Status:

RECRUITING

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

Lead Sponsor:

Third Military Medical University

Conditions:

Primary Aldosteronism

Hypertension

Eligibility:

All Genders

30-60 years

Phase:

NA

Brief Summary

Primary aldosteronism (PA) is one of the most common cause of endocrine and resistant hypertension. Current studies have shown that the activation of the renin-angiotensin-aldosterone system (RAAS) an...

Eligibility Criteria

Inclusion

  • 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 was diagnosed with aldosteronoma or unilateral adrenal hyperplasia but refused to surgical excision.
  • Signed informed consent and agreed to participate in this study.

Exclusion

  • 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 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.
  • 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

Key Trial Info

Start Date :

December 1 2019

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2025

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT04409431

Start Date

December 1 2019

End Date

December 1 2025

Last Update

August 20 2024

Active Locations (1)

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Page 1 of 1 (1 locations)

1

The third hospital affiliated to the Army Medical University

Chongqing, Chongqing Municipality, China, 400042