Clinical trial NCT05814770: 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
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Primary Aldosteronism
Hypertension
Keywords: primary aldosteronism
hypertension
finerenone
spironolactone
treatment
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
Collaborators: name: National Key Research and Development Program of China
name: National Natural Science Foundation of China
First posted: 2023-04-18
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Hypertension remission rate.
timeFrame: 12 weeks.
Secondary outcomes:
measure: The change of systolic and diastolic BP from the baseline level.
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks.
measure: Change of serum potassium level
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks.
measure: Changes of plasma renin activity and ARR.
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks.
measure: Incidence of Treatment-Adverse Events as assessed by gynaecomastia, mastodynia, menstrual abnormalities, impotence, hyperkalemia and other adverse events.
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks.
measure: Proportion of patients with normal serum.
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks.
Other outcomes:
Locations:
Study officials:
affiliation: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: Ping Li
role: STUDY_DIRECTOR
References: