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Renal Sympathetic Denervation From The Adventitia on Hypertension (RSDAH)

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ClinicalTrials.gov Identifier: NCT02642445
Recruitment Status : Recruiting
First Posted : December 30, 2015
Last Update Posted : March 12, 2020
Sponsor:
Information provided by (Responsible Party):
Chuanyu Gao, Henan Institute of Cardiovascular Epidemiology

Tracking Information
First Submitted Date  ICMJE December 19, 2015
First Posted Date  ICMJE December 30, 2015
Last Update Posted Date March 12, 2020
Study Start Date  ICMJE December 2016
Actual Primary Completion Date March 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 26, 2015)
Change from Baseline Systolic Blood Pressure at 6 months,12 months, 18 months [ Time Frame: at 6 months,12 months,18 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 31, 2015)
  • Change from Baseline Renin at 6 months,12 months, 18 months [ Time Frame: at 6 months,12 months,18 months ]
  • Change from Baseline aldosterone at 6 months,12 months, 18 months [ Time Frame: at 6 months,12 months,18 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 26, 2015)
Change from Baseline Renin and aldosterone at 6 months,12 months, 18 months [ Time Frame: at 6 months,12 months,18 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Renal Sympathetic Denervation From The Adventitia on Hypertension
Official Title  ICMJE Efficacy and Safety of Renal Sympathetic Denervation From The Adventitia on Hypertension in Patients With Primary Aldosteronism
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Primary Aldosteronism Due to Aldosterone Producing Adenoma
Intervention  ICMJE 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
Study Arms  ICMJE
  • Experimental: Renal Sympathetic Denervation
    Renal sympathetic Denervation are conducted from the adventitia of renal artery
    Intervention: Device: Renal Sympathetic Denervation
  • No Intervention: Control Group
    Renal Sympathetic Denervation are not conducted in control group.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 13, 2019)
56
Original Estimated Enrollment  ICMJE
 (submitted: December 26, 2015)
60
Estimated Study Completion Date  ICMJE May 31, 2020
Actual Primary Completion Date March 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lijie Zhu, master +86 15225080141 zhulijie7788@163.com
Contact: ChuanYu Gao, Dr. +86 13937165590 gaocy6802@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02642445
Other Study ID Numbers  ICMJE HenanICE201502
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chuanyu Gao, Henan Institute of Cardiovascular Epidemiology
Study Sponsor  ICMJE Henan Institute of Cardiovascular Epidemiology
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: ChuanYu Gao, Dr. Henan Institute of Cardiovascular Epidemiology
Principal Investigator: Dayi Hu, Dr. Henan Institute of Cardiovascular Epidemiology
PRS Account Henan Institute of Cardiovascular Epidemiology
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP