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REnin-guided TherApy With MinEralocorticoid Receptor Antagonists in Primary Aldosteronism - Feasibility Study

RecruitingNAAges 18 Years - anyAllCentre Integre Universitaire de Sante et Services…
NCT06108427 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

High blood pressure, or hypertension, can be caused by a condition called Primary Aldosteronism (PA), where the body produces too much of a hormone called aldosterone. People with PA have a higher risk of heart problems compared to those with regular high blood pressure. To treat PA, some patients need to take medicine called mineralocorticoid receptor antagonists (MRA) for the rest of their lives. While treatment with MRA is effective, it can have side effects like high levels of potassium in the blood, breast enlargement in men, menstrual problems in women, and reduced sex drive. Finding the right dose of MRA for each patient can be tricky. Recent observations suggest that when a hormone called renin goes up during MRA treatment, it might be a good sign. This is because renin is higher when the action of aldosterone is well blocked. But it's not certain if this happens because of the

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📋 Eligibility rules (as published)
Inclusion Criteria: * Over 18 years of age * Diagnosis of PA, in accordance with clinical guidelines and local practice * Suppressed plasma renin prior to treatment initiation (plasma renin concentration \>15 mIU/L or \>10 ng/L, or plasma renin activity \>1 ng/mL/h) * Planned long-term treatment with mineralocorticoid receptor antagonist Exclusion Criteria: * Prior use of mineralocorticoid receptor antagonist or any potassium-sparing diuretics in the past 3 months * Known intolerance or contraindication to mineralocorticoid receptor antagonist treatment * eGFR \< 30 ml/min/1.73m2 (past 3 months) * Baseline serum potassium above \> 4.8 mmol/L (past 3 months) * Deemed medically unsafe to stop medications for the initiation of MRA as monotherapy * Pregnancy or breastfeeding * Participation in another study that is likely to affect renin or BP levels * Inability to provide consent due to cognitive impairment and/or language barrier.
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What it tests

  • Renin measurements
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Where

1 site
Hôpital du Sacré-Coeur de Montréal
Montreal, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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