Renal Sympathetic Denervation From The Adventitia on Hypertension

NCT02642445 | Completed DMC

• 1 other identifier: HenanICE201502
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Aldosteronism Due to Aldosterone Producing Adenoma

Keywords

Renal sympathetic denervation;hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  at 6 months,12 months,18 months

• Change from Baseline aldosterone at 6 months,12 months, 18 months

  at 6 months,12 months,18 months

Study Arms (2)

Renal Sympathetic Denervation

EXPERIMENTAL

Renal sympathetic Denervation are conducted from the adventitia of renal artery

Device: Renal Sympathetic Denervation

Control Group

NO INTERVENTION

Renal Sympathetic Denervation are not conducted in control group.

Interventions

Renal Sympathetic Denervation 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

Renal Sympathetic Denervation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Renal artery diameter ≥4 mm and Length ≥20 mm;
• 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) .
• hours ambulatory blood pressure (SBP/DBP)≥140 and/or 90 mmHg;
• Estimated GFR (eGFR)≥45 ml/min / 1.73 m2.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Henan Institute of Cardiovascular Epidemiology: lead

Study Sites (1)

Zhengzhou university People's Hospital

Zhengzhou, Henan, 450000, China

Location

Study Officials

• ChuanYu Gao, Dr.

  Henan Institute of Cardiovascular Epidemiology

  PRINCIPAL INVESTIGATOR

• Dayi Hu, Dr.

  Henan Institute of Cardiovascular Epidemiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 19, 2015
• First Posted: December 30, 2015
• Study Start: December 1, 2016
• Primary Completion: March 31, 2019
• Study Completion: December 31, 2019
• Last Updated: November 3, 2020

Record last verified: 2020-10

Locations

CN (1)