Status:
COMPLETED
Adrenal Artery Ablation Treats Primary Aldosteronism
Lead Sponsor:
Third Military Medical University
Conditions:
Primary Aldosteronism
Hypertension
Eligibility:
All Genders
30-60 years
Phase:
PHASE3
Brief Summary
Primary aldosteronism (PA) is one of the most common cause of endocrine and resistant hypertension. Current studies have shown that the activation of the renin-angiotensin-aldosterone system (RAAS) an...
Eligibility Criteria
Inclusion
- Primary Aldosteronis diagnosed by increased Renin ratio (ARR) and serum aldosterone levels ≥15 ng / dl, and confirmed by saline injection test or captopril inhibition test.
- Idiopathic aldosteronism, bilateral adrenal hyperplasia, and unilateral adrenal hyperplasia with no superior secretion confirmed with adrenal CT and adrenal venous blood (AVS).
- The patients was diagnosed with aldosteronoma or unilateral adrenal hyperplasia but refused to surgical excision.
- Signed informed consent and agreed to participate in this study.
Exclusion
- Aldosterone cancer.
- Hyperkalemia.
- Renal failure or the following history of nephropathy: serum creatinine 1.5 times higher than the upper limit; dialysis history; or nephrotic syndrome.
- Secondary hypertension except the primary aldosteronism.
- Adrenergic insufficiency.
- Heart failure with NYHA grade Ⅱ-Ⅳ grade or unstable angina, severe cardiovascular and cerebrovascular stenosis, myocardial infarction, intracranial aneurysm, stroke and other acute cardiovascular events.
- Acute infections, tumors and severe arrhythmias, psychiatric disorders, drugs or alcohol addicts.
- Liver dysfunction or the following history of liver disease: AST or ALT 2 times higher than the upper limit, liver cirrhosis, history of hepatic encephalopathy, esophageal variceal history or portal shunt history.
- Coagulation dysfunction.
- Pregnant women or lactating women.
- Participated in other clinical trials or admitted with other research drugs within 3 months prior to the trial.
- Any surgical or medical condition which can significantly alter the absorption, distribution, metabolism, or excretion of any study drug.
- Allergy or any contraindications for the study drugs, contrast agents and alcohol.
- Refused to sign informed consent
Key Trial Info
Start Date :
October 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2019
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT03398785
Start Date
October 1 2017
End Date
June 30 2019
Last Update
July 8 2019
Active Locations (1)
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1
The third hospital affiliated to the Third Military Medical University
Chongqing, Chongqing Municipality, China, 400042