Adrenal Artery Ablation Treats Primary Aldosteronism

Third Military Medical University

Status and phase

Completed

Phase 3

Conditions

Hypertension

Primary Aldosteronism

Treatments

Procedure: Endovascular chemical Ablation of Adrenal Gland

Study type

Interventional

Funder types

Other

Identifiers

NCT03398785

Triple A-PA

Details and patient eligibility

About

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) and the increased sympathetic nerve activity in the central or local tissue are the key mechanisms of high blood pressure and its organ damages.

The classical method for diagnosis of primary aldosteronism depends on the detection of peripheral venous blood aldosterone level, which is incapable of accurate positioning diagnosis. On the other hand, the current guidelines recommend that surgery and aldosterone receptor inhibitors were the only treatment for primary aldosteronism. However, only about 35% of aldosterone tumors and a small part of unilateral adrenal hyperplasia can be treated by surgery. More than 60% of idiopathic aldosteronism and bilateral adrenal hyperplasia need long-term drug therapy. However, long-term aldosterone inhibitor treatment may also cause hyperkalemia, male breast hyperplasia, female hirsutism and other adverse reactions.

Therefore, the investigators proposed that endovascular chemical partial ablation of the adrenal gland can lower the aldosterone level, reduce the blood pressure and recover the potassium metabolism balance. In order to confirm the above effects, the investigators conduct an open, prospective, positive controlled study in patients with primary aldosteronism patients (including aldosterone, idiopathic aldosteronism and adrenal hyperplasia). The effects on blood pressure, blood electrolytes, adrenal hormones, metabolic indexes, target organ damages were observed to explore the efficacy and safety of the endovascular ablation of the adrenal gland in the treatment of primary aldosteronism.

Enrollment

66 patients

Sex

All

Ages

30 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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