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 range18 Years – 75 Years
SexALL
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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: ①After 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).
✓. Signed informed consent form.
Exclusion criteria
✕. 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.
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