Renal Sympathetic Denervation From The Adventitia on Hypertension

Henan Institute of Cardiovascular Epidemiology60 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Primary Aldosteronism Due to Aldosterone Producing Adenoma

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. . Renal artery diameter ≥4 mm and Length ≥20 mm; 2. . 18 years old ≤ age ≤ 70 years old; 3. . Specific diagnosis of adrenal adenoma and primary aldosteronism before the patients are enrolled in the study; 4. . 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) . 5. . 24 hours ambulatory blood pressure (SBP/DBP)≥140 and/or 90 mmHg; 6. . Estimated GFR (eGFR)≥45 ml/min / 1.73 m2. Exclusion Criteria: 1. . 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; 2. . 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; 3. . The patients with typeⅠdiabetes; 4. . Other serious organic disease; 5. . Participated in other clinical research.

Outcomes

Primary Outcomes

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

Time frame: at 6 months,12 months,18 months

Secondary Outcomes

Change from Baseline Renin at 6 months,12 months, 18 months

The Change of Renin from Baseline to 6 months,12 months, 18 months

Time frame: 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

Time frame: at 6 months,12 months,18 months

Renal Sympathetic Denervation From The Adventitia on Hypertension

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes