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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hypertension; Primary Aldosteronism; Mineralocorticoid Receptor Antagonist; Statin
• Intervention / Treatment: Drug: Amlodipine besylate combined Spironolactone; Drug: Simvastatin combined with Amlodipine besylate; Drug: Simvastatin combined with Spironolactone and Amlodipine besylate.

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: sun fang; Phone Number: +862368729587; Email: sun_fang2007@163.com

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400042
      • Recruiting
      • No. 10 Changjiang River Branch, Yuzhong District，Chongqing, China
      • Contact: Jingjing Wang; Phone Number: +86-02368757140; Email: wii1017@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Clinical diagnosis of primary aldosteronism

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: Simvastatin combined with Amlodipine besylate; 6-month treatment of Simvastatin combined with Amlodipine besylate
Experimental: 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	Drug: Simvastatin combined with Spironolactone and Amlodipine besylate.; 6-month treatment of Simvastatin combined with Spironolactone and Amlodipine besylate.
Experimental: 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	Drug: Amlodipine besylate combined Spironolactone; 6-month treatment of Amlodipine besylate combined with Spironolactone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes in plasma aldosterone levels	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)	6 month
changes in 24-hour urinary aldosterone levels	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)	6 month

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Third Military Medical University

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2024
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: July 17, 2024
• First Submitted That Met QC Criteria: July 24, 2024
• First Posted (Actual): July 26, 2024

Study Record Updates

• Last Update Posted (Estimated): November 22, 2024
• Last Update Submitted That Met QC Criteria: November 19, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: hypertension; Statin; primary aldosteronism
• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Adrenal Gland Diseases; Adrenocortical Hyperfunction; Hypertension; Hyperaldosteronism; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hormones, Hormone Substitutes, and Hormone Antagonists; Enzyme Inhibitors; Antimetabolites; Membrane Transport Modulators; Hormone Antagonists; Diuretics; Natriuretic Agents; Calcium Channel Blockers; Vasodilator Agents; Antihypertensive Agents; Mineralocorticoid Receptor Antagonists; Diuretics, Potassium Sparing; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Spironolactone; Amlodipine; Simvastatin
• Other Study ID Numbers: STOP-PA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No