Renal Sympathetic Denervation From The Adventitia on Hypertension (RSDAH)

Henan Institute of Cardiovascular Epidemiology

Status: Completed

Conditions: Primary Aldosteronism Due to Aldosterone Producing Adenoma

Treatments: Device: Renal Sympathetic Denervation

Study type: Interventional

Funder types: Other

Identifiers

NCT02642445

HenanICE201502

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Renal Sympathetic Denervation

Experimental group

Description:

Renal sympathetic Denervation are conducted from the adventitia of renal artery

Treatment:

Device: Renal Sympathetic Denervation

Control Group

No Intervention group

Description:

Renal Sympathetic Denervation are not conducted in control group.