Statin Combined with Amlodipine Treats Primary Aldosteronism

Phase 4

Recruiting

• Conditions: Primary Aldosteronism; Statin; Mineralocorticoid Receptor Antagonist; Hypertension
• Interventions: Drug: Simvastatin combined with Amlodipine besylate; Drug: Simvastatin combined with Spironolactone and Amlodipine besylate.; Drug: Amlodipine besylate combined Spironolactone

• Registration Number: NCT06523465
• Lead Sponsor: Third Military Medical University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-17
• Study First Submitted QC: 2024-07-24
• Study First Posted: 2024-07-26
• Study Start: 2024-09-10
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-22
• Primary Completion: 2025-12-30
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• Clinical diagnosis of primary aldosteronism

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
changes in 24-hour urinary aldosterone levels	6 month	24 hours urine are collected at baseline and 6 months after treatment to measure 24-hour urinary aldosterone， and compare between groups and within groups(pmol/24h)
changes in plasma aldosterone levels	6 month	blood samples are collected at baseline and 6 months after treatment to measure plasma aldosterone levels， and compare between groups and within groups (pg/ml)

Secondary Outcome Measures

Name	Time	Method
changes in serum potassium levels	6 month	blood samples are collected at baseline and 6 months after treatment to measure serum potassium levels， and compare between groups and within groups (mmol/L)
changes in office blood pressure and home blood pressure	6 month	Record office blood pressure at baseline and at follow-up after medical treatment (mmHg), and compare between groups and within groups
changes in serum renin level	6 month	blood samples are collected at baseline and 6 months after treatment to measure serum renin levels, and compare between groups and within groups (mU/L)
changes in plasma cholesterol levels	6 month	blood samples are collected at baseline and 6 months after treatment to measure plasma cholesterol levels， and compare between groups and within groups (mmol/L)
changes in blood glucose	6 month	blood samples are collected at baseline and 6 months after treatment to measure blood glucose， and compare between groups and within groups (mmol/L)

Trial Locations

Locations (1)

No. 10 Changjiang River Branch, Yuzhong District，Chongqing, China; 🇨🇳 Chongqing, Chongqing, China