CompletedNot Applicable

Renal Sympathetic Denervation From The Adventitia on Hypertension

China60 participantsStarted 2016-12

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

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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;

What they're measuring

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

Timeframe: at 6 months,12 months,18 months

Trial details

NCT IDNCT02642445

SponsorHenan Institute of Cardiovascular Epidemiology

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-03-31

View on ClinicalTrials.gov More Primary Aldosteronism Due to Aldosterone Producing Adenoma trials