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

NCT ID: NCT05814770

Last Updated: 2023-04-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-31
• Study Completion Date: 2026-03-31

Brief Summary

Primary aldosteronism (PA) is thought to be the most common secondary endocrine form of hypertension. Compared with patients with essential hypertension with similar blood pressure, patients with PA have significantly higher atrial fibrillation, myocardial infarction, heart failure, stroke, deterioration of renal function and all-cause mortality. Therefore, early and systematic implementation of effective surgical or medical treatment is essential to prevent or reverse the excess vascular events and mortality of these patients. The patients with bilateral PA were mainly treated with mineralocorticoid receptor antagonists (MRAs). The MRA spironolactone is effective at lowering BP and reversing the harmful metabolic consequences, but its use is limited by adverse effects such as gynaecomastia, mastodynia, menstrual abnormalities and impotence due to its agonist activity at the progesterone receptor and antagonist activity at the androgen receptor. Finerenone is claimed to be a more selective blocker of the mineralocorticoid receptor than spironolactone being associated with fewer antiandrogenic side-effects. In this study, we will compare the efficacy, safety and tolerability of finerenone versus spironolactone in patients with hypertension associated with primary aldosteronism.

Conditions

Primary Aldosteronism; Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Finerenone

Group Type: EXPERIMENTAL

Finerenone

Intervention Type: DRUG

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.

Spironolactone

Group Type: ACTIVE_COMPARATOR

Spironolactone

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Kerendia

Eligibility Criteria

Inclusion Criteria

• 1.Age: 18-75 years old.
• 2.History of hypertension, DBP <120 mmHg, SBP <180 mmHg.
• 3.Serum potassium level ≥ 2.5 mmol/L.
• 4.Primary Aldosteronis diagnosed by increased aldosterone renin ratio (ARR) > 30 ng/dl: ng/ml/h, and serum aldosterone levels ≥15 ng / dl, and confirmed by captopril inhibition test.

Exclusion Criteria

• 1. Abnormal renal function: serum creatinine ≥ 2 × ULN or eGFR ≤ 60 ml/(min * 1.73m2);
• 2. Abnormal liver function: ALT and AST ≤ 2.5 × ULN, TBIL ≤ 1.5 × ULN；
• 3. Cardiac insufficiency, acute myocardial infarction, stroke or other acute cardiovascular events within 6 months;
• 4. Take spironolactone, guanethidine or reserpine 30 days before enrollment;
• 5. Known or suspected tumor; Other autoimmune diseases, uncontrolled infectious diseases, serious respiratory, blood and nervous system diseases;
• 6. There is a pregnancy plan in pregnancy or 3 months before and after treatment. Breast-feeding women;
• 7. Those who have mental illness, alcohol or drug abuse and cannot cooperate with treatment.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Key Research and Development Program of China

UNKNOWN

Sponsor Role: collaborator

National Natural Science Foundation of China

OTHER_GOV

Sponsor Role: collaborator

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ping Li

Role: STUDY_DIRECTOR

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Central Contacts

Ping Li, Ph.D

Role: CONTACT

li78321@yeah.net

86-025-83106666

Fan Yang, Ph.D

Role: CONTACT

yangfan_0210@126.com

86-025-83106666

Other Identifiers

PA2023

Identifier Type: -

Identifier Source: org_study_id