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

NCT05814770 | Not Yet Recruiting Phase 4

• 1 other identifier: PA2023
• Study Type: interventional
• Target: 96
• Locations: 0 countries
• Sites: N/A

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

Keywords

primary aldosteronism; hypertension; finerenone; spironolactone; treatment

Outcome Measures

Primary Outcomes (1)

• Hypertension remission rate.

  The proportion of patients with blood pressure\<140/90 mmHg at 12 weeks.

  12 weeks.

Secondary Outcomes (5)

• The change of systolic and diastolic BP from the baseline level.

  Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks.

• Change of serum potassium level

  Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks.

• 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.

• Proportion of patients with normal serum.

  Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks.

Study Arms (2)

Finerenone

EXPERIMENTAL

Drug: Finerenone

Spironolactone

ACTIVE COMPARATOR

Drug: Spironolactone

Interventions

Finerenone 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.

Also known as: Kerendia

Finerenone

Spironolactone 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.

Spironolactone

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18-75 years old.
• History of hypertension, DBP \<120 mmHg, SBP \<180 mmHg.
• Serum potassium level ≥ 2.5 mmol/L.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead
• National Key Research and Development Program of China: collaborator
• National Natural Science Foundation of China: collaborator

MeSH Terms

Conditions

Hyperaldosteronism; Hypertension

Interventions

finerenone; Spironolactone

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Ping Li

  The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  STUDY DIRECTOR

Central Study Contacts

Ping Li, Ph.D

CONTACT

86-025-83106666; li78321@yeah.net

Fan Yang, Ph.D

CONTACT

86-025-83106666; yangfan_0210@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2023
• First Posted: April 18, 2023
• Study Start: May 1, 2023
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2026
• Last Updated: April 18, 2023

Record last verified: 2023-03