Recor
Recor is a new noninvasive renal denervation treatment that’s being studied in patients with uncontrolled hypertension. It is a safe and effective procedure that has no known side effects. However, it should be used cautiously in patients with liver disease. There are other risks as well, including adrenal insufficiency and reduced production of cortisol.
ReCor’s noninvasive renal denervation treatment has no side effects
A study conducted by ReCor Medical has found no significant differences in 24-hour blood pressure in patients undergoing renal denervation with the ReCor device. Researchers also found no increased risks or side effects compared to the placebo group. Researchers presented the results of the study in the journal Hypertension Research. It was also presented at the annual meeting of the Japanese Society of Hypertension.
Early studies examining renal denervation in the treatment of resistant hypertension showed significant blood pressure reduction. These findings encouraged interest in the procedure and the rapid development of the technology. However, early studies comparing the ReCor treatment with a sham treatment failed to show a significant reduction in BP.
The RADIANCE-HTN trial analyzed ReCor’s noninvasive renal denerval treatment compared to a sham procedure. The RADIANCE-HTN trial involved two different cohorts: the SOLO cohort and the Trio cohort, both with uncontrolled hypertension. Each group was independently powered to detect a difference between the two treatments.
It is currently being studied in a pivotal trial in patients with uncontrolled hypertension
A pivotal trial has been conducted to assess the efficacy of recor in the treatment of uncontrolled hypertension. The RADIANCE-II trial is a randomized, sham-controlled clinical trial in which 224 patients with mild to moderate uncontrolled hypertension were randomized. The primary efficacy endpoint is a difference in daytime ambulatory systolic blood pressure compared to a sham procedure.
The study was able to detect a significant difference between groups of patients with hypertension. Patients were randomized to either a single-agent treatment or a triple-combination medication. The triple-combination medication increased medication adherence and improved the treatment of a cohort of patients with resistant hypertension.
The trial has received financial support from CVRx, a medical device company based in Minneapolis. The study’s investigators have received research grant support from the company and are consultants or advisors to CVRx. Dr. Bakris is an investigator for Relapysa, a consultant to Abbott, and a member of the board of the American Society of Hypertension. Dr. Schafer has a financial conflict of interest involving her consulting with the company.
Although there are a few limitations to recor’s use, its efficacy in patients with resistant hypertension remains undetermined. The current device requires a vascular surgical cut-down in an operating room, but future versions could allow for percutaneous implantation. Other targets under investigation include targeted splanchnic denervation and carotid body ablation. Regardless of the mechanism of action, sustained blood pressure reduction would represent a major advance for the cardiology field.
The study enrolled 1965 patients from 22 countries. Most were from Europe and North America. However, a smaller proportion were from Asia and Australia. The study’s results are based on an intention-to-treat analysis, which included all subjects who were randomized in the trial. It is important to note that some patients were unblinded for the first six months.
It should be used with caution in patients with liver disease
Recor should be used with caution in patients suffering from liver disease because it can lead to liver damage. This is especially true if patients with liver disease take certain medications. Drugs with liver-damaging effects are usually labeled with warnings about this potential problem. Nevertheless, some patients may not display any symptoms of liver damage. This is why a blood test may be helpful to detect liver damage before symptoms occur.
