Safety and Efficacy of Renal Denervation for Untreated Grade I Hypertension: a Pilot Study

Korábbi kezelés

• 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.

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.
• 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

• Subjects with a solitary kidney, prior renal transplantation, or requiring dialysis or eGFR<40mL/min/1.73m2。

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.

• Male or female, aged 18 to 65 years inclusive
• Hypertension duration longer than 3 months
• Hypertensive subjects who have been stopped taking antihypertensive drugs continuously and stably for at least 4 weeks or who do not take antihypertensive drugs , with office systolic/diastolic blood pressure still ≥140/90 mmHg and <160/100 mmHg, and 24-hour ambulatory mean systolic /diastolic pressure ≥130/80 mmHg and <140/90 mmHg;
• 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.