- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07884955
Comparing Inclisiran Versus Statin for Primary Aldosteronism
A Randomized Controlled Study Comparing Inclisiran Plus Spironolactone Versus Statin Plus Spironolactone for Primary Aldosteronism
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.
Studieoversikt
Status
Forhold
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Liyuan Yuan
- Telefonnummer: +8617374960635
- E-post: 706539967@qq.com
Studer Kontakt Backup
- Navn: Zhiming Zhu
Studiesteder
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Chongqing Municipality
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Chongqing, Chongqing Municipality, Kina, 400042
- Rekruttering
- Daping Hospital,Third Military Medical University
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Ta kontakt med:
- Zhiming Zhu
- Telefonnummer: +8613608313322
- E-post: hbpcms@sina.com
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Patients with hypertension aged18-70years.
- Meeting the diagnostic criteria for primary aldosteronism (PA) according to the *Expert Consensus on the Diagnosis and Treatment of Primary Aldosteronism (2025 Edition)
- Patients either untreated or on antihypertensive therapy; after a 1-2week washout period, blood pressure is <160/100mmHg.
- Serum potassium at the end of the run-in period: 3mmol/L ≤ serum potassium <5mmol/L.
- Voluntary participation in the trial and provision of written informed consent.
Exclusion Criteria:
- Office blood pressure >180/110mmHg.
- Severe hepatic insufficiency or severe renal insufficiency.
- Acute coronary syndrome, myocardial infarction, percutaneous coronary intervention, or cerebrovascular accident within the previous 6 months; heart failure of NYHA class II-IV.
- Serum potassium <2.5mmol/L or >5.5mmol/L.
- Pregnancy or planned pregnancy within 1year.
- Neurological or psychiatric disorders.
- Concurrent malignant neoplasm.
- Low-density-lipoprotein-cholesterol(LDL-C) <2.6mmol/L.
- 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).
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Subcutaneous inclisiran plus oral amlodipine besylate and spironolactone
Participants receive inclisiran 284 mg subcutaneously (initial dose, repeat at 3 months) plus oral amlodipine besylate 5 mg once daily and oral spironolactone 20 mg once daily. |
Subcutaneous inclisiran oral Spironolactone oral Amlodipine besylate |
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Placebo komparator: Statin plus amlodipine besylate and spironolactone
Participants receive oral simvastatin 40 mg, oral amlodipine besylate 5 mg once daily, and oral spironolactone 20 mg once daily. |
oral Spironolactone oral Amlodipine besylate oral Lipophilic statins (such as Simvastatin, Atorvastatin, Fluvastatin, Lovastatin,Pitavastatin) |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Change from baseline in plasma aldosterone level
Tidsramme: 24 weeks after randomization
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24 weeks after randomization
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Change from baseline in systolic and diastolic blood pressure
Tidsramme: 24 weeks after randomization
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24 weeks after randomization
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Change from baseline in plasma renin concentration
Tidsramme: 24 weeks after randomization
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24 weeks after randomization
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Change from baseline in 24-hour urinary aldosterone
Tidsramme: 24 weeks after randomization
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24 weeks after randomization
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Change from baseline in serum potassium level
Tidsramme: 24 weeks after randomization
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24 weeks after randomization
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Change from baseline in plasma lipid
Tidsramme: 24 weeks after randomization
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24 weeks after randomization
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Change from baseline in glucose
Tidsramme: 24 weeks after randomization
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24 weeks after randomization
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Samarbeidspartnere og etterforskere
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Baudrand R, Pojoga LH, Vaidya A, Garza AE, Vohringer PA, Jeunemaitre X, Hopkins PN, Yao TM, Williams J, Adler GK, Williams GH. Statin Use and Adrenal Aldosterone Production in Hypertensive and Diabetic Subjects. Circulation. 2015 Nov 10;132(19):1825-33. doi: 10.1161/CIRCULATIONAHA.115.016759. Epub 2015 Oct 2.
- Wu H, He H, Han T, Tian X, Zhu Z. Targeting cholesterol-dependent adrenal steroidogenesis for management of primary aldosteronism. Trends Endocrinol Metab. 2025 Sep;36(9):789-801. doi: 10.1016/j.tem.2024.12.001. Epub 2025 Jan 6.
- Izkhakov E, Shacham Y, Serebro M, Yaish I, Marcus Y, Shefer G, Tordjman K, Greenman Y, Stern N, Ziv-Baran T. The Effect of the PCSK9 Inhibitor Evolocumab on Aldosterone Secretion among High Cardiovascular Risk Patients: A Pilot Study. J Clin Med. 2021 Jun 5;10(11):2504. doi: 10.3390/jcm10112504.
- Navarese EP, Kolodziejczak M, Schulze V, Gurbel PA, Tantry U, Lin Y, Brockmeyer M, Kandzari DE, Kubica JM, D'Agostino RB Sr, Kubica J, Volpe M, Agewall S, Kereiakes DJ, Kelm M. Effects of Proprotein Convertase Subtilisin/Kexin Type 9 Antibodies in Adults With Hypercholesterolemia: A Systematic Review and Meta-analysis. Ann Intern Med. 2015 Jul 7;163(1):40-51. doi: 10.7326/M14-2957.
- Capponi AM. Regulation of cholesterol supply for mineralocorticoid biosynthesis. Trends Endocrinol Metab. 2002 Apr;13(3):118-21. doi: 10.1016/s1043-2760(01)00538-0.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Sykdommer i det endokrine systemet
- Binyresykdommer
- Binyrebark hyperfunksjon
- Hyperaldosteronisme
- Organiske kjemikalier
- Pyridiner
- Heterocykliske forbindelser, 1-ring
- Heterocykliske forbindelser
- Heterocykliske forbindelser, 2-ring
- Heterocykliske forbindelser, smeltet ringen
- Fettsyrer
- Lipider
- Azoler
- Hydrokarboner
- Hydrokarboner, syklisk
- Naftalener
- Polysykliske aromatiske hydrokarboner
- Hydrokarboner, aromatisk
- Polysykliske forbindelser
- Indoler
- Gravaner
- Steroider
- Smeltede ringforbindelser
- Laktoner
- Pyrroles
- Heptansyrer
- Gravide
- Dihydropyridiner
- Atorvastatin
- Spironolakton
- Amlodipin
- Simvastatin
- Lovastatin
- Farmasøytiske preparater
- Pitavastatin
- Aln-PCS
- Fluvastatin
Andre studie-ID-numre
- ISPA
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