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Clinical Trials in China / NCT07884955
Recruiting Not applicable

Comparing Inclisiran Versus Statin for Primary Aldosteronism

NCT07884955 · tracked via the Priya Life Science China tracker
Sponsor
Third Military Medical University
Phase
Not applicable
Started
2026-10-01
Last updated
2026-10-21

Condition(s) studied

Primary Aldosteronism

Investigational drug(s) / intervention(s)

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

inclisiran: Subcutaneous inclisiran

Lipophilic statins (such as Simvastatin, Atorvastatin, Fluvastatin, Lovastatin,Pitavastatin): oral Lipophilic statins (such as Simvastatin, Atorvastatin, Fluvastatin, Lovastatin,Pitavastatin)

Spironolactone (drug): oral Spironolactone

Amlodipine besylate: oral Amlodipine besylate

Study summary

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 compare the differential effects of two therapeutic regimens-inclisiran-based therapy and statin-based therapy-on plasma aldosterone levels, as well as improvements in a spectrum of clinical parameters including blood pressure , serum potassium and so on in patients with primary aldosteronism. The outcomes of this trial are expected to provide novel and more effective pharmacological strategies for the management of primary aldosteronism.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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).

Primary outcome measure(s)

  • Change from baseline in plasma aldosterone level — 24 weeks after randomization

Trial sites (1)

FacilityCityRegionStatus
Daping Hospital,Third Military Medical University Chongqing Chongqing Municipality Recruiting

On this site

📄 Leqvio (inclisiran) drug profile →

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Other trials for the same condition

A Phase II Clinical Study on the Efficacy and Safety of HRS-1780 in Participants With Primary Aldosteronism Active, not recruiting
Primary Aldosteronism: Superselective Embolization vs. Laparoscopic Endocrine Curative Therapy Recruiting
Comparative Study of Perioperative Cardiac Injury in Patients With Functional Adrenal Tumors Enrolling by invitation
68Ga-Pentixafor PET/CT Versus Adrenal Vein Sampling in Diagnosing Unilateral Subtype of Primary Aldosteronism Concurrent With Autonomous Cortisol Secretion (PREDICT) Recruiting
Endoscopic Ultrasound-Guided Ethanol Ablation for Aldosterone-Producing Adenoma Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07884955 on ClinicalTrials.gov ↗ ← All trials in China