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

Phase 4

Not yet recruiting

• Conditions: Primary Aldosteronism; Hypertension
• Interventions: Drug: Finerenone; Drug: Spironolactone

• Registration Number: NCT05814770
• Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-03
• Study First Submitted: 2023-03-13
• Study First Submitted QC: 2023-04-03
• Last Update Submitted: 2023-04-03
• Study First Posted: 2023-04-18
• Last Update Posted: 2023-04-18
• Study Start: 2023-05
• Primary Completion: 2025-03
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 96

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Finerenone	Finerenone	-
Spironolactone	Spironolactone	-

Primary Outcome Measures

Name	Time	Method
Hypertension remission rate.	12 weeks.	The proportion of patients with blood pressure\<140/90 mmHg at 12 weeks.

Secondary Outcome Measures

Name	Time	Method
The change of systolic and diastolic BP from the baseline level.	Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks.	To compare the antihypertensive effect of finerenone versus spironolactone and to establish the noninferiority of finerenone by measuring the mean change from baseline to the week 16 endpoint in end- of-dose (trough) seated DBP.
Change of serum potassium level	Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks.	Change of serum potassium level (mmol/L)
Changes of plasma renin activity and ARR.	Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks.
Incidence of Treatment-Adverse Events as assessed by gynaecomastia, mastodynia, menstrual abnormalities, impotence, hyperkalemia and other adverse events.	Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks.	1. Adverse effects such as gynaecomastia, mastodynia, menstrual abnormalities and impotence due to its agonist activity.; 2. Hyperkalemia.; 3. Other adverse events.
Proportion of patients with normal serum.	Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks.