Using renin levels to guide treatment with mineralocorticoid receptor antagonists for Primary Aldosteronism
REnin-guided TherApy With MinEralocorticoid Receptor Antagonists in Primary Aldosteronism - Feasibility Study
NA · Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal · NCT06108427
This study is testing if measuring renin levels can help doctors adjust the treatment for adults with Primary Aldosteronism who are taking a specific medication to improve their results and reduce side effects.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 58 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal (other) |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT06108427 on ClinicalTrials.gov |
What this trial studies
This study investigates the feasibility of using renin measurements to guide the treatment of patients with Primary Aldosteronism (PA) who are prescribed mineralocorticoid receptor antagonists (MRA). It aims to determine if elevated renin levels during MRA treatment can indicate effective aldosterone blockade and help tailor dosing for individual patients. The study will include adults diagnosed with PA who are starting long-term MRA therapy, while monitoring their renin levels to assess treatment response. The goal is to improve treatment outcomes and minimize side effects associated with MRA therapy.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old diagnosed with Primary Aldosteronism who are starting long-term treatment with mineralocorticoid receptor antagonists.
Not a fit: Patients who have previously used mineralocorticoid receptor antagonists or have contraindications to this treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more personalized and effective treatment for patients with Primary Aldosteronism, reducing side effects and improving overall health outcomes.
How similar studies have performed: While the use of renin levels to guide treatment is a novel approach, similar studies have shown promise in optimizing treatment for conditions related to hormone imbalances.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Montreal, Quebec
- Hôpital du Sacré-Coeur de Montréal — Montreal, Quebec, Canada (RECRUITING)
Study contacts
- Study coordinator: Remi Goupil, MD MSc
- Email: remi.goupil@umontreal.ca
- Phone: 1(514)338-2883
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Primary Aldosteronism