Statin Combined with Amlodipine Treats Primary Aldosteronism

NCT ID: NCT06523465

Last Updated: 2024-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-10

Study Completion Date

2026-09-30

Brief Summary

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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

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Conditions

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Primary Aldosteronism Statin Mineralocorticoid Receptor Antagonist Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Simvastatin combined with Amlodipine besylate

Intervention Type DRUG

6-month treatment of Simvastatin combined with 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

Group Type EXPERIMENTAL

Simvastatin combined with Spironolactone and Amlodipine besylate.

Intervention Type DRUG

6-month treatment of Simvastatin combined with Spironolactone and Amlodipine besylate.

Amlodipine besylate combined with Spironolactone

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

Group Type EXPERIMENTAL

Amlodipine besylate combined Spironolactone

Intervention Type DRUG

6-month treatment of Amlodipine besylate combined with Spironolactone

Interventions

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Simvastatin combined with Amlodipine besylate

6-month treatment of Simvastatin combined with Amlodipine besylate

Intervention Type DRUG

Simvastatin combined with Spironolactone and Amlodipine besylate.

6-month treatment of Simvastatin combined with Spironolactone and Amlodipine besylate.

Intervention Type DRUG

Amlodipine besylate combined Spironolactone

6-month treatment of Amlodipine besylate combined with Spironolactone

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of primary aldosteronism

Exclusion Criteria

* Allergy to drugs in this study
* Pregnancy
* Severe liver and kidney dysfunction
* Mental illness
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Third Military Medical University

OTHER

Sponsor Role lead

Responsible Party

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Zhiming Zhu

Department of Hypertension and Endocrinology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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No. 10 Changjiang River Branch, Yuzhong District,Chongqing, China

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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sun fang

Role: CONTACT

+862368729587

Facility Contacts

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Jingjing Wang

Role: primary

+86-02368757140

Other Identifiers

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STOP-PA

Identifier Type: -

Identifier Source: org_study_id

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