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NCT Number: NCT02642445

Renal Sympathetic Denervation From The Adventitia on Hypertension

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhengzhou university People's Hospital

Zhengzhou, Henan, 450000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Change from Baseline Systolic Blood Pressure at 6 months,12 months, 18 months

    Time frame: at 6 months,12 months,18 months

    The Change of Systolic Blood Pressure from Baseline to 6 months,12 months, 18 months

Secondary outcomes

  1. Change from Baseline Renin at 6 months,12 months, 18 months

    Time frame: at 6 months,12 months,18 months

    The Change of Renin from Baseline to 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

    The Change of aldosterone from Baseline to 6 months,12 months, 18 months

Sponsors and collaborators

Lead sponsor

Henan Institute of Cardiovascular Epidemiology

Other

Registry information

Official study title

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

Acronym: RSDAH

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Dec 30, 2015
Registry last updated
Nov 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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