Primary AldosteronismPhase 4NCT05814770
Comparing the Efficacy and Safety of Finerenone and Spironolactone in the Treatment of Primary Aldosteronism
A Phase 4 study testing Finerenone and Spironolactone in people with Primary Aldosteronism and Hypertension, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Aldosteronism, Hypertension
- What is being tested?
- Finerenone and Spironolactone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- May 2023to Mar 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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
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
- Being tested
- Finerenone, Spironolactone
- Keywords
- primary aldosteronism, hypertension, finerenone, spironolactone, treatment
- Medical subject headings
- Hyperaldosteronism, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FinerenoneDrug
Also called Kerendia
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.
SpironolactoneDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Finerenone | Experimental | Not described Receives: Drug: Finerenone |
| Spironolactone | Active comparator | Not described Receives: Drug: Spironolactone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypertension remission rate.
The proportion of patients with blood pressure<140/90 mmHg at 12 weeks.
Measured: 12 weeks.
Secondary outcomes (5)
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.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks.
Change of serum potassium level
Change of serum potassium level (mmol/L)
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks.
Changes of plasma renin activity and ARR.
Measured: 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.
- Adverse effects such as gynaecomastia, mastodynia, menstrual abnormalities and impotence due to its agonist activity.
- Hyperkalemia.
- Other adverse events.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks.
Proportion of patients with normal serum.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study startMay 2023 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary AldosteronismStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Key Research and Development Program of China, National Natural Science Foundation of China
- Responsible party
- Sponsor
- Investigators
- Ping Li, Study director, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05814770
- Sponsor's protocol ID
- PA2023
- Status last verified
- Mar 2023
- First submitted
- 13 Mar 2023
- Last updated
- 18 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05814770
- Acronym / sponsor ID
- PA2023
- Conditions
- Primary Aldosteronism, Hypertension
- Keywords
- primary aldosteronism, hypertension, finerenone, spironolactone, treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Collaborators
- National Key Research and Development Program of China, National Natural Science Foundation of China
- Study start
- May 2023 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Finerenone | Experimental | Drug: Finerenone |
| Spironolactone | Active comparator | Drug: Spironolactone |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FinerenoneAlso: KerendiaThe 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 | Finerenone |
| SpironolactoneThe 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. | Drug | Spironolactone |
Primary outcome
Hypertension remission rate.
Time frame: 12 weeks.
The proportion of patients with blood pressure<140/90 mmHg at 12 weeks.
5 secondary outcomes
The change of systolic and diastolic BP from the baseline level.
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks.
Change of serum potassium level
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks.
Changes of plasma renin activity and ARR.
Time frame: 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.
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks.
Proportion of patients with normal serum.
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
Related trials for Primary Aldosteronism
Not yet recruitingPhase 2
SYH2072 Tablets in Participants With Primary Aldosteronism
Primary Aldosteronism
Recruiting
Trial of Aldosterone-hybrid SteRoid for Guiding curablE Treatment of Primary Aldosteronism (TARGET-PA)
Hyperaldosteronism; Primary, Primary Aldosteronism Due to Aldosterone Producing Adenoma
RecruitingObservational study
Kidney Stiffness Measured by Ultrasound in Patients With High Blood Pressure and Healthy Volunteers
Arterial Hypertension, Chronic Kidney Disease, Primary Aldosteronism
Active, not recruiting
Electronic Alert to Improve Testing For Primary Aldosteronism in Patients With Hypertension
Primary Aldosteronism, Resistant Hypertension
Active, not recruiting
Randomised Trial Comparing Thermal Ablation With Adrenalectomy in the Treatment of Unilateral Asymmetric PA
Primary Aldosteronism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ping Li study director
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Finerenone and Spironolactone in people with Primary Aldosteronism and Hypertension, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ping Li, Ph.D (86-025-83106666, li78321@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypertension remission rate. (time frame: 12 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.