Primary Aldosteronism
Conditions
Keywords
primary aldosteronism, PCSK9, Statins, Inclisiran
Brief 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.
Interventions
DRUGinclisiran
Subcutaneous inclisiran
DRUGLipophilic statins (such as Simvastatin, Atorvastatin, Fluvastatin, Lovastatin,Pitavastatin)
oral Lipophilic statins (such as Simvastatin, Atorvastatin, Fluvastatin, Lovastatin,Pitavastatin)
oral Spironolactone
oral Amlodipine besylate
Sponsors
Third Military Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in plasma aldosterone level | 24 weeks after randomization |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in systolic and diastolic blood pressure | 24 weeks after randomization |
| Change from baseline in plasma renin concentration | 24 weeks after randomization |
| Change from baseline in 24-hour urinary aldosterone | 24 weeks after randomization |
| Change from baseline in serum potassium level | 24 weeks after randomization |
| Change from baseline in plasma lipid | 24 weeks after randomization |
| Change from baseline in glucose | 24 weeks after randomization |
Countries
China
Contacts
CONTACTLiyuan Yuan
CONTACTZhiming Zhu
Outcome results
None listed