Finerenone treatment for primary aldosteronism

Study on the Clinical Efficacy and Safety of the New Mineralocorticoid Receptor Antagonist Finerenone in the Treatment of Primary Aldosteronism: a Multicenter, Prospective, Open-label Clinical Study

This study is testing if a new medication called Finerenone can help people with primary aldosteronism manage their high blood pressure better.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 55 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School (Academic / other)
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT06381323 on ClinicalTrials.gov

What this trial studies

This research aims to evaluate the efficacy and safety of Finerenone, a mineralocorticoid receptor antagonist, in patients diagnosed with primary aldosteronism. The study will involve patients aged 18-75 with a history of hypertension and specific diagnostic criteria for primary aldosteronism. Participants will receive Finerenone and undergo monitoring to assess blood pressure and other clinical indicators. The goal is to identify effective predictors for the treatment's success and improve management strategies for this condition.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with confirmed primary aldosteronism and hypertension requiring drug treatment.

Not a fit: Patients with other forms of secondary hypertension or those who do not meet the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a safer and more effective option for managing primary aldosteronism and its associated hypertension.

How similar studies have performed: While there is limited data on Finerenone specifically for primary aldosteronism, the use of mineralocorticoid receptor antagonists has shown promise in managing hypertension in similar conditions.

Eligibility criteria

Inclusion Criteria:

1. Age:18-75 years old.
2. History of hypertension, with a sitting SBP ≥140 and \<180 mmHg, and a sitting DBP ≥90 and \<120 mmHg during the last two evaluations within the observation period.
3. Patients with PA who are eligible for drug treatment.
4. Diagnostic criteria for primary aldosteronism: (1) Hypertension or use of antihypertensive medications, with or without hypokalemia; (2) Screening test: Baseline plasma aldosterone to renin ratio (ARR) \>30 (ng/dl)/(ng/ml/h) or ARR \>2.4 (ng/dl)/(mU/L), with plasma aldosterone \>15 ng/dl and plasma renin activity \<1.0 ng/ml/h; (3) At least one confirmed test is positive: ① After a captopril test, plasma aldosterone decreases by \<30% or plasma aldosterone is ≥11 ng/dl, with suppressed renin activity; ② Sitting saline infusion test results in a plasma aldosterone ≥10 ng/dl.
5. eGFR ≥60 ml/ (min\*1.73m2).
6. Signed informed consent form.

Exclusion Criteria:

1. Other secondary hypertension (such as renal vascular hypertension, Cushing's syndrome, subclinical Cushing's syndrome, and pheochromocytoma) or hypertensive crisis.
2. Orthostatic hypotension.
3. Heart failure, acute myocardial infarction, stroke, transient ischemic attack, or other acute cardiovascular events within the past 6 months.
4. History of adrenal surgery within the past 6 months.
5. History of carotid artery surgery within the past 6 months.
6. History of arterial vascular reconstruction surgery within the past 6 months.
7. Hospitalization within the past year due to severe hyperkalemia, with serum potassium levels \<2.5 or ≥5.0 mmol/L.
8. Abnormal liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \> 2.5× upper limit of normal (ULN), total bilirubin (TBIL) \> 1.5× ULN.
9. Use of spironolactone, hydralazine, or minoxidil within 30 days prior to enrollment.
10. Concurrent use of potent CYP3A4 inhibitors or inducers for treatment.
11. Known or suspected tumors; other autoimmune diseases, uncontrolled infectious diseases, severe respiratory, blood, and neurological diseases.
12. Pregnancy or planning pregnancy within 3 months before or after treatment, and breastfeeding women.
13. Mental illness, alcohol or drug abuse, inability to cooperate with treatment.
14. Patients with pacemakers.
15. Participation in other clinical trials.

Where this trial is running

Nanjing, Jiangsu

• Department of Endocrinology, Drum Tower Hospital affiliated to Nanjing University Medical School — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Ping Li, Ph.D

Conditions Primary Aldosteronism; Finerenone; Mineralocorticoid Receptor Antagonist; Hypertension; 24-hour ambulatory blood pressure monitoring; Daytime SBP