Primary Aldosteronism Due to Aldosterone Producing Adenoma
Conditions
Keywords
Renal sympathetic denervation;hypertension
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.
Interventions
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
Sponsors
Henan Institute of Cardiovascular Epidemiology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline Systolic Blood Pressure at 6 months,12 months, 18 months | at 6 months,12 months,18 months | The Change of Systolic Blood Pressure from Baseline to 6 months,12 months, 18 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline Renin at 6 months,12 months, 18 months | 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 | at 6 months,12 months,18 months | The Change of aldosterone from Baseline to 6 months,12 months, 18 months |
Countries
China
Outcome results
None listed