Efficacy and Safety of Finerenone vs. Spironolactone in Patients With Primary Aldosteronism

• Status: Not yet recruiting
• Trial end date: 2024-12-16
• Target enrollment: 0
• Participant gender: All

Summary

To study the efficacy and safety of finerenone vs. spironolactone in patients with primary aldosteronism

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Jiao Tong University School of Medicine
• Treatments: Spironolactone

Criteria

Inclusion Criteria:

1. Age: 18-75 years old.

2. History of hypertension, Clinic DBP <110 mmHg, SBP <180 mmHg without any antihypertensive drugs for 2 weeks.

3. Primary Aldosteronism diagnosed and confirmed by captopril inhibition test or Saline infusion test.

4. At the end of induction, Serum potassium level ≥ 3 mmol/L but less than 5 mmol/L.

5. Signed the informed consent

Exclusion Criteria:

1. Other kinds of secondary hypertension

2. Obesity with BMI>30kg/m²（BMI= kg/㎡）

3. Serum potassium > 5.5 mmol/L

4. Serious hypertension（msSBP≥180mmHg, and/or msDBP≥110mmHg）

5. Abnormal renal function: serum creatinine ≥ 2 × ULN or eGFR < 25 ml/(min * 1.73㎡);

6. Abnormal liver function: ALT and AST ≥ 2 × ULN；

7. Cardiac insufficiency, acute myocardial infarction, stroke or other acute cardiovascular events within 6 months;

8. Take spironolactone, guanethidine or reserpine 30 days before enrollment;

9. Known or suspected tumor; Other autoimmune diseases, uncontrolled infectious diseases, serious respiratory, blood and nervous system diseases;

10. There is a pregnancy plan in pregnancy or 3 months before and after treatment. Breast-feeding women;

11. Those who have mental illness, alcohol or drug abuse and cannot cooperate with treatment.

12. Be allergic to the study drugs

13. Without Signed the informed consent

14. Anticipating another clinical trial