An interventional study of Renin measurements in Primary Aldosteronism, sponsored by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-17.
Sponsored by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal · Not applicable, Interventional, and Treatment
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 patient's unique characteristics or if it can truly be a way to know if the treatment is working.
This study aims to find out if guiding MRA treatment with renin levels leads to more patients having unsuppressed renin levels compared to the standard of care.
This is a multicentric pragmatic clinical trial. Patients with a new diagnosis of PA and low renin levels will be asked if there are willing to participate. Those with recent use of MRA, known MRA intolerance, severe kidney problems, or have high potassium levels will not be able to participate.
Participants will be randomized into two groups: one group will have their MRA treatment adjusted based on renin levels (the "renin-guided" group), and the other group won't have renin levels checked during treatment (the "renin-blinded" group). Both groups will aim to have their blood pressure under control and potassium levels in the normal range.
The main outcome is the proportion in each group with unsuppressed renin levels after 12 months. Other outcomes will be tested, such as changes in renin levels, how well the treatment works, and any safety concerns (like potassium levels, kidney function, side effects, and blood pressure changes). Different groups of patients will also be looked at separately, like men and women, different ages, races, and initial renin levels, to see if the approach works better for some people.
This study will help find a safe and effective way to treat PA with MRA. Choosing the right dose of MRA is important to adequately block aldosterone but also to avoid side effects.
201 studies on the registry are indexed under Hyperaldosteronism; 93 are open to participants now.
This study's planned enrollment of 58 is close to the median of 63 across 94 interventional studies indexed under Hyperaldosteronism.
Browse Hyperaldosteronism studies →Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal is the lead sponsor of 34 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Renin levels will be measured prior to each follow-up appointment and MRA therapy will be titrated to achieve renin unsuppression and normokalemia. Once this is achieved, any other class of antihypertensive drugs mais be used to achieve normal BP levels.
Other: Renin measurements
No measurements of renin levels will be allowed during follow-up. MRA therapy will be titrated to achieve normokalemia. Once this is achieved, any other class of antihypertensive drugs mais be used to achieve normal BP levels.
Use of plasma renin measurements to guide MRA dosing, aiming for plasma renin unsuppression
Proportion of participants with unsuppressed renin
Proportion of participants with plasma renin concentration \>15 mIU/L or \>10 ng/L, or plasma renin activity \>1 ng/mL/h
Time frame: 12 months
Relative change in renin levels from baseline
Relative change in renin levels from baseline
Time frame: 12 months
Office-based systolic and diastolic BP
Office-based systolic and diastolic BP
Time frame: 12 months
Central systolic and diastolic BP
Central systolic and diastolic BP
Time frame: 12 months
Absolute change in left ventricular mass index from baseline
Absolute change in left ventricular mass index from baseline
Time frame: 12 months
Defined daily dose of mineralocorticoid receptor antagonists
Defined daily dose of mineralocorticoid receptor antagonists
Time frame: 12 months
Defined daily dose of all antihypertensive medications (including mineralocorticoid receptor antagonists)
Defined daily dose of all antihypertensive medications (including mineralocorticoid receptor antagonists)
Time frame: 12 months
Health-related quality of life (SF-36 questionnaire)
Health-related quality of life (SF-36 questionnaire): Score of 0 to 100 with highest better
Time frame: 12 months
Health-related quality of life (primary aldosteronism-specific questionnaire)
Health-related quality of life (primary aldosteronism-specific questionnaire): Score of 0 to 112 with highest worse
Time frame: 12 months
Albumin/creatinine ratio
Albumin/creatinine ratio
Time frame: 12 months
Serum potassium levels
Serum potassium levels
Time frame: 12 months
Change in eGFR
Change in eGFR
Time frame: 12 months
Proportion of participants with MRA discontinuation, switch or dose-reduction due to side effects or hyperkalemia
Proportion of participants with MRA discontinuation, switch or dose-reduction due to side effects or hyperkalemia
Time frame: 12 months
Acute kidney injury (>50% increase in serum creatinine)
\>50% increase in serum creatinine
Time frame: 12 months
Number of participants with progression towards kidney failure
Number of participants with sustained eGFR loss ≥ 40%, kidney replacement therapy or death from renal failure
Time frame: 12 months
Number of participants with symptomatic orthostatic hypotension, dizziness, light headedness, injurious falls, syncope or any unexpected event that the attending physician believes could be attributed to the intervention
Number of participants with symptomatic orthostatic hypotension, dizziness, light headedness, injurious falls, syncope or any unexpected event that the attending physician believes could be attributed to the intervention
Time frame: 12 months
Number of participants with cardiovascular adverse events: cardiovascular mortality, myocardial infarction, stroke, heart failure requiring hospitalisation, peripheral artery disease requiring revascularisation (composite and individual categories)
Number of participants with cardiovascular adverse events: cardiovascular mortality, myocardial infarction, stroke, heart failure requiring hospitalisation, peripheral artery disease requiring revascularisation (composite and individual categories)
Time frame: 12 months
All-cause hospitalisation
All-cause hospitalisation
Time frame: 12 months
All-cause mortality
All-cause mortality
Time frame: 12 months
Started Apr 2024 (actual). Primary completion is estimated for Sep 2027, 41 months after the start.
Of 35 interventional studies with no phase under Hyperaldosteronism, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 59. This study's planned 41 months is above that.
How these figures are worked out, and which studies are left out of them.
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Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal