Actively Recruiting

Phase 4
Age: 18Years - 70Years
All Genders
ID06523465

A Prospective, Multi-center, Randomized Trial Comparing Statin with Calcium Channel Blocker to Mineralocorticoid Receptor Antagonist with Calcium Channel Blocker in Primary Aldosteronism Treatment

Led by Third Military Medical University · Updated on 2024-11-22

180

Participants Needed

1

Research Sites

39 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating treatments for primary aldosteronism (PA), a condition with limited drug options that affect long-term heart health. This phase 4, randomized trial plans to study three different drug combinations to observe their effects on blood hormone levels, blood pressure, and cardiovascular risks over time. Participants will be randomly assigned to one of three groups: one receiving Simvastatin combined with Amlodipine besylate, another receiving Simvastatin combined with Spironolactone and Amlodipine besylate, and the last receiving Amlodipine besylate combined with Spironolactone. Each treatment will last for six months, allowing comparison of how these combinations influence plasma aldosterone, urinary aldosterone, and other health measures. During the study, participants will have their blood hormone levels, blood pressure, potassium, renin, cholesterol, and glucose monitored at six months. These assessments help determine changes related to the treatments and the ongoing cardiovascular risk. The study will run until September 2026, with careful monitoring to track patient health and treatment response throughout the six-month treatment period.

CONDITIONS

Brief Title

Statin Combined with Amlodipine Treats Primary Aldosteronism

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Clinical diagnosis of primary aldosteronism
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - 6 months

Participants receive one of the study drug combinations for primary aldosteronism treatment.

Visits as per treatment schedule for medication administration and monitoring

Trial Site Locations

Total: 1 location

1

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

Chongqing, Chongqing Municipality, China, 400042

Actively Recruiting

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Research Team

S

sun fang

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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