Renal Sympathetic Denervation From The Adventitia on Hypertension

Primary Aldosteronism Due to Aldosterone Producing Adenoma Clinical Trial

— RSDAH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02642445
• Other study ID #: HenanICE201502
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Est. completion date: December 31, 2019

Study information

• Verified date: October 2020
• Source: Henan Institute of Cardiovascular Epidemiology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 31, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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 type?diabetes;

4. . Other serious organic disease;

5. . Participated in other clinical research.

Related Conditions & MeSH terms

• Adenoma
• Hyperaldosteronism
• Hypertension
• Primary Aldosteronism Due to Aldosterone Producing Adenoma

Intervention

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

Locations

Country	Name	City	State
China	Zhengzhou university People's Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Henan Institute of Cardiovascular Epidemiology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Systolic Blood Pressure at 6 months,12 months, 18 months	The Change of Systolic Blood Pressure from Baseline to 6 months,12 months, 18 months	at 6 months,12 months,18 months
Secondary	Change from Baseline Renin at 6 months,12 months, 18 months	The Change of Renin from Baseline to 6 months,12 months, 18 months	at 6 months,12 months,18 months
Secondary	Change from Baseline aldosterone at 6 months,12 months, 18 months	The Change of aldosterone from Baseline to 6 months,12 months, 18 months	at 6 months,12 months,18 months