Statin Combined with Amlodipine Treats Primary Aldosteronism (STOP-PA)

Third Military Medical University

Status and phase: Enrolling; Phase 4

Conditions: Statin; Hypertension; Mineralocorticoid Receptor Antagonist; Primary Aldosteronism

Treatments: Drug: Simvastatin combined with Spironolactone and Amlodipine besylate.; Drug: Amlodipine besylate combined Spironolactone; Drug: Simvastatin combined with Amlodipine besylate

Study type: Interventional

Funder types: Other

Identifiers

NCT06523465

STOP-PA

Details and patient eligibility

About

The drug treatment for primary aldosteronism (PA) is limited and difficult to improve long-term cardiovascular outcomes. This study plans to enroll patients with primary aldosteronism and randomly divide into 3 groups: scheme 1: Statin combined with amlodipine besylate, scheme 2: Statin combined with Spironolactone and Amlodipine besylate. scheme 3: Amlodipine besylate combined with Spironolactone , to observe the changes in plasma aldosterone level, 24-hour urinary aldosterone, blood pressure, and long-term cardiovascular risk.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of primary aldosteronism

Exclusion criteria

• Allergy to drugs in this study
• Pregnancy
• Severe liver and kidney dysfunction
• Mental illness

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 3 patient groups

Simvastatin combined with Amlodipine besylate

Experimental group

Description:

after 1:1 randomization, 60 patients with primary aldosteronism were treated with Simvastatin combined with Amlodipine besylate for 6 months

Treatment:

Drug: Simvastatin combined with Amlodipine besylate

Simvastatin combined with Spironolactone and Amlodipine besylate.

Experimental group

Description:

after 1:1 randomization, 60 patients with primary aldosteronism were treated with Simvastatin combined with Spironolactone and Amlodipine besylate for 6 months

Treatment:

Drug: Simvastatin combined with Spironolactone and Amlodipine besylate.

Amlodipine besylate combined with Spironolactone

Experimental group

Description:

after 1:1 randomization, 60 patients with primary aldosteronism were treated with Amlodipine besylate combined with Spironolactone for 6 months

Treatment:

Drug: Amlodipine besylate combined Spironolactone