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NCT Number: NCT06523465

Statin Combined with Amlodipine Treats Primary Aldosteronism

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.

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Key information

Conditions

Primary Aldosteronism Adrenal Gland Diseases Adrenocortical Hyperfunction Cardiovascular Diseases Endocrine System Diseases Hyperaldosteronism Hypertension Mineralocorticoid Receptor Antagonist Statin Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Chongqing, Chongqing Municipality, 400042, China

Location status: Recruiting

Location contact

Jingjing Wang

CONTACT

[email protected]

+86-02368757140

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of primary aldosteronism

Exclusion criteria

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

Treatment and study plan

Simvastatin combined with Amlodipine besylate

Drug

6-month treatment of Simvastatin combined with Amlodipine besylate

Simvastatin combined with Spironolactone and Amlodipine besylate.

Drug

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

Amlodipine besylate combined Spironolactone

Drug

6-month treatment of Amlodipine besylate combined with Spironolactone

Primary outcomes

  1. changes in plasma aldosterone levels

    Time frame: 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)

  2. changes in 24-hour urinary aldosterone levels

    Time frame: 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)

Secondary outcomes

  1. changes in office blood pressure and home blood pressure

    Time frame: 6 month

    Record office blood pressure at baseline and at follow-up after medical treatment (mmHg), and compare between groups and within groups

  2. changes in serum potassium levels

    Time frame: 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)

  3. changes in serum renin level

    Time frame: 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)

  4. changes in plasma cholesterol levels

    Time frame: 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)

  5. changes in blood glucose

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

sun fang

CONTACT

[email protected]

+862368729587

Sponsors and collaborators

Lead sponsor

Third Military Medical University

Other

Registry information

Official study title

A Prospective, Multi-center, Randomized Trial to Compare Statin Combined with CCB to MRA Combined with CCB in Primary Aldosteronism Treatment

Acronym: STOP-PA

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jul 26, 2024
Registry last updated
Nov 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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