RADIANCE-HTN CLINICAL TRIAL

 

RADIANCE-HTN is a multicenter, blinded, randomized (1:1), sham-controlled trial to evaluate the use of the Paradise Ultrasound Renal Denervation System to reduce ambulatory blood pressure in patients with mild-moderate hypertension (SOLO Cohort) and resistant hypertension (TRIO Cohort).  Both cohorts were individually powered for efficacy with a primary endpoint of daytime systolic ambulatory blood pressure (ABP) at 2 months (2M).

The study was conducted at over 50 centers in 7 countries (United States, United Kingdom, France, Germany, Netherlands, Belgium, and Poland), and 282 subjects were randomized.

Significant Blood Pressure Reductions Achieved in Patients
with Mild-Moderate and Resistant Hypertension in the Absence of and Presence of Anti-hypertensive Medication

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

Key Take-aways

The Paradise Ultrasound Renal Denervation System significantly lowered blood pressure in patients with mild-moderate hypertension and demonstrated:

The Paradise Ultrasound Renal Denervation System demonstrated safety, efficacy, and durability in patients with mild-moderate hypertension.

 

RADIANCE-HTN TRIO is an international, multicenter, blinded, randomized (1:1), sham controlled study to evaluate the use of the Paradise Ultrasound Renal Denervation System for patients resistant to medical hypertension treatment. This is the first of its kind study, where all patients were placed on a standardized triple combination anti-hypertensive therapy, then tested for sustained hypertension and randomized against a sham control.

Key Take-aways

The Paradise Ultrasound Renal Denervation System significantly lowered blood pressure in patients with resistant hypertension who were randomized and followed for 2 months while on a triple combination therapy, and demonstrated:

Azizi et al. Lancet. 2021. In press.
Kirtane. ACC 2021.

The Paradise Ultrasound Renal Denervation System significantly lowered blood pressure and demonstrated safety and efficacy in patients with resistant hypertension at 2 months.