Renal Sympathetic Denervation From The Adventitia on Hypertension

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy and Safety of Renal Sympathetic Denervation From The Adventitia on Hypertension in Patients With Primary Aldosteronism

Conditions
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Primary Aldosteronism Due to Aldosterone Producing Adenoma

Intervention / Treatment
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* Device: Renal Sympathetic Denervation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: . 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. Exclusion Criteria: . 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Renal Sympathetic Denervation<br>Renal sympathetic Denervation are conducted from the adventitia of renal artery | Device: Renal Sympathetic Denervation<br>* We applied a ablation catheter for discrete radiofrequency ablations of 8 W or less and lasting up to 2 min each to obtain up to four-six ablations separated both longitudinally and rotationally from the adventitia<br>|
| No Intervention: Control Group<br>Renal Sympathetic Denervation are not conducted in control group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Systolic Blood Pressure at 6 months,12 months, 18 months | The Change of Systolic Blood Pressure from Baseline to 6 months,12 months, 18 months | at 6 months,12 months,18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Renin at 6 months,12 months, 18 months | The Change of Renin from Baseline to 6 months,12 months, 18 months | at 6 months,12 months,18 months | 
| Change from Baseline aldosterone at 6 months,12 months, 18 months | The Change of aldosterone from Baseline to 6 months,12 months, 18 months | at 6 months,12 months,18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Renal sympathetic denervation;hypertension