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Renal Sympathetic Denervation From The Adventitia on Hypertension (RSDAH)

Primary Purpose

Primary Aldosteronism Due to Aldosterone Producing Adenoma

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Renal Sympathetic Denervation
Sponsored by
Henan Institute of Cardiovascular Epidemiology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Aldosteronism Due to Aldosterone Producing Adenoma focused on measuring Renal sympathetic denervation;hypertension

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Zhengzhou university People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Renal Sympathetic Denervation

Control Group

Arm Description

Renal sympathetic Denervation are conducted from the adventitia of renal artery

Renal Sympathetic Denervation are not conducted in control group.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change from Baseline Renin at 6 months,12 months, 18 months
The Change of Renin from Baseline to 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

Full Information

First Posted
December 19, 2015
Last Updated
October 30, 2020
Sponsor
Henan Institute of Cardiovascular Epidemiology
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1. Study Identification

Unique Protocol Identification Number
NCT02642445
Brief Title
Renal Sympathetic Denervation From The Adventitia on Hypertension
Acronym
RSDAH
Official Title
Efficacy and Safety of Renal Sympathetic Denervation From The Adventitia on Hypertension in Patients With Primary Aldosteronism
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
December 2016 (undefined)
Primary Completion Date
March 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henan Institute of Cardiovascular Epidemiology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Aldosteronism Due to Aldosterone Producing Adenoma
Keywords
Renal sympathetic denervation;hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Renal Sympathetic Denervation
Arm Type
Experimental
Arm Description
Renal sympathetic Denervation are conducted from the adventitia of renal artery
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Renal Sympathetic Denervation are not conducted in control group.
Intervention Type
Device
Intervention Name(s)
Renal Sympathetic Denervation
Intervention Description
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
Primary Outcome Measure Information:
Title
Change from Baseline Systolic Blood Pressure at 6 months,12 months, 18 months
Description
The Change of Systolic Blood Pressure from Baseline to 6 months,12 months, 18 months
Time Frame
at 6 months,12 months,18 months
Secondary Outcome Measure Information:
Title
Change from Baseline Renin at 6 months,12 months, 18 months
Description
The Change of Renin from Baseline to 6 months,12 months, 18 months
Time Frame
at 6 months,12 months,18 months
Title
Change from Baseline aldosterone at 6 months,12 months, 18 months
Description
The Change of aldosterone from Baseline to 6 months,12 months, 18 months
Time Frame
at 6 months,12 months,18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: . Renal artery diameter ≥4 mm and Length ≥20 mm; . 18 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) . . 24 hours ambulatory blood pressure (SBP/DBP)≥140 and/or 90 mmHg; . Estimated GFR (eGFR)≥45 ml/min / 1.73 m2. Exclusion Criteria: . 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ChuanYu Gao, Dr.
Organizational Affiliation
Henan Institute of Cardiovascular Epidemiology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dayi Hu, Dr.
Organizational Affiliation
Henan Institute of Cardiovascular Epidemiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhengzhou university People's Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450000
Country
China

12. IPD Sharing Statement

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Renal Sympathetic Denervation From The Adventitia on Hypertension

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