To Evaluate the Safety and Efficacy of a Single-Use IVUS Ablation for Primary Hypertension

Official title

A Prospective, Multicenter, Blinded, Randomized Controlled Clinical Trial Evaluating the Safety and Efficacy of a Single-Use Intravascular Ultrasound Ablation Catheter and Ultrasound Ablation System in the Treatment of Primary Hypertension

Overview

This is a prospective, multicenter, blinded, randomized controlled clinical trial designed to evaluate the safety and efficacy of a single-use intravascular ultrasound ablation catheter and ultrasound ablation system in the treatment of primary hypertension.

Detailed description

This trial adopts a prospective, multicenter, randomized controlled design to validate the safety and efficacy of a single-use intravascular ultrasound ablation catheter and ultrasound ablation system in the treatment of primary hypertension. Subjects who signed the informed consent form will enter the screening phase and undergo a run-in period for 4-week of standardized medication regimen. Specifically, their current antihypertensive treatment will be uniformly replaced with a combination of an angiotensin II receptor blocker (ARB) and calcium channel blocker (CCB) (Valsartan/Amlodipine 80:5 mg) or a triple combination of ARB/CCB (Valsartan/Amlodipine 80:5 mg) plus a diuretic (Hydrochlorothiazide 12.5mg) . If the subject's office systolic blood pressure (SBP) ≥180 mmHg or diastolic blood pressure (DBP) ≥110 mmHg during the run-in period, the investigator may adjust the medication and restart a run-in period of ≥28 days. Blood pressure will be re-evaluated, and subjects failed to meet the inclusion criteria after adjustment will be excluded.

Subjects meeting the inclusion criteria and not violating exclusion criteria will be randomized in a 2:1 ratio to either the treatment group or the control group. The treatment group will undergo intravascular ultrasound ablation therapy, while the control group will only undergo renal artery angiography. Both groups will maintain the standardized medication regimen for 6 months post-procedure (if a subject's office SBP exceeds 180 mmHg or drops below 110 mmHg in three consecutive measurements spaced 1 hour apart, the investigator may adjust the medication and record their blood pressure before the adjustment).

The primary efficacy endpoint is the change in 24-hour average ambulatory systolic blood pressure at 6 months post-procedure. Results will be analyzed using a superiority testing hypothesis to demonstrate that the treatment group achieves significantly greater reduction in 24-hour mean ambulatory systolic blood pressure compared to the control group at 6-month follow-up. During follow-up, office blood pressure, 24-hour ambulatory blood pressure, medication usage, safety events, and adverse events will be recorded for both groups.

Interventions

• Procedure Intravascular Ultrasound Ablation Therapy
  The single-use intravascular ultrasound ablation catheter is used in conjunction with the ultrasound ablation device to remove renal sympathetic nerves. Standardized medication regimen.
• Procedure Renal Artery Angiography
  Only undergo renal artery angiography. Standardized medication regimen.

Primary outcome measures

• Change in 24-hour average ambulatory systolic blood pressure (SBP) [at 6 months post-procedure] [Time frame: From baseline to 6 months]

Secondary outcome measures (8)

• Change in Daytime/Nighttime Average Ambulatory Systolic Blood Pressure (SBP) [Time frame: 1 Month, 2 Months, and 6 Months Post-Procedure]
• Change in 24-Hour/Daytime/Nighttime Average Ambulatory Diastolic Blood Pressure (DBP) [Time frame: 1 Month, 2 Months, and 6 Months Post-Procedure]
• Change in 24-Hour Average Ambulatory Systolic Blood Pressure (SBP) [Time frame: 1 Month and 2 Months Post-Procedure]
• Change in Office Systolic Blood Pressure [Time frame: 1 Month, 2 Months, and 6 Months Post-Procedure]
• Change in Office Diastolic Blood Pressure [Time frame: 1 Month, 2 Months, and 6 Months Post-Procedure]
• Achievement Rate of Target Office Systolic Blood Pressure [Time frame: 1 Month, 2 Months, and 6 Months Post-Procedure]
• Composite Index of Antihypertensive Medication Use [Time frame: 1 Month, 2 Months, and 6 Months Post-Procedure]
• Proportion of Subjects with ≥5 mmHg Reduction in 24-Hour Average Ambulatory Systolic Blood Pressure [Time frame: 6 Months Post-Procedure]

Eligibility criteria

Inclusion criteria

• Aged ≥18 years and ≤75 years, regardless of gender.
• Documented history of primary hypertension.
• Stable use of at least two antihypertensive medications for a minimum of 4 consecutive weeks prior to randomization, specifically requiring a combination of an angiotensin II receptor blocker (ARB) and a calcium channel blocker (CCB) or a triple combination of ARB/CCB plus a diuretic agent . After at least 4 consecutive weeks of screening, blood pressure must meet the following criteria:

• Office systolic blood pressure (SBP) ≥150 mmHg and <180 mmHg;
• Office diastolic blood pressure (DBP) ≥90 mmHg;
• 24-hour ambulatory systolic blood pressure ≥135 mmHg and <170 mmHg.
• Patients who can understand the purpose of the trial, voluntarily participate and sign the informed consent form, and are willing to comply with clinical follow-up.

Exclusion criteria

• Unsuitable Renal Artery Anatomy for Treatment

• Main renal artery diameter <4 mm or length <20 mm.
• Accessory renal artery diameter ≥ 2 mm and <4 mm.
• Renal artery stenosis >50% in the main renal artery.
• Renal artery aneurysm, fibromuscular dysplasia, or severe calcification.
• Presence of a renal artery stent.
• Single kidney.
• Estimated Glomerular Filtration Rate (eGFR) <45 mL/min/1.73 m².
• Diagnosis of Type 1 Diabetes Mellitus.
• Orthostatic Hypotension.
• Recent Vascular Events:Acute myocardial infarction, unstable angina, syncope, or cerebrovascular accident within 3 months prior to signing the informed consent form.
• Suspected Secondary Hypertension.
• Respiratory Support:a) Requirement for long-term oxygen support or mechanical ventilation (excluding nocturnal respiratory support for sleep apnea).
• Prior Renal Artery Denervation Procedure.
• Life Expectancy <1 Year.
• Pregnancy, Lactation, or Plans to Become Pregnant Within 6 Months (for Females); Males Planning to Conceive Within 6 Months.
• Current Participation in Another Clinical Trial Without Completion of the Primary Endpoint.
• Allergy to Contrast Agents.
• Other Reasons Deemed by the Investigator to Make the Subject Unsuitable for Participation (e.g., Poor Compliance).

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

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

China · 18 centers

• Beijing Anzhen hospital , Capital Medical University — Beijing
• China-Japan Friendship Hospital — Beijing
• Peking University First Hospital — Beijing
• Beijing Jishuitan Hospital Affiliated to Capital Medical University — Beijing
• Beijing Tsinghua Changgung Hospital — Beijing
• The Second Affiliated Hospital Chongqing Medical University — Chongqing
• The First Affiliated Hospital of Xiamen University — Xiamen
• The Second Hospital of Lanzhou University — Lanzhou
• … and 10 more centers

Identifiers

NCT: NCT07051811 · LPCTP-2021-004(CT)

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗