The Effect of Ablation Duration of Renal Denervation on Antihypertensive Efficacy

Korábbi kezelés

• Major surgery or traumatic injury within 1 month before enrollment; acute coronary syndrome within 6 months before enrollment; or planned surgery or cardiovascular intervention within the next 6 months.

Más betegség

• Secondary hypertension, including hypertension caused by primary aldosteronism, pheochromocytoma/paraganglioma, Cushing syndrome, hyperthyroidism, aortic coarctation, or renovascular disease.
• Allergy to contrast media.
• A history of deep vein thrombosis within 6 months.
• Stroke or transient ischemic attack (TIA) within 3 months.
• Severe peripheral vascular disease or an abdominal aortic aneurysm requiring surgical intervention.
• Severe valvular heart disease or a condition likely to require surgical valve replacement during the study period.
• A history of atrial fibrillation or multifocal atrial tachycardia within 6 months, or a history of pacemaker or implantable cardioverter-defibrillator (ICD) implantation.
• A serious comorbid condition that may affect study participation or survival, such as malignancy or AIDS.
• Acute or severe systemic infection.
• Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study.

Laborértékek

• A solitary kidney, a history of kidney transplantation, or an estimated glomerular filtration rate (eGFR) <40 mL/min/1.73 m².
• Type 1 diabetes mellitus or type 2 diabetes mellitus with HbA1c >8%.
• Significant bleeding tendency or hematologic disorders, including a platelet count <50 × 10⁹/L or an international normalized ratio (INR) >1.5.

Egyéb

• Pregnancy.
• Unilateral or bilateral renal artery anatomical abnormalities unsuitable for renal denervation, including renal artery stenosis >50%, renal artery aneurysm, renal artery dysplasia, or renal artery diameter <3 mm or >8 mm. Four radiofrequency ablations in the main renal artery or an accessory renal artery are not permitted.
• Orthostatic hypotension.

• Men or women aged 20 to 80 years, inclusive.
• A history of hypertension for at least 3 months.
• Clinic systolic blood pressure ≥150 mmHg and <180 mmHg, and/or clinic diastolic blood pressure ≥90 mmHg, together with a 24-hour mean systolic blood pressure ≥140 mmHg and <170 mmHg, as specified in the study protocol.
• Patients receiving 1 to 3 standard antihypertensive medications at baseline, or patients who cannot tolerate antihypertensive medications because of contraindications or adverse drug reactions.
• The participant or legally authorized representative is able to understand the study, and the participant voluntarily signs the written informed consent form.