Inclisiran vs. Statin for Primary Aldosteronism

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study compares two lipid-lowering strategies in adults with primary aldosteronism and hypertension. Participants are randomized to receive inclisiran-based therapy or a statin-based regimen, alongside standard antihypertensive care. The study aims to see how these treatments influence aldosterone levels and blood pressure, while monitoring safety and lipid outcomes. Eligible participants are adults 18-70 with PA, controlled blood pressure after washout, and stable potassium within a defined range. The trial is conducted at Daping Hospital, with Third Military Medical University as the lead sponsor.

Why it matters

Who can join: the full rules

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).

Where it's running

• Daping Hospital,Third Military Medical University
  Chongqing, Chongqing Municipality, China Recruiting

Study contacts

• Study coordinator: Liyuan Yuan
• Email: 706539967@qq.com
• Phone: +8617374960635

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Kidney stiffness measured by ultrasound in hypertension and healthy volunteers

  This study tests whether kidney stiffness measured by a non-invasive ultrasound method differs between people with high blood pressure and healthy individuals.

  Recruiting Azienda Ospedaliera di Padova · Padova, PD · NCT07914075

• Left-atrial Fibrosis in Persistent Atrial Fibrillation and Its Comorbidities

  This study tests how comorbid conditions like sleep apnea and primary aldosteronism relate to left-atrial fibrosis and AF recurrence in patients undergoing ablation.

  Recruiting University Hospital Augsburg · Augsburg, Bavaria · NCT07857044

• Metomidate PET-CT vs Usual Care for Primary Aldosteronism

  This study tests whether [11C] metomidate PET-CT can help orient treatment for people with primary aldosteronism compared with the usual adrenal venous sampling approach.

  Recruiting Chinese University of Hong Kong · Shatin · NCT07814105

• Captopril Test with LC-MS/MS for Aldosterone and Renin in Primary Aldosteronism

  This study tests whether measuring aldosterone with LC-MS/MS during a captopril test can better diagnose primary aldosteronism.

  Recruiting Peking Union Medical College Hospital · Beijing, Beijing Municipality · NCT07691801

• Finerenone vs. Spironolactone for Primary Aldosteronism

  This trial tests whether finerenone works as well as spironolactone to lower blood pressure and improve related health measures in adults with primary aldosteronism.

  Recruiting Bangladesh Medical University · Dhaka · NCT07688928

• Intensive vs. Standard Blood Pressure Control in Primary Aldosteronism

  In people with primary aldosteronism, this study tests whether aiming for a systolic BP under 120 mmHg is better than under 140 mmHg for lowering cardiovascular risk.

  Recruiting Chongqing Medical University · Chongqing · NCT07673445

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.