Effects of Adrenal Artery Ablation and Adrenalectomy in Patients With Primary Aldosteronism

NCT04269928 | Completed

• 1 other identifier: Quadruple A -PA
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

Primary aldosteronism (PA) is the main cause of secondary hypertension, affecting 5-15% of the general hypertensive population. Early diagnosis and treatment are of crucial importance as patients with PA are more susceptible to cardiovascular and cerebrovascular morbidity and mortality than blood-pressure-matched hypertensive patients. Current guidelines indicate that mineralocorticoid receptor (MR) antagonists and laparoscopic adrenalectomy are the principal treatments for PA.Laparoscopic adrenalectomy is recommended for patients with aldosteronoma or unilateral adrenal hyperplasia. During the past two decades, catheter-based arterial embolization or computed tomography (CT)-guided radiofrequency thermogenesis have been used for aldosteronomas treatment. Although these procedures are claimed to be effective for treatment of aldosteronomas, the evidence comes mostly from case reports or small series. In addition, some PA patients refuse surgery and are intolerant of the adverse effects of MR antagonists; others have persistence of PA after adrenelectomy, but respond poorly to MR antagonists. An alternative therapy is needed in such cases. In recent years, adrenal artery ablation has also been used to treat primary aldosteronism, which can reduce the level of aldosterone and blood pressure, but its efficacy and safety are not clear. To confirm the effect of adrenal artery ablation on blood pressure, RAAS system and blood potassium, the researchers conducted a parallel control clinical study of patients with primary aldosteronism (Aldosteronoma).

Conditions

Primary Aldosteronism; Hypertension

Keywords

Primary Aldosteronism; Hypertension; Adrenal Artery Ablation; Adrenalectomy

Outcome Measures

Primary Outcomes (1)

• Change of office systolic and diastolic pressure

  Change of office systolic and diastolic pressure between the intervention and control group at the end of the study (24 weeks)

  52 weeks (End of Trial)

Secondary Outcomes (12)

• Change of 24-h average systolic blood pressure

  52 weeks (End of Trial)

• Change of 24-h average diastolic blood pressure

  52 weeks (End of Trial)

• Change of home systolic and diastolic pressure

  52 weeks (End of Trial)

• Change of anti-hypertensive regimen

  52 weeks (End of Trial)

• Change of blood electrolytes（serum potassium and natrium in mmol/L）

  52 weeks (End of Trial)

Study Arms (2)

Adrenal Artery Ablation

Patients in the intervention group will be treated with ablation of adrenal gland by endovascular injection of dehydrated alcohol

Procedure: Endovascular chemical ablation of adrenal gland

Adrenalectomy

Patients in this group will be treated with unilateral laparoscopic adrenalectomy

Interventions

Endovascular chemical ablation of adrenal gland PROCEDURE

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

Adrenal Artery Ablation

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Chinese

You may qualify if:

• Primary aldosteronis diagnosed by increased aldosterone-to-renin ratio (ARR) and serum aldosterone levels ≥15 ng / dl, and confirmed by saline injection test or captopril inhibition test.
• Aldosteronoma had lateralization by adrenal venous sampling (AVS) and confirmed with CT
• Signed informed consent and agreed to participate in this study.

You may not qualify if:

• 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 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.
• Allergy or any contraindications for contrast agents and alcohol.
• Refused to sign informed consent

Sponsors & Collaborators

• Third Military Medical University: lead

Study Sites (1)

The third hospital affiliated to the Army Medical University

Chongqing, Chongqing Municipality, 400042, China

Location

MeSH Terms

Conditions

Hyperaldosteronism; Hypertension

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the department of Hypertension & Endocrinology, Daping Hospital

Study Record Dates

• First Submitted: February 12, 2020
• First Posted: February 17, 2020
• Study Start: January 19, 2016
• Primary Completion: December 30, 2019
• Study Completion: June 1, 2021
• Last Updated: March 22, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)