Health TrialsbyHealthPanel

Statin Combined with Amlodipine Treats Primary Aldosteronism

ConditionsPrimary AldosteronismStatinMineralocorticoid Receptor AntagonistHypertension
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-70
SponsorThird Military Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Clinical diagnosis of primary aldosteronism

Disqualifiers

Allergy to drugs in this study

Pregnancy

Severe liver and kidney dysfunction

Mental illness

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

180 Participants
are divided into 3 treatment groups
Group A: Simvastatin combined with Amlodipine besylateExperimental treatment 1 intervention
Group B: Simvastatin combined with Spironolactone and Amlodipine besylate.Experimental treatment 1 intervention
Group C: Amlodipine besylate combined with SpironolactoneExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
6 month
2

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)

Time frame
6 month

Secondary outcomes

1

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

Time frame
6 month
2

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)

Time frame
6 month
3

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)

Time frame
6 month
4

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)

Time frame
6 month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Third Military Medical University

Lead sponsor

Source ClinicalTrials.gov
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