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Comparing Inclisiran Versus Statin for Primary Aldosteronism

RecruitingNAAges 18 Years - 70 YearsAllThird Military Medical University
NCT07884955 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Primary aldosteronism represents one of the leading causes of resistant hypertension. Circulating cholesterol is established as the exclusive substrate for adrenal aldosterone synthesis, and statins, which suppress cholesterol production, are currently widely applied in clinical settings. Emerging clinical evidence has demonstrated that in patients with essential hypertension, the plasma aldosterone level decreased by 43% (from 13.9 ng/dL to 7.9 ng/dL) after treatment with PCSK9 inhibitors. However, the effect of PCSK9 inhibitors with superior lipid-lowering efficacy combined with amlodipine besylate on aldosterone levels remains elusive. The present clinical trial adopted inclisiran, a PCSK9 inhibitor with well-documented clinical safety and robust lipid-lowering effects, in combination with amlodipine besylate. Through randomized grouping intervention and follow-up, this study aimed to

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Patients with hypertension aged18-70years. 2. Meeting the diagnostic criteria for primary aldosteronism (PA) according to the \*Expert Consensus on the Diagnosis and Treatment of Primary Aldosteronism (2025 Edition) 3. Patients either untreated or on antihypertensive therapy; after a 1-2week washout period, blood pressure is \<160/100mmHg. 4. Serum potassium at the end of the run-in period: 3mmol/L ≤ serum potassium \<5mmol/L. 5. Voluntary participation in the trial and provision of written informed consent. Exclusion Criteria: 1. Office blood pressure \>180/110mmHg. 2. Severe hepatic insufficiency or severe renal insufficiency. 3. Acute coronary syndrome, myocardial infarction, percutaneous coronary intervention, or cerebrovascular accident within the previous 6 months; heart failure of NYHA class II-IV. 4. Serum potassium \<2.5mmol/L or \>5.5mmol/L. 5. Pregnancy or planned pregnancy within 1year. 6. Neurological or psychiatric disorders. 7. Concurrent malignant neoplasm. 8. Low-density-lipoprotein-cholesterol(LDL-C) \<2.6mmol/L. 9. Any other conditions that, in the investigator's opinion, may interfere with efficacy and/or safety assessment of the study (including but not limited to poor subject compliance or inability to attend scheduled follow-up due to long-distance residence).
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What it tests

  • inclisiran
  • Lipophilic statins (such as Simvastatin, Atorvastatin, Fluvastatin, Lovastatin,Pitavastatin)
  • Spironolactone (drug)
  • Amlodipine besylate
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Where

1 site
Daping Hospital,Third Military Medical University
Chongqing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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