Status:
RECRUITING
REnin-guided TherApy With MinEralocorticoid Receptor Antagonists in Primary Aldosteronism - Feasibility Study
Lead Sponsor:
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
Conditions:
Primary Aldosteronism
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ris...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT06108427
Start Date
April 25 2024
End Date
September 1 2027
Last Update
July 18 2024
Active Locations (1)
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1
Hôpital du Sacré-Coeur de Montréal
Montreal, Quebec, Canada, H4J1C5