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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 : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Chuanyu Gao, Henan Institute of Cardiovascular Epidemiology

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.

Condition or disease Intervention/treatment Phase
Primary Aldosteronism Due to Aldosterone Producing Adenoma Device: Renal Sympathetic Denervation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Renal Sympathetic Denervation From The Adventitia on Hypertension in Patients With Primary Aldosteronism
Study Start Date : December 2016
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019


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.



Primary Outcome Measures :
  1. Change from Baseline Systolic Blood Pressure at 6 months,12 months, 18 months [ Time Frame: at 6 months,12 months,18 months ]

Secondary Outcome Measures :
  1. Change from Baseline Renin at 6 months,12 months, 18 months [ Time Frame: at 6 months,12 months,18 months ]
  2. Change from Baseline aldosterone at 6 months,12 months, 18 months [ Time Frame: at 6 months,12 months,18 months ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02642445


Contacts
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Contact: Lijie Zhu, master +86 15225080141 zhulijie7788@163.com
Contact: ChuanYu Gao, Dr. +86 13937165590 gaocy6802@163.com

Locations
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China, Henan
Zhengzhou university People's Hospital Recruiting
Zhengzhou, Henan, China, 450000
Contact: ChuanYu Gao, Dr.    +86 13937165590    gaocy6802@163.com   
Sponsors and Collaborators
Henan Institute of Cardiovascular Epidemiology
Investigators
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Principal Investigator: ChuanYu Gao, Dr. Henan Institute of Cardiovascular Epidemiology
Principal Investigator: Dayi Hu, Dr. Henan Institute of Cardiovascular Epidemiology

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Responsible Party: Chuanyu Gao, Principal Investigator, Henan Institute of Cardiovascular Epidemiology
ClinicalTrials.gov Identifier: NCT02642445     History of Changes
Other Study ID Numbers: HenanICE201502
First Posted: December 30, 2015    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chuanyu Gao, Henan Institute of Cardiovascular Epidemiology:
Renal sympathetic denervation;hypertension
Additional relevant MeSH terms:
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Adenoma
Hypertension
Hyperaldosteronism
Vascular Diseases
Cardiovascular Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases