Renal Sympathetic Denervation From The Adventitia on Hypertension
- Conditions
- Primary Aldosteronism Due to Aldosterone Producing Adenoma
- Interventions
- Device: Renal Sympathetic Denervation
- Registration Number
- NCT02642445
- Lead Sponsor
- Henan Institute of Cardiovascular Epidemiology
- Brief Summary
Renal sympathetic denervation from the intima of renal arteries has become an important method for the treatment of resistant hypertension, but renal sympathetic nerve are mainly located in the adventitia, and there is no report about renal sympathetic denervation from the renal adventitia. Primary aldosteronism is an important factor of secondary hypertension, tumor aldosterone in unilateral adrenal can increase the concentration of plasma aldosterone, in some patients blood pressure control is still not desirable after resection of tumor aldosterone. This study intends to conduct renal sympathetic denervation ablation from the adventitia to observe its efficacy and safety on blood pressure of patients with primary aldosterone.
- Detailed Description
Renal sympathetic denervation from the intima of renal arteries has become an important method for the treatment of resistant hypertension, but renal sympathetic nerve are mainly located in the adventitia, and there is no report about renal sympathetic denervation from the renal adventitia. Primary aldosteronism is an important factor of secondary hypertension, tumor aldosterone in unilateral adrenal can increase the concentration of plasma aldosterone, in some patients blood pressure control is still not desirable after resection of tumor aldosterone.
This study intends to conduct renal sympathetic denervation ablation（RDN）from the adventitia to observe its efficacy and safety on blood pressure of patients with primary aldosterone.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- . Renal artery diameter ≥4 mm and Length ≥20 mm;
- . 18 years old ≤ age ≤ 70 years old;
- . Specific diagnosis of adrenal adenoma and primary aldosteronism before the patients are enrolled in the study;
- . Clinic systolic blood pressure≥160 mmHg and/or diastolic blood pressure≥100 mmHg (patients with type 2 diabetes: clinic systolic blood pressure≥150 mmHg and/or diastolic blood pressure≥95 mmHg) .
- . 24 hours ambulatory blood pressure (SBP/DBP)≥140 and/or 90 mmHg;
- . Estimated GFR (eGFR)≥45 ml/min / 1.73 m2.
- . Renal artery abnormalities include: either side renal arterial blood flow mechanics or anatomical obvious stenosis (≥50% ); Underwent renal artery balloon angioplasty or inserting a stent; Renal artery anatomy apparently is unusual to insert catheter;
- . Cardiovascular instability includes: myocardial infarction in six months, unstable angina or cerebrovascular disease; Thrombus or unstable plaques in the arteries with extensive atherosclerosis; Hemodynamic apparently change in patients with heart valve disease;
- . The patients with typeⅠdiabetes;
- . Other serious organic disease;
- . Participated in other clinical research.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Renal Sympathetic Denervation Renal Sympathetic Denervation Renal sympathetic Denervation are conducted from the adventitia of renal artery
- Primary Outcome Measures
Name Time Method Change from Baseline Systolic Blood Pressure at 6 months,12 months, 18 months at 6 months,12 months,18 months The Change of Systolic Blood Pressure from Baseline to 6 months,12 months, 18 months
- Secondary Outcome Measures
Name Time Method Change from Baseline Renin at 6 months,12 months, 18 months at 6 months,12 months,18 months The Change of Renin from Baseline to 6 months,12 months, 18 months
Change from Baseline aldosterone at 6 months,12 months, 18 months at 6 months,12 months,18 months The Change of aldosterone from Baseline to 6 months,12 months, 18 months
Trial Locations
- Locations (1)
Zhengzhou university People's Hospital
🇨🇳Zhengzhou, Henan, China