Actively Recruiting

Age: 30Years - 65Years
All Genders
NCT07137364

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

Led by Third Military Medical University · Updated on 2025-08-22

350

Participants Needed

1

Research Sites

208 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The goal of this observational study is to learn about the optimal dose of spironolactone treatment and the long-term outcomes on cardiovascular and cerebrovascular events in patients with lateralized PA who are unwilling to undergo surgery. The main question it aims to answer is: 1. What is the long-term effect of spironolactone treatment for lateralized PA? 2. What is the optimal dose of spironolactone treatment for the relief of renin inhibition in patients with lateralized PA? Participants will receive spironolactone treatment as part of their regular medical care for more than 12 months, and their clinical indicators, including blood pressure, biochemical remission, cardiovascular and renal damage, and the incidence of cardiovascular and cerebrovascular events, will be analyzed.

CONDITIONS

Official Title

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

Who Can Participate

Age: 30Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female, aged 30 to 65 years
  • Diagnosed with primary aldosteronism confirmed by positive screening and saline suppression tests, and lateralization confirmed by adrenal venous sampling
  • 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
  • Patients with unilateral aldosterone-producing adenoma who decline surgery or non-adenoma unilateral PA confirmed by adrenal venous sampling
  • Provided written informed consent to participate in the study
Not Eligible

You will not qualify if you...

  • Hyperkalemia
  • Renal impairment or history of kidney disease: serum creatinine above 1.5 times upper limit of normal, dialysis, or nephrotic syndrome
  • Other confirmed secondary hypertension causes such as pheochromocytoma, Cushing's syndrome, thyroid or parathyroid disorders, acromegaly, renovascular disease, aortic disorders, chronic alcoholism, or drug dependence
  • Adrenal insufficiency
  • Heart failure classified as NYHA class II-IV or stroke
  • Acute infection, cancer, severe arrhythmia, psychiatric disorders, or drug/alcohol abuse
  • Significant liver dysfunction or history of liver disease: AST or ALT more than twice upper limit of normal, cirrhosis, hepatic encephalopathy, esophageal varices, or portosystemic shunt
  • Pregnancy or lactation
  • Participation in another clinical trial in the past 3 months
  • Inability to complete follow-up
  • Refusal to provide informed consent

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Daping Hospital, Army Medical Center of PLA

Chongqing, Chongqing Municipality, China, 400042

Actively Recruiting

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Research Team

Z

Zhencheng Yan, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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