The Clinical Efficacy and Safety of Finerenone in the Treatment of Primary Aldosteronism (NCT06381323) | Clinical Trial Compass
CompletedPhase 4
The Clinical Efficacy and Safety of Finerenone in the Treatment of Primary Aldosteronism
China55 participantsStarted 2024-03-01
Plain-language summary
The purpose of our research is to clarify the therapeutic efficacy and safety of Finerenone in patients with Primary Aldosteronism and explore the effective clinical predictive indicators of Finerenone in the treatment of Primary Aldosteronism.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age:18-75 years old.
. 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.
. Patients with PA who are eligible for drug treatment.
. 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.
. eGFR ≥60 ml/ (min\*1.73m2).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
24h systolic BP drop value
Timeframe: 12 weeks
Trial details
NCT IDNCT06381323
SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
. Other secondary hypertension (such as renal vascular hypertension, Cushing's syndrome, subclinical Cushing's syndrome, and pheochromocytoma) or hypertensive crisis.
. Orthostatic hypotension.
. Heart failure, acute myocardial infarction, stroke, transient ischemic attack, or other acute cardiovascular events within the past 6 months.
. History of adrenal surgery within the past 6 months.
. History of carotid artery surgery within the past 6 months.
. History of arterial vascular reconstruction surgery within the past 6 months.
. Hospitalization within the past year due to severe hyperkalemia, with serum potassium levels \<2.5 or ≥5.0 mmol/L.
. Abnormal liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \> 2.5× upper limit of normal (ULN), total bilirubin (TBIL) \> 1.5× ULN.