Clinical trial NCT02642445: Renal Sympathetic Denervation From The Adventitia on Hypertension
Official title: Efficacy and Safety of Renal Sympathetic Denervation From The Adventitia on Hypertension in Patients With Primary Aldosteronism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Aldosteronism Due to Aldosterone Producing Adenoma
Keywords: Renal sympathetic denervation;hypertension
Lead sponsor: Henan Institute of Cardiovascular Epidemiology
Sponsor class: OTHER
First posted: 2015-12-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline Systolic Blood Pressure at 6 months,12 months, 18 months
timeFrame: at 6 months,12 months,18 months
Secondary outcomes:
measure: Change from Baseline Renin at 6 months,12 months, 18 months
timeFrame: at 6 months,12 months,18 months
measure: Change from Baseline aldosterone at 6 months,12 months, 18 months
timeFrame: at 6 months,12 months,18 months
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Zhengzhou university People's Hospital
state: Henan
Study officials:
affiliation: Henan Institute of Cardiovascular Epidemiology
name: ChuanYu Gao, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Henan Institute of Cardiovascular Epidemiology
name: Dayi Hu, Dr.
role: PRINCIPAL_INVESTIGATOR
References: