Renal Sympathetic Denervation From The Adventitia on Hypertension (RSDAH)

Efficacy and Safety of Renal Sympathetic Denervation From The Adventitia on Hypertension in Patients With Primary Aldosteronism

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.

Study Overview

• Status: Completed
• Conditions: Primary Aldosteronism Due to Aldosterone Producing Adenoma
• Intervention / Treatment: Device: Renal Sympathetic Denervation

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450000
      • Zhengzhou university People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Renal Sympathetic Denervation; Renal sympathetic Denervation are conducted from the adventitia of renal artery	Device: 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
No Intervention: Control Group; Renal Sympathetic Denervation are not conducted in control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Renin at 6 months,12 months, 18 months	The Change of Renin from Baseline to 6 months,12 months, 18 months	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	at 6 months,12 months,18 months

Collaborators and Investigators

• Sponsor: Henan Institute of Cardiovascular Epidemiology
• Investigators: Principal Investigator: ChuanYu Gao, Dr., Henan Institute of Cardiovascular Epidemiology; Principal Investigator: Dayi Hu, Dr., Henan Institute of Cardiovascular Epidemiology

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (Actual): March 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: December 19, 2015
• First Submitted That Met QC Criteria: December 26, 2015
• First Posted (Estimate): December 30, 2015

Study Record Updates

• Last Update Posted (Actual): November 3, 2020
• Last Update Submitted That Met QC Criteria: October 30, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Renal sympathetic denervation;hypertension
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Adrenocortical Hyperfunction; Adrenal Gland Diseases; Hypertension; Adenoma; Hyperaldosteronism
• Other Study ID Numbers: HenanICE201502

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No