Status:
RECRUITING
Efficacy of Spironolactone Combined With Antihypertensive Drugs in Patients With Primary Aldosteronism
Lead Sponsor:
Third Military Medical University
Conditions:
Primary Aldosteronism
Hypertension
Eligibility:
All Genders
30-65 years
Brief Summary
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...
Detailed Description
Primary aldosteronism (PA) is one of the most common causes of endocrine and treatment-resistant hypertension. Current guidelines suggest that surgery and aldosterone receptor antagonists (MRAs), such...
Eligibility Criteria
Inclusion
- Male or female, aged 30\~65 years.
- 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.
- 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.
- Provision of written informed consent to participate in the study.
Exclusion
- Hyperkalemia.
- Renal impairment or have history of renal disease: serum creatinine \> 1.5 × upper limit of normal (ULN), dialysis, or nephrotic syndrome.
- Other confirmed secondary hypertension: pheochromocytoma, Cushing's syndrome, thyroid disorders, parathyroid disorders, acromegaly, renovascular disease, aortic disorders, chronic alcoholism, or drug dependence, etc.
- Adrenal insufficiency.
- Heart failure with NYHA class II-IV or stroke.
- Acute infection, malignancy, severe arrhythmia, psychiatric disorders, or drug/alcohol abuse.
- Significant hepatic dysfunction or have history of liver disease: AST or ALT \> 2 × ULN, cirrhosis, hepatic encephalopathy, esophageal varices or portosystemic shunt.
- Pregnancy or lactation.
- Participation in another clinical trial within the past 3 months.
- Inability to complete follow-up.
- Refusal to provide informed consent.
Key Trial Info
Start Date :
May 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 30 2026
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT07137364
Start Date
May 1 2022
End Date
April 30 2026
Last Update
August 22 2025
Active Locations (1)
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1
Daping Hospital, Army Medical Center of PLA
Chongqing, Chongqing Municipality, China, 400042