NCT06523465

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for phase_4

Timeline
5mo left

Started Sep 2024

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress81%
Sep 2024Sep 2026

First Submitted

Initial submission to the registry

July 17, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 26, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

September 10, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Expected
Last Updated

November 22, 2024

Status Verified

November 1, 2024

Enrollment Period

1.3 years

First QC Date

July 17, 2024

Last Update Submit

November 19, 2024

Conditions

Primary AldosteronismStatinMineralocorticoid Receptor AntagonistHypertension

Keywords

primary aldosteronismhypertensionStatin

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (5)

  • changes in office blood pressure and home blood pressure

    6 month

  • changes in serum potassium levels

    6 month

  • changes in serum renin level

    6 month

  • changes in plasma cholesterol levels

    6 month

  • changes in blood glucose

    6 month

Study Arms (3)

Simvastatin combined with Amlodipine besylate

EXPERIMENTAL

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

Simvastatin combined with Spironolactone and Amlodipine besylate.

EXPERIMENTAL

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.

Amlodipine besylate combined with Spironolactone

EXPERIMENTAL

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

Interventions

Simvastatin combined with Amlodipine besylateDRUG

6-month treatment of Simvastatin combined with Amlodipine besylate

Simvastatin combined with Amlodipine besylate
Simvastatin combined with Spironolactone and Amlodipine besylate.DRUG

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

Simvastatin combined with Spironolactone and Amlodipine besylate.
Amlodipine besylate combined SpironolactoneDRUG

6-month treatment of Amlodipine besylate combined with Spironolactone

Amlodipine besylate combined with Spironolactone

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of primary aldosteronism

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Chongqing, Chongqing Municipality, 400042, China

RECRUITING

MeSH Terms

Conditions

HyperaldosteronismHypertension

Interventions

AmlodipineSpironolactone

Condition Hierarchy (Ancestors)

Adrenocortical HyperfunctionAdrenal Gland DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsLactonesOrganic ChemicalsPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Central Study Contacts

sun fang

CONTACT

+862368729587sun_fang2007@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Hypertension and Endocrinology

Study Record Dates

First Submitted

July 17, 2024

First Posted

July 26, 2024

Study Start

September 10, 2024

Primary Completion

December 30, 2025

Study Completion (Estimated)

September 30, 2026

Last Updated

November 22, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)