"Real-world Assessment of BP Control in Patients With Hypertension by the Netrod RDN System" - REACH-RDN

Official title

Main Objective: To Evaluate the Long-term Safety and Efficacy of Using the Netrod-RDN Renal Artery Radiofrequency Ablation System in Treating Patients With Refractory Hypertension and Those With Hypertension Who Are Intolerant to Medication in the Real-world Setting

Overview

This study is an observational one, collecting real-world data generated in routine clinical treatment. The Netrod-RDN renal artery radiofrequency ablation system (including the renal artery radiofrequency ablation device and the disposable mesh renal artery radiofrequency ablation catheter) produced and provided by Shanghai Meiliweiye Medical Technology Co., Ltd. was used to perform percutaneous renal denervation (RDN) on patients with refractory hypertension and drug intolerance in the real world. Refractory hypertension is defined as patients whose blood pressure remains uncontrolled despite taking three or more antihypertensive drugs (including one diuretic) for more than three months; drug intolerance refers to patients who have contraindications to drugs or cannot tolerate drug administration due to adverse drug reactions.

Detailed description

All the subjects who were enrolled and received RDN treatment were followed up until 36 months after the surgery. Blood pressure was measured and the antihypertensive effect was evaluated at regular intervals at 7 days after RDN or before discharge (whichever came first), 30 days (±7 days) after the surgery, 3 months (±14 days), 6 months (±30 days), 12 months (±30 days), 24 months (±30 days), and 36 months (±30 days) during the follow-up. Dynamic safety data monitoring was conducted for the subjects throughout the entire study process.

Interventions

• Device Percutaneous nephrolysis combined with sympathetic nerve ablation (RDN) procedure
  The disposable mesh renal artery radiofrequency ablation catheter is a spiral-arranged 6-point mesh system. Once The use of a meshed renal artery radiofrequency ablation catheter in combination with a dedicated renal artery radiofrequency ablation device delivers radiofrequency energy to the inner wall of the renal artery, generating appropriate high temperatures to damage or partially damage the renal sympathetic nerves. This device has real-time temperature, power and impedance monitoring func

Primary outcome measures

• Change from Baseline in 24-hour Ambulatory Blood Pressure (including both systolic and diastolic BP) [Time frame: Time Frame: Baseline to Month 6 post-procedure.]

Secondary outcome measures (10)

• Change from Baseline in Office Blood Pressure (including both systolic and diastolic BP) [Time frame: Baseline to Day 7 or hospital discharge (whichever occurs first), and Months 1, 3, 6, 12, 24, and 36 post-procedure.]
• Change from Baseline in 24-hour Ambulatory Blood Pressure (including both systolic and diastolic BP) [Time frame: Baseline to 3, 12, 24, and 36 months post-procedure]
• Change from Baseline in Home Blood Pressure (including both systolic and diastolic BP) [Time frame: Time Frame: Baseline to Months 1, 3, 6, 12, 24, and 36 post-procedure.]
• Change from Baseline in Antihypertensive Medication Load (calculated based on the dosage and types of antihypertensive agents). [Time frame: Baseline to Day 7 or hospital discharge (whichever occurs first), and Months 1, 3, 6, 12, 24, and 36 post-procedure.]
• Proportion of Participants Achieving Blood Pressure Targets (Office, Home, and 24-hour Ambulatory; including both systolic and diastolic BP) [Time frame: At the same assessment time points as the above BP measurements (office, home, and 24-hour ambulatory BP).]
• 24-hour Time in Target Range for Ambulatory Blood Pressure (percentage of time meeting daytime <135/85 mmHg and nighttime <120/70 mmHg thresholds) [Time frame: Months 6, 12, and 36 post-procedure.]
• Change from Baseline in SF-12 Health-Related Quality of Life Score (for heart failure subgroup only) [Time frame: Baseline to Months 12 and 36 post-procedure.]
• Change from Baseline in Six-Minute Walk Distance (meters; heart failure subgroup only) [Time frame: Baseline to Months 6, 12, 24, and 36 post-procedure.]
• Periprocedural major adverse event (MAE) rate [Time frame: Baseline to 30 days post-procedure]
• Safety event rates [Time frame: Baseline to Month 36 post-procedure]

Eligibility criteria

Inclusion criteria

• (1) Patients who have already used or are planning to use the Netrod-RDN renal artery radiofrequency ablation system for RDN surgery;
• (2) Patients understand the requirements and treatment of this clinical study, agree to follow the requirements of this clinical study for follow-up, and sign the informed consent form before undergoing any special examinations and operations related to the study.

Exclusion criteria

• Patients with contraindications for RDN surgery and/or those who the researchers consider unsuitable for RDN or who do not wish to participate in this study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

China · 1 center

• Capital Medical University Beijing Anzhen Hospital — Beijing

Identifiers

NCT: NCT07273877 · MLWY-S240801

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗