The Clinical Efficacy and Safety of Finerenone in the Treatment of Primary Aldosteronism

Launched by THE AFFILIATED NANJING DRUM TOWER HOSPITAL OF NANJING UNIVERSITY MEDICAL SCHOOL · Apr 23, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of a medication called Finerenone for treating a condition known as Primary Aldosteronism, which is a type of high blood pressure caused by too much aldosterone, a hormone that helps regulate blood pressure. The trial aims to find out how well Finerenone works and identify which patients might benefit the most from this treatment.

To be eligible for this trial, participants need to be between 18 and 75 years old, have a history of high blood pressure, and meet specific testing criteria that confirm they have Primary Aldosteronism. The trial is currently looking for new participants, and those who join will receive the study medication and be monitored for their response and any side effects. It's important to know that individuals with certain health conditions, such as severe heart problems or recent surgeries, might not be able to participate. This study could provide valuable information that helps improve treatment options for people with this condition.

Gender

ALL

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.