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

NCT07137364 | Recruiting DMC

• 1 other identifier: SPIRO in PA
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

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 PA who are unwilling to undergo surgery. The main question it aims to answer is:

1. 1.What is the long-term effect of spironolactone treatment for lateralized PA?
2. 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

Primary Aldosteronism; Hypertension

Outcome Measures

Primary Outcomes (2)

• Change of systolic blood pressure

  This study will gain insight into the effect of spironolactone treatment on systolic blood pressure. The systolic blood pressure (mmHg) is measured before and after spironolactone treatment, respectively. The changes of systolic blood pressure are analyzed after the spironolactone treatment.

  From enrollment to spironolactone treatment at 12 months.

• Change of diastolic blood pressure

  This study will gain insight into the effect of spironolactone treatment on diastolic blood pressure. The diastolic blood pressure (mmHg) is measured before and after spironolactone treatment, respectively. The changes of diastolic blood pressure are analyzed after the spironolactone treatment.

  From enrollment to spironolactone treatment at 12 months.

Secondary Outcomes (16)

• Change of anti-hypertensive regimen

  From enrollment to spironolactone treatment at 12 months.

• Change of serum potassium

  From enrollment to spironolactone treatment at 12 months.

• Change of plasma aldosterone

  From enrollment to spironolactone treatment at 12 months.

• Change of plasma renin

  From enrollment to spironolactone treatment at 12 months.

• Change of fasting plasma glucose

  From enrollment to spironolactone treatment at 12 months.

Study Arms (1)

Unilateral primary aldosteronism group

The patients are diagnosed with unilateral primary aldosteronism based on adrenal venous sampling diagnosis, they will treated with spironolactone according to their own condition

Drug: spironolactone

Interventions

spironolactone DRUG

The patients receive spironolactone treatment based on their conditions

Also known as: Aldactone

Unilateral primary aldosteronism group

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Chinese

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Third Military Medical University: lead

Study Sites (1)

Daping Hospital, Army Medical Center of PLA

Chongqing, Chongqing Municipality, 400042, China

RECRUITING

MeSH Terms

Conditions

Hyperaldosteronism; Hypertension

Interventions

Spironolactone

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Zhiming Zhu, MD

  Department of Hypertension and Endocrinology, Daping Hospital, Army Medical University

  STUDY CHAIR

Central Study Contacts

Zhencheng Yan, MD

CONTACT

+8613983656682; zhenchengyan@sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the department of Hypertension & Endocrinology, Daping Hospital

Study Record Dates

• First Submitted: August 3, 2025
• First Posted: August 22, 2025
• Study Start: May 1, 2022
• Primary Completion: December 1, 2025
• Study Completion: April 30, 2026
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)