Renal Sympathetic Denervation From The Adventitia on Hypertension

NCT ID: NCT02642445

Last Updated: 2020-11-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2019-12-31

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.

Conditions

Primary Aldosteronism Due to Aldosterone Producing Adenoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Renal Sympathetic Denervation

Renal sympathetic Denervation are conducted from the adventitia of renal artery

Group Type: EXPERIMENTAL

Renal Sympathetic Denervation

Intervention Type: DEVICE

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

Control Group

Renal Sympathetic Denervation are not conducted in control group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Renal Sympathetic Denervation

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Henan Institute of Cardiovascular Epidemiology

OTHER

Sponsor Role: lead

Responsible Party

Chuanyu Gao

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

ChuanYu Gao, Dr.

Role: PRINCIPAL_INVESTIGATOR

Henan Institute of Cardiovascular Epidemiology

Dayi Hu, Dr.

Role: PRINCIPAL_INVESTIGATOR

Henan Institute of Cardiovascular Epidemiology

Locations

Zhengzhou university People's Hospital

Zhengzhou, Henan, China

Countries

China

Other Identifiers

HenanICE201502

Identifier Type: -

Identifier Source: org_study_id