Primary Aldosteronism: Superselective Embolization vs. Laparoscopic Endocrine Curative Therapy

NCT06513585 | Recruiting DMC

• 1 other identifier: 20240613
• Study Type: interventional
• Target: 570
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to compare the efficacy and safety of adrenalectomy and superselective adrenal artery embolization in a prospective, multicenter, randomized controlled study. To provide a new interventional alternative therapy for primary aldosteronism.

Conditions

Primary Aldosteronism; Suprarenalectomy; Super Selective Adrenal Artery Embolization

Outcome Measures

Primary Outcomes (2)

• Complete biochemical cure of PA

  Complete biochemical cure of PA, defined (whilst off medications that might alter serum potassium or the RAS) by both: Normalisation of serum potassium, and Normalisation of ARR, or Elevated ARR and i). Baseline PAC \<190pmol/L, or ii). Normal confirmatory test (as defined in the inclusion criteria)

  6 months post intervention

• Complete clinical cure of PA

  Complete clinical cure of PA, defined as normotension without antihypertensive medication

  6 months post intervention

Secondary Outcomes (14)

• Changes in ambulatory blood pressure and baseline blood pressure

  1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months

• Change of the number of antihypertensive medications

  1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months

• Adverse events

  Reported throughout the study period. Approximately 2 years

• Readmission rate

  Reported throughout the study period. Approximately 2 years

• Change of blood electrolytes (K+, Na +)

  1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months

Study Arms (2)

Superselective adrenal artery embolization group

EXPERIMENTAL

Superselective adrenal artery embolization for primary aldosteronism

Procedure: Superselective adrenal artery embolization or adrenalectomy

Adrenalectomy group

ACTIVE COMPARATOR

Adrenalectomy for primary aldosteronism

Procedure: Superselective adrenal artery embolization or adrenalectomy

Interventions

Superselective adrenal artery embolization or adrenalectomy PROCEDURE

Arm A underwent SAAE treatment, and arm B underwent laparoscopic adrenalectomy.

Also known as: Adrenalectomy

Adrenalectomy group; Superselective adrenal artery embolization group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-60
• Diagnosed with primary aldosteronism according to the 2016 Clinical guidelines of the International Endocrine Society
• Primary aldosteronism diagnosed according to international guidelines Unilateral disease by AVS or PET-CT criteria
• Patients and their family members signed informed consent and agreed to participate in the study

You may not qualify if:

• A history of severe hypersensitivity to contrast media
• Severe liver disease complications, such as thrombocytopenia, esophageal varices rupture bleeding, etc
• Renal insufficiency (serum creatinine \> 176mmol/L or estimated glomerular filtration rate \< min.1.73m2)
• Combined with other secondary hypertension, such as pheochromocytoma, hypercortisolism, renal vascular hypertension (such as renal artery stenosis), renin secretory tumor, renal parenchymatous hypertension, drug-induced hypertension (such as long-term use of glucocorticoids, contraceptives, estrogen, herbal medicines containing glycyrrhizin), pregnancy hypertension and other secondary hypertension
• Combined with genetic diseases: such as false aldosteronism (Liddle syndrome), Bartter syndrome, familial hypokalemia and hypomagnesia (Gitelman syndrome)
• Stroke, myocardial infarction and stent implantation occurred in the past 3 months
• Serious other diseases, such as heart dysfunction (grade IV), acute infections, autoimmune diseases, various malignant tumors, etc
• Participated in other clinical trials within the past 3 months
• Pregnant, breastfeeding, or planning a pregnancy
• Identify patients with alcohol allergy

Sponsors & Collaborators

• Xinjiang Medical University: lead
• First Affiliated Hospital of Xinjiang Medical University: collaborator

Study Sites (1)

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, 630000, China

RECRUITING

MeSH Terms

Conditions

Hyperaldosteronism

Interventions

Adrenalectomy

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Endocrine Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Ying-Ying Zheng, PhD

  1st affiliatted hospital of Xinjiang Medical University

  STUDY CHAIR

Central Study Contacts

Xiang Xie, PhD

CONTACT

+869914366892; xiangxie999@sina.com

Changjiang Deng

CONTACT

+869914366892; 1187229853@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Hypertension Department, Clinical Professor

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: July 22, 2024
• Study Start: August 1, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)