Status:
UNKNOWN
Efficacy and Safety of Finerenone vs. Spironolactone in Patients With Primary Aldosteronism
Lead Sponsor:
Shanghai Jiao Tong University School of Medicine
Conditions:
Primary Aldosteronism
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
To study the efficacy and safety of finerenone vs. spironolactone in patients with primary aldosteronism
Detailed Description
1. Study design: This is a multi-center, double-blind, randomized, non-inferiority trial of finerenone vs. spironolactone in hypertensive patients with primary aldosteronism (PA). All patients will be...
Eligibility Criteria
Inclusion
- Age: 18-75 years old.
- History of hypertension, Clinic DBP \<110 mmHg, SBP \<180 mmHg without any antihypertensive drugs for 2 weeks.
- Primary Aldosteronism diagnosed and confirmed by captopril inhibition test or Saline infusion test.
- At the end of induction, Serum potassium level ≥ 3 mmol/L but less than 5 mmol/L.
- Signed the informed consent
Exclusion
- Other kinds of secondary hypertension
- Obesity with BMI\>30kg/m²（BMI= kg/㎡）
- Serum potassium \> 5.5 mmol/L
- Serious hypertension（msSBP≥180mmHg, and/or msDBP≥110mmHg）
- Abnormal renal function: serum creatinine ≥ 2 × ULN or eGFR \< 25 ml/(min \* 1.73㎡);
- Abnormal liver function: ALT and AST ≥ 2 × ULN；
- Cardiac insufficiency, acute myocardial infarction, stroke or other acute cardiovascular events within 6 months;
- Take spironolactone, guanethidine or reserpine 30 days before enrollment;
- Known or suspected tumor; Other autoimmune diseases, uncontrolled infectious diseases, serious respiratory, blood and nervous system diseases;
- There is a pregnancy plan in pregnancy or 3 months before and after treatment. Breast-feeding women;
- Those who have mental illness, alcohol or drug abuse and cannot cooperate with treatment.
- Be allergic to the study drugs
- Without Signed the informed consent
- Anticipating another clinical trial
Key Trial Info
Start Date :
December 16 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 16 2024
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06164379
Start Date
December 16 2023
End Date
December 16 2024
Last Update
December 11 2023
Active Locations (1)
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1
Shanghai Institite of Hypertension, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025