A Clinical Study of the Paradise™ Renal Denervation System in Patients With Hypertension (RADIANCE-HTN DUO)

Launched by OTSUKA MEDICAL DEVICES CO., LTD. JAPAN · Apr 6, 2022

Keywords

ClinConnect Summary

The RADIANCE-HTN DUO clinical trial is investigating a new treatment method for high blood pressure (hypertension) using the Paradise™ Renal Denervation System. This system aims to help reduce blood pressure in patients who are already taking two different blood pressure medications but still struggle to manage their levels. In this study, some participants will receive the renal denervation treatment, while others will undergo a sham procedure (which means they won’t receive the actual treatment but will be treated the same way in other respects) to compare the effectiveness of both approaches.

To be eligible for this trial, participants should be adults who have been on two specific blood pressure medications for at least four weeks without any changes to their treatment. Their blood pressure must be measured at certain levels during preliminary visits to ensure they qualify. Participants can expect regular check-ups and monitoring throughout the study, and they will contribute to important research that could help improve treatment options for hypertension in the future. It's also important to note that certain health conditions and medications may exclude individuals from participating to ensure safety during the trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria :
• • Patients who have received antihypertensive treatment with two antihypertensive drugs (ARB/ACE inhibitor and Ca channel antagonist, either as a single agent or as a combination) for at least 4 weeks prior to obtaining consent, with no change in the type or dosage.
• • Patients with a mean seated office blood pressure of between 140 mmHg and 180 mmHg systolic and between 90 mmHg and 110 mmHg diastolic at screening visit.
• • Patients with a mean 24-hour ABPM (ambulatory blood pressure measurement) of between 130 mmHg and 170 mmHg systolic and between 80 mmHg and 105 mmHg diastolic at baseline visit
• • Exclusion Criteria
• • Lacks appropriate renal artery anatomy for renal denervation
• • Secondary hypertension other than sleep apnea
• • Type 1 diabetes mellitus or uncontrolled Type 2 diabetes
• • Any history of cerebrovascular event or severe cardiovascular event, within 6 months prior to consent
• • Repeated hospitalization for hypertensive crisis (twice or more) within 12 months prior to obtaining consent, or any hospitalization for hypertensive crisis within 3 months prior to obtaining consent
• • Patients prescribed to drugs that have antihypertensive effects for other chronic diseases, and the investigator considers that discontinuation of these drugs may pose a serious risk to health
• • Patients who are taking drugs known to affect blood pressure and the investigator judges that it is not possible to discontinue these drugs during the study period
• • Patients with a history of persistent or permanent atrial tachyarrhythmia
• • Patients with active implantable medical devices
• • Primary pulmonary hypertension
• • Patients with contraindications or unacceptable anaphylactic reactions or uncontrolled allergy to contrast media
• • Night shift workers
• • Pregnant, nursing or planning to become pregnant
• • Patients with any of the following central laboratory tests at screening
• • Plasma aldosterone/renin ratio greater than or equal to 200 and plasma aldosterone greater than or equal to 60 pg/ml
• • HbA1c greater than or equal to 8.0%
• • eGFR less than 40 mL/min/1.73m2