Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06513676

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

As one of the causes of refractory secondary hypertension, primary aldosteronism is usually treated with drug therapy and adrenalectomy, but the therapeutic effect of these regimens is limited in some people. Adrenal vein blood collection is a method to identify the types of primary hyperaldosteronism by comparing the ratio of aldosterone in venous blood by selective catheterization into adrenal vein. Superselective adrenal artery embolization is a catheter-based percutaneous cavitary procedure in which ethanol is selectively injected into the adrenal artery to ablate part of the adrenal gland. Recently, it has been used as an alternative therapy for patients with unilateral aldosterone-producing adenomas as well as idiopathic hyperaldosteronism without obvious adenomas. This is a prospective, multicenter, randomized controlled study in Xinjiang to explore the potential of SAAE as a treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;

Exclusion criteria

  • 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;

Treatment and study plan

Primary outcomes

  1. Complete biochemical cure of PA

    Time frame: 6 months post intervention

    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)
  2. Complete clinical cure of PA

    Time frame: 6 months post intervention

    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).

Secondary outcomes

  1. Changes in ambulatory blood pressure and baseline blood pressure

    Time frame: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months

    24-hour ambulatory blood pressure and office systolic and diastolic pressure

  2. Change of the number of antihypertensive medications

    Time frame: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months

    Difference in the change of the number of antihypertensive medications

  3. Adverse events

    Time frame: Reported throughout the study period. Approximately 2 years

    Will be directly sought at each study visit through history and physical examination where appropriate Subjects will be encouraged to report between study visits and will have a mechanism to do so Will be classified by system, seriousness, causal relationship and expectedness according to the Common Terminology Criteria for Adverse Events v5.0 (CTCAE)

  4. Readmission rate

    Time frame: Reported throughout the study period. Approximately 2 years

    Readmission rate, defined as readmission for primary aldosteronism

  5. Change of blood electrolytes (K+, Na +)

    Time frame: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months

    Difference in the change of blood electrolytes (K+, Na + in mmol/L)

  6. Change of plasma aldosterone

    Time frame: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months

    Difference in the change of plasma aldosterone (pg/mL)

  7. Change of plasma cortisol

    Time frame: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months

    Difference in the change of plasma cortisol (nmol/L)

  8. Change of plasma renin measured

    Time frame: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months

    Difference in the change of plasma renin (pg/ml)

  9. Change of liver enzymes

    Time frame: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months

    Difference in the change of liver enzymes (ALT, AST in IU/L)

  10. Change of kidney function

    Time frame: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months

    Difference in the change of serum creatinine in umol/L

  11. Change of fasting blood glucose

    Time frame: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months

    Difference in the change of fasting blood glucose in mmol/L

  12. Change of lipids profiles

    Time frame: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months

    Difference in the change of lipids profiles (TC, HDL-C, LDL-C, TG) in mmol/L

  13. Change of 24-h urine microalbumin

    Time frame: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months

    Difference in the change of 24-h urine microalbumin (mg/L)

  14. Change of 24-h 24-h urine creatinine

    Time frame: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months

    Difference in the change of 24-h urine creatinine (umol/L)

Study contacts

Contact information is provided by the study sponsor or research team.

Xiang Xie

CONTACT

[email protected]

+869914366892

Sponsors and collaborators

Lead sponsor

Xinjiang Medical University

Other

Registry information

Official study title

The First Affiliated Hospital of Xinjiang Medical University

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Jul 22, 2024
Registry last updated
Jul 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.