Super Selective Adrenal Artery Embolization for Primary Aldosteronism: a Prospective Cohort Study(SAAE-PA)

NCT06513676 | Recruiting DMC

• 1 other identifier: 240528-09
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study was to evaluate the efficacy and safety of adrenal vein blood extraction for primary aldosteronism classification and adrenal artery embolization in the treatment of primary aldosteronism, to provide new evidence plan for the diagnosis and treatment of primary aldosteronism, and to promote the development of adrenal artery embolization as a new treatment for primary aldosteronism.

Conditions

Primary Aldosteronism; Super Selective Adrenal Arterial 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: 1. Normalisation of serum potassium, and 2. Normalisation of ARR, or 3. 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 These criteria have been defined in the international consensus PASO statement8, which has become the established yardstick by which PA cure is judged. In this, normotension is defined, in accordance with the European Society of Hypertension guidelines22, as \<140/80 in the office, \<135/85 at home or daytime ambulatory monitoring and \<130/80 for 24h ambulatory blood pressure monitoring (24hABPM).

  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 (3)

Super selective adrenal artery embolization

SAAE for primary aldosteronism

adrenectomy

Surgery to remove part of the adrenal gland

Standard drug therapy

Drug treatment of primary aldosteronism

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Hypertensive patients were willing to participate and then hospitalized for further evaluation. Antihypertensive medications that affect the renin-angiotensin-aldosterone system were stopped for two weeks, diuretics and MRA were withdrawn for at least 4 weeks before ARR testing. Hypertensive patients were prescribed with verapamil and/or terazosin based on Endocrine Society Clinical Practice Guideline. Patients with positive aldosterone-to-renin ratio underwent one of the following confirmatory tests: saline infusion test or captopril inhibition test. Adrenal CT scan and adrenal venous sampling (AVS) were performed for subtype classification of the PA. The PA patients were counseled on the various treatment options, including surgery, medications, and adrenal artery ablation.

You may qualify if:

• Age 18-60 years old;
• Primary hyperaldosteronism was diagnosed in strict accordance with the 2016 International Endocrine Society clinical guidelines;
• Refusal of medication due to adverse reactions, refusal of adrenal resection due to surgical risk, or persistent hyperaldosteronism and cortical insufficiency after adrenal resection;
• The patients and their families were introduced in detail to all the current treatment methods for primary aldosteronism, and the adrenal artery embolization was voluntarily accepted;

You may not qualify if:

• A history of severe hypersensitivity to contrast media;
• There are serious complications of liver disease, such as thrombocytopenia, esophageal variceal 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, estrogens, herbs containing glycyrrhizin), pregnancy hypertension and other secondary hypertension;
• Hereditary diseases: such as false aldosteronism (Liddle syndrome), Bartter syndrome, familial hypokalemia and hypomagnesemia (Gitelman syndrome);
• Cerebral apoplexy, myocardial infarction and stent implantation occurred in the past 3 months;
• Serious other basic, such as heart dysfunction (grade IV), acute infection, autoimmune diseases, various malignant tumors and so on;
• Participated in other clinical trials within the past 3 months;
• Individual pregnancy, nursing or planning pregnancy;

Sponsors & Collaborators

• Xinjiang Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, 630000, China

RECRUITING

MeSH Terms

Conditions

Hyperaldosteronism

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases

Central Study Contacts

Xiang Xie

CONTACT

+869914366892; xiangxie999@sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Xiangxie, MD,Professor, The First Affiliated Hospital Of XinJiang Medicial University

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: July 22, 2024
• Study Start: April 15, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2028
• Last Updated: July 23, 2024

Record last verified: 2024-06

Locations

CN (1)