Adrenal Artery Ablation for Primary Aldosteronism

NCT ID: NCT03653845

Last Updated: 2018-08-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-01
• Study Completion Date: 2020-01-01

Brief Summary

Primary aldosteronism (PA) is one of the most common causes 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.

Conditions

Primary Aldosteronism; Hypertension

Keywords

Hypertension; Primary Aldosteronism; Ablation; Adrenal Gland

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intevention

Patients in this group will be treated with endovascular chemical ablation of adrenal glandp by endovascular injection of dehydrated alcohol. Sequenced antihypertensvie drugs with titrated dosage(amlodipine 5-10 mg/d ; terazosin 2-6mg/d) will be prescribed if home blood pressure (HBP) exceeds ≥160/100 mmHg.

Group Type: EXPERIMENTAL

Endovascular chemical Ablation of Adrenal Gland

Intervention Type: PROCEDURE

Patients in this group will be treated with partial ablation of adrenal gland by endovascular injection of dehydrated alcohol.

Sequenced antihypertensvie drugs with titrated dosage

Intervention Type: DRUG

Patients will be treated with different antihypertensive drugs in two groups.

Control

Patients in this group will be treated only with sequenced antihypertensvie drugs with titrated dosage(amlodipine 5mg/d→plus spironolactone 20 mg/d→plus spironolactone 40 mg/d→plus spironolactone 60 mg/d→→plus amlodipine 10 mg/ d →plus terazosin 2-6mg / d) if home blood pressure (HBP) exceeds ≥160/100 mmHg.

Group Type: ACTIVE_COMPARATOR

Sequenced antihypertensvie drugs with titrated dosage

Intervention Type: DRUG

Patients will be treated with different antihypertensive drugs in two groups.

Interventions

Endovascular chemical Ablation of Adrenal Gland

Patients in this group will be treated with partial ablation of adrenal gland by endovascular injection of dehydrated alcohol.

Intervention Type: PROCEDURE

Sequenced antihypertensvie drugs with titrated dosage

Patients will be treated with different antihypertensive drugs in two groups.

Intervention Type: DRUG

Eligibility Criteria

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 were 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 3 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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Third Military Medical University

OTHER

Sponsor Role: lead

Responsible Party

Zhiming Zhu

Director of the Department of Hypertension & Endocrinology, Daping Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The third hospital affiliated to the Third Military Medical University

Chongqing, Chongqing Municipality, China

Site Status: RECRUITING

The third hospital affiliated to the Third Military Medical University

Chongqing, , China

Site Status: RECRUITING

Countries

China

Facility Contacts

Hongbo He, MD.

Role: primary

Zhiming Zhu, MD, PhD

Role: primary

Other Identifiers

AAA-PA

Identifier Type: -

Identifier Source: org_study_id