Using spironolactone as the control, to assess the efficacy and safety of finerenone in patients with primary aldosteronism(PA).
This is a multicenter, randomized study designed to evaluate efficacy and safety of finerenone in patients with PA. PA patients are randomly divided into two groups and treated with finerenone or spironolactone for 12 weeks. Spironolactone will be used as the control, while outcome will be assessed after 12-week treatment. Both drugs will be started at 20mg per day, Dose will be adjusted every four weeks to achieve the targeted blood pressure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
306
Eligible patients will be started finerenone at 20mg per day, Dose will be adjusted every four weeks to achieve the targeted blood pressure (the mean office blood pressure \<140/90 mmHg).
Eligible patients will be started spironolactone at 20mg per day, Dose will be adjusted every four weeks to achieve the targeted blood pressure (the mean office blood pressure \<140/90 mmHg).
the first affiliated hospital of Chongqing medical university
Chongqing, Chongqing Municipality, China
Change from baseline in 24-hour SBP
Change from baseline in 24-hour systolic blood pressure (SBP) assessed by 24-hour ambulatory blood pressure monitoring compared to spironolactone after 12 weeks of finerenone therapy in patients with PA.
Time frame: 12 weeks
Change from baseline in 24-hour DBP
Change from baseline in 24-hour diastolic blood pressure (DBP) assessed by 24-hour ambulatory blood pressure monitoring compared to spironolactone after 12 weeks of finerenone therapy in patients with PA.
Time frame: 12 weeks
Change from baseline in daytime SBP
Change from baseline in daytime systolic blood pressure (SBP) assessed by 24-hour ambulatory blood pressure monitoring compared to spironolactone after 12 weeks of finerenone therapy in patients with PA.
Time frame: 12 weeks
Change from baseline in daytime DBP
Change from baseline in daytime diastolic blood pressure (DBP) assessed by 24-hour ambulatory blood pressure monitoring compared to spironolactone after 12 weeks of finerenone therapy in patients with PA.
Time frame: 12 weeks
Change from baseline in nighttime SBP
Change from baseline in nighttime systolic blood pressure (SBP) assessed by 24-hour ambulatory blood pressure monitoring compared to spironolactone after 12 weeks of finerenone therapy in patients with PA.
Time frame: 12 weeks
Change from baseline in nighttime DBP
Change from baseline in nighttime diastolic blood pressure (DBP) assessed by 24-hour ambulatory blood pressure monitoring compared to spironolactone after 12 weeks of finerenone therapy in patients with PA.
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Time frame: 12 weeks
Blood pressure control rate at the end of the study
Blood pressure control rate was defined as the number of patients with blood pressure controlled (with mean seated office BP\<140/90mmHg at the end of the study)/ total number of patients in each group × 100%.
Time frame: 12 weeks
Serum potassium
Change from baseline in Serum potassium, Blood was drawn to measure potassium.
Time frame: 12 weeks
Hypokalemia control rate at the end of the study
Hypokalemia control rate was defined as the number of hypokalemic patients with serum potassium\>3.5mmol/l at the end of the study/number of hypokalemic patients at baseline× 100%.
Time frame: 12 weeks
Change from baseline in office SBP
Change in office systolic blood pressure from baseline to Week 12, measured in mm Hg.
Time frame: 12 weeks
Change from baseline in office DBP
Change in office diastolic blood pressure from baseline to Week 12, measured in mm Hg.
Time frame: 12 weeks
Plasma renin concentration
Change from baseline in plasma renin concentration,Blood was drawn to measure renin.
Time frame: 12 weeks
Renin normalization rate at the end of the study
The renin normalization rate was defined as the proportion of patients with suppressed renin at baseline who achieved a renin level \>10 μIU/ml at the end of the study.
Time frame: 12 weeks