Spironolactone with antihypertensives for unilateral primary aldosteronism

Efficacy of Spironolactone Combined With Antihypertensive Drugs in Patients With Primary Aldosteronism

This project will try different doses of spironolactone together with usual blood-pressure medicines in adults with lateralized primary aldosteronism who decline surgery to see if it relieves renin suppression and lowers long-term cardiovascular risks.

Quick facts

• Study type: Observational
• Enrollment: 350 (estimated)
• Ages: 30 Years to 65 Years
• Sex: All
• Sponsor: Third Military Medical University (other)
• Locations: 1 site (Chongqing, Chongqing Municipality)
• Trial ID: NCT07137364 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 30–65 with AVS-confirmed unilateral primary aldosteronism, hypertension by office or ambulatory criteria, who decline surgery and can provide informed consent are ideal candidates.

Not a fit: Patients with hyperkalemia, significant renal impairment, other secondary causes of hypertension, or those planning adrenalectomy are unlikely to benefit from this observational medical-therapy protocol.

Why it matters

Potential benefit: If successful, the study could clarify the optimal spironolactone dose that reduces renin suppression and may lower long-term cardiovascular risk for patients with unilateral PA who choose not to have surgery.

How similar studies have performed: Retrospective cohorts have suggested higher long-term cardiovascular risk with spironolactone-treated PA compared with adrenalectomy and that higher doses may be needed to correct low renin, but large prospective trials are lacking.

Eligibility criteria

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 this trial is running

Chongqing, Chongqing Municipality

• Daping Hospital, Army Medical Center of PLA — Chongqing, Chongqing Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Zhencheng Yan, MD

Conditions: Primary Aldosteronism, Hypertension