Comparing the Efficacy and Safety of Finerenone and Spironolactone in the Treatment of Primary Aldosteronism

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

96

Participants

Timeline

Start Date

May 31, 2023

Primary Completion Date

March 31, 2025

Study Completion Date

March 31, 2026

Conditions
Primary AldosteronismHypertension
Interventions
DRUG

Finerenone

The participants were randomized in an equal ratio to receive finerenone 10 mg once daily. Patients received the initial dose of study drug for the first 4 weeks of randomized treatment period. Thereafter, the dose of study medication was not changed for patients with adequate BP control. For patients not meeting BP \< 140/90 mmHg at week 4, the dose of study medication was increased to finerenone 20 mg once daily. If BP \> 160/110 mmHg at the time of 8 weeks follow-up, nifedipine 30mg once day was added.

DRUG

Spironolactone

The participants were randomized in an equal ratio to receive spironolactone 20 mg twice daily. Patients received the initial dose of study drug for the first 4 weeks of randomized treatment period. Thereafter, the dose of study medication was not changed for patients with adequate BP control. For patients not meeting BP \< 140/90 mmHg at week 4, the dose of study medication was increased to spironolactone 40 mg twice daily. If BP \> 160/110 mmHg at the time of 8 weeks follow-up, nifedipine 30mg once day was added.

All Listed Sponsors
collaborator

National Key Research and Development Program of China

UNKNOWN

collaborator

National Natural Science Foundation of China

OTHER_GOV

lead

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER