No phaseRecruiting
Comparing Inclisiran Versus Statin for Primary Aldosteronism
A Randomized Controlled Study Comparing Inclisiran Plus Spironolactone Versus Statin Plus Spironolactone for Primary Aldosteronism
- Sponsor
- Third Military Medical University (Academic or other)
- Enrollment
- 50 planned
- Conditions
- Primary Aldosteronism
- Interventions
- inclisiran; Lipophilic statins (such as Simvastatin, Atorvastatin, Fluvastatin, Lovastatin,Pitavastatin); Spironolactone (drug); Amlodipine besylate
- Ages
- adults, older adults
- Registry
- NCT07884955
Full record on ClinicalTrials.gov
From the registry
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…
Primary outcomes
- Change from baseline in plasma aldosterone level
History
Primary completion expected
Registered
Started