ReCor Medical announced today randomization of its 146th, and final, subject in the SOLO cohort of its RADIANCE-HTN study. RADIANCE-HTN, ReCor’s study of its Paradise Renal Denervation System in people with hypertension, involves two study cohorts: “SOLO” – whose subjects are removed from anti-hypertensive medication, and “TRIO” whose subjects are put on standardized medication. Both cohorts are randomized, blinded, sham-controlled, and powered independently for efficacy.
The RADIANCE-HTN 40 study centers – located in the US, France, Belgium, the Netherlands, Germany and the UK – enrolled 1,000 and randomized 165 study subjects in 2017. The final SOLO subject was randomized at Massachusetts General Hospital, under the lead of Joseph Garasic, MD, interventional cardiologist and Randall Zusman, MD, Director of the MGH Hypertension Clinic.
Completion of the SOLO cohort of RADIANCE marks the largest blinded, sham-controlled, randomized and powered clinical study of renal denervation in an “off-meds” study design. Lead enrollers were Yale Wang, MD, at the Minneapolis Heart Center; Florian Rader, MD at Cedars Sinai, Los Angeles; Melvin Lobo, MD, at St Bartholomew’s Hospital, London; and Joost Daemen, MD, at the Erasmus Heart Center, Rotterdam, NL.
“Leaders in the hypertension field understand that patients struggle to persevere with multi-drug regimens required to attain and maintain target blood pressure levels over their lifetimes. The completion of enrollment into the SOLO arm of RADIANCE-HTN is highly significant as this cohort represents the vast majority of hypertensive patients,” commentedMelvin Lobo, MD, Director of Barts BP Center of Excellence at St Bartholomew’s Hospital, London. “If SOLO proves positive, then there may be a pathway, with additional study, to a reduction of medications, increased longer-term therapeutic options, and improved blood pressure control for our patients.”
“The 40 RADIANCE-HTN study centers have reached major milestones in 2017: completion of the SOLO cohort of the study, and enrollment of 1,000 and randomization of 165 study subjects in one year. These are significant achievements, and testimony to the interest of hypertensive patients in new therapeutic options,” commented co-PI Laura Mauri, MD, of Brigham & Women’s Hospital in Boston. “The Paradise technology is unique in its circumferential ablation profile, the procedure is straightforward, and we look forward to understanding its performance in the SOLO group later this year.”
“ReCor is very pleased to have finished the SOLO cohort of RADIANCE-HTN in record time. It is a testimony to the interest of patients, and to the support of our study centers in the US and Europe,” commented Helen Reeve-Stoffer, ReCor Medical, VP Clinical Affairs. “Given the 60-day time point for the SOLO primary efficacy measure, ReCor anticipates outcome analysis and associated publications starting mid-year in 2018.”