Spironolactone with antihypertensives for unilateral primary aldosteronism

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective observational study of patients with AVS-confirmed unilateral primary aldosteronism who choose medical therapy rather than adrenalectomy. Participants will receive spironolactone as part of routine care for more than 12 months and be followed for blood pressure, biochemical markers including renin, cardiovascular and renal damage, and the occurrence of cardiovascular and cerebrovascular events. The study aims to identify the spironolactone dose that best relieves renin suppression while monitoring safety issues such as hyperkalemia and endocrine side effects. Data will be collected at Daping Hospital (Army Medical Center of PLA) in Chongqing and analyzed to link dose, biochemical remission, and long-term outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Male or female, aged 30\~65 years.
2. PA patients with positive screening tests and saline suppression tests, and with AVS to determine lateralization. These patients have hypertension defined as office blood pressure ≥ 140/90 mmHg, or 24-hour ambulatory blood pressure showing average ≥ 130/80 mmHg, daytime blood pressure ≥ 135/85 mmHg, or nighttime blood pressure ≥ 120/70 mmHg.
3. Patients with unilateral aldosterone-producing adenoma who decline surgery, or patients with non-adenoma, unilateral PA confirmed by AVS and meeting the above PA-related hypertension criteria.
4. Provision of written informed consent to participate in the study.

Exclusion Criteria:

1. Hyperkalemia.
2. Renal impairment or have history of renal disease: serum creatinine \> 1.5 × upper limit of normal (ULN), dialysis, or nephrotic syndrome.
3. Other confirmed secondary hypertension: pheochromocytoma, Cushing's syndrome, thyroid disorders, parathyroid disorders, acromegaly, renovascular disease, aortic disorders, chronic alcoholism, or drug dependence, etc.
4. Adrenal insufficiency.
5. Heart failure with NYHA class II-IV or stroke.
6. Acute infection, malignancy, severe arrhythmia, psychiatric disorders, or drug/alcohol abuse.
7. Significant hepatic dysfunction or have history of liver disease: AST or ALT \> 2 × ULN, cirrhosis, hepatic encephalopathy, esophageal varices or portosystemic shunt.
8. Pregnancy or lactation.
9. Participation in another clinical trial within the past 3 months.
10. Inability to complete follow-up.
11. Refusal to provide informed consent.

Where it's running

• Daping Hospital, Army Medical Center of PLA
  Chongqing, Chongqing Municipality, China Recruiting

Study contacts

• Study coordinator: Zhencheng Yan, MD
• Email: zhenchengyan@sina.com
• Phone: +8613983656682

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.