A Randomized Trial of Six-Channel RF Ablation System for Renal Denervation in Uncontrolled Hypertension and Chronic Kidney Disease

Korábbi kezelés

• Subjects with a solitary kidney, prior renal transplantation, or requiring dialysis.
• Prior renal artery intervention or prior renal denervation.
• Major surgery or trauma within 1 month before enrollment; acute coronary syndrome within 6 months; or planned surgery or cardiovascular interventional therapy within the next 6 months.
• History of ventricular fibrillation, polymorphic ventricular tachycardia within six months, or prior implantation of an implantable cardioverter-defibrillator (ICD) or pacemaker.
• Concomitant severe diseases that may interfere with study participation or affect survival, such as malignancy or AIDS.
• Known drug or alcohol dependence, difficulty understanding the study protocol, inability or unwillingness to comply with follow-up requirements.
• Current or planned participation in other clinical trials of drugs or medical devices (post-marketing registry studies permitted).

Más betegség

• Other secondary hypertension not related to kidney disease (such as primary aldosteronism, pheochromocytoma/paraganglioma, Cushing's syndrome, thyroid disease, aortic coarctation, monogenic hypertension, renovascular hypertension, etc.).
• Allergic to contrast agents.
• Type 1 diabetes mellitus.
• Primary pulmonary arterial hypertension.
• History of bleeding diathesis and haematological disorders or coagulopathy
• History of thromboembolic event within 6 months.
• History of stroke or transient ischemic attack (TIA) within 6 months.
• Severe peripheral arterial disease or unstable abdominal aortic aneurysm.
• Severe valvular heart disease or anticipated need for surgical valve replacement during the study period.
• NYHA Class III/IV heart failure at screening or hospitalization for exacerbation of chronic heart failure within the past six months.
• Acute or severe systemic infection.
• Other conditions deemed unsuitable for participation by the investigator.

Laborértékek

• Acute kidney injury (AKI) within 4 weeks before enrollment or acute kidney disease ，AKI: ≥50% increase in serum creatinine within 7 days, or absolute increase ≥0.3 mg/dL (≥26.5 μmol/L) within 48 hours, or oliguria (<0.5 mL·kg-¹·h-¹ for ≥6 hours).

Egyéb

• Pregnant or breastfeeding, or planning pregnancy during the study.
• Renal artery anatomy unsuitable for ablation (e.g., ≥50% stenosis, renal artery aneurysm, malformation, renal artery diameter <3 mm, or treatable segment length <20 mm).
• Orthostatic hypotension.
• Severe hepatic dysfunction.

• Male or female, aged 18 to 65 years, inclusive, at the time of consent;
• Hypertensive subjects who have been taking 2 types of standardized antihypertensive drugs continuously and stably for at least 4 weeks, with office systolic blood pressure still ≥150 mmHg and <180 mmHg, and 24-hour ambulatory mean systolic blood pressure (24h SBP) ≥135 mmHg and <170 mmHg; or who have been taking ≥3 types of standardized antihypertensive drugs continuously and stably for at least 4 weeks, with office systolic blood pressure ≥140 mmHg and <180 mmHg, and 24h SBP ≥130 mmHg and <170 mmHg;
• Estimated glomerular filtration rate (eGFR) ≥20 mL/min/1.73m² and <60 mL/min/1.73m²;
• The subject or his/her legal representative fully understands the content of the informed consent form for this trial and voluntarily signs the written informed consent form.