significantly reduced blood pressure in hypertensive patients. Furthermore, findings from the study provide a solid platform to move forward with a pivotal study for FDA approval of the Paradise System, for the treatment of hypertension.
For the study, 803 patients were screened for eligibility and 146 were randomized to undergo renal denervation or sham procedure. Compared with a sham procedure, endovascular ultrasound renal denervation reduced ambulatory blood pressure at 2 months in patients with combined systolic–diastolic hypertension in the absence of medications.
Some of the key takeaways from the study include:
- Low risk patient population; few baseline co-morbidities; average age 54 years; approximately 40% female; average BMI approximately 29
- ITT Primary Endpoint Results - daytime ABP
- Treatment BP reduction of -8.2mmHg versus -2.2mmHg sham
- Difference of -6.3 mmHg (p< 0.001)
- PP Primary Endpoint Results - daytime ABP
- Treatment BP reduction of -8.2mmHg versus -0.1 mmHg sham
- Difference of -8.2 mmHg (P<0.001)
- Significant differences also found between treatment and sham in 24-hr; office and home BP (ITT)
- 24% of treated patients achieved control (24-hr ABPM <130/80 mmHg) versus 3% sham without restarting antihypertensive medications
- Short procedures - an average of 5.4 ablations: 38 seconds ablation time and 141 cc of contrast.
- No major safety events reported
For additional findings, the Lancet Journal published, “Endovascular ultrasound renal denervation to treat hypertension (RADIANCE-HTN-SOLO): a multicenter, international, single-blind, randomized, sham-controlled trial.”
At this time, the study is recruiting for the resistant hypertension arm of the study. You can email Jo Abrahim, MD; or call study coordinator, Sarah Naegle, at 801-585-1897 for more information.