search
Back to results

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

Primary Purpose

Primary Aldosteronism, Hypertension

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Finerenone
Spironolactone
Sponsored by
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Aldosteronism focused on measuring primary aldosteronism, hypertension, finerenone, spironolactone, treatment

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Finerenone

    Spironolactone

    Arm Description

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    The change of systolic and diastolic BP from the baseline level.
    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
    Change of serum potassium level (mmol/L)
    Changes of plasma renin activity and ARR.
    Incidence of Treatment-Adverse Events as assessed by gynaecomastia, mastodynia, menstrual abnormalities, impotence, hyperkalemia and other adverse events.
    Adverse effects such as gynaecomastia, mastodynia, menstrual abnormalities and impotence due to its agonist activity. Hyperkalemia. Other adverse events.
    Proportion of patients with normal serum.

    Full Information

    First Posted
    March 13, 2023
    Last Updated
    April 3, 2023
    Sponsor
    The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
    Collaborators
    National Key Research and Development Program of China, National Natural Science Foundation of China
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05814770
    Brief Title
    Comparing the Efficacy and Safety of Finerenone and Spironolactone in the Treatment of Primary Aldosteronism
    Official Title
    Compare the Efficacy and Safety of Finerenone, a New Type of Mineralocorticoid Receptor Antagonist, and Spironolactone in the Treatment of Primary Aldosteronism: a Single-Center, Prospective, Randomized Controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 2023 (Anticipated)
    Primary Completion Date
    March 2025 (Anticipated)
    Study Completion Date
    March 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
    Collaborators
    National Key Research and Development Program of China, National Natural Science Foundation of China

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Primary Aldosteronism, Hypertension
    Keywords
    primary aldosteronism, hypertension, finerenone, spironolactone, treatment

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    96 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Finerenone
    Arm Type
    Experimental
    Arm Title
    Spironolactone
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Finerenone
    Other Intervention Name(s)
    Kerendia
    Intervention Description
    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
    Intervention Name(s)
    Spironolactone
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Hypertension remission rate.
    Description
    The proportion of patients with blood pressure<140/90 mmHg at 12 weeks.
    Time Frame
    12 weeks.
    Secondary Outcome Measure Information:
    Title
    The change of systolic and diastolic BP from the baseline level.
    Description
    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.
    Time Frame
    Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks.
    Title
    Change of serum potassium level
    Description
    Change of serum potassium level (mmol/L)
    Time Frame
    Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks.
    Title
    Changes of plasma renin activity and ARR.
    Time Frame
    Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks.
    Title
    Incidence of Treatment-Adverse Events as assessed by gynaecomastia, mastodynia, menstrual abnormalities, impotence, hyperkalemia and other adverse events.
    Description
    Adverse effects such as gynaecomastia, mastodynia, menstrual abnormalities and impotence due to its agonist activity. Hyperkalemia. Other adverse events.
    Time Frame
    Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks.
    Title
    Proportion of patients with normal serum.
    Time Frame
    Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ping Li, Ph.D
    Phone
    86-025-83106666
    Email
    li78321@yeah.net
    First Name & Middle Initial & Last Name or Official Title & Degree
    Fan Yang, Ph.D
    Phone
    86-025-83106666
    Email
    yangfan_0210@126.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ping Li
    Organizational Affiliation
    The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs