Finerenone for Patients With Primary Aldosteronism (FAIRY)
NCT Number: NCT06457074
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Primary Aldosteronism
Interventions: DRUG: Finerenone Oral Tablet|DRUG: Spironolactone Oral Tablet
Sponsor: Qifu Li
Collaborators: The Affiliated Hospital Of Southwest Medical University|The First Affiliated Hospital of Zhengzhou University|Second Affiliated Hospital, School of Medicine, Zhejiang University|Changzhi Medical College
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 306
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-04
Completion Date: 2026-06-01
Locations: the first affiliated hospital of Chongqing medical university, Chongqing, Chongqing, 400016, China

Summary:
Using spironolactone as the control, to assess the efficacy and safety of finerenone in patients with primary aldosteronism(PA).

Primary Outcome Measures: 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., 12 weeks
Secondary Outcome Measures: 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., 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., 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., 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., 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., 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%., 12 weeks|Serum potassium, Change from baseline in Serum potassium, Blood was drawn to measure potassium., 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%., 12 weeks|Plasma renin concentration, Change from baseline in plasma renin concentration,Blood was drawn to measure renin., 12 weeks
Other Outcome Measures: Proportion of subjects with AEs, Adverse events(AEs) defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment., 12 weeks|Proportion of subjects with SAEs and AEs leading to discontinuation of treatment with study drug, Serious adverse events(SAEs) results in any of the following outcomes:Death;A life-threatening AE;Requires hospitalization or prolongation of existing hospitalizations;A persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions., 12 weeks|Change in eGFR from baseline., Blood was drawn to measure eGFR（mL/min/1.73m2）, 12 weeks|Change from baseline in urinary albumin-to-creatinine ratio(UACR), Urine will be collected to measure UACR, 12 weeks|Change from baseline in urinary Change in the UACR from baseline>30(mg/g Cr)., Urine will be collected to measure UACR, 12 weeks