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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
58
Use of plasma renin measurements to guide MRA dosing, aiming for plasma renin unsuppression
Hôpital du Sacré-Coeur de Montréal
Montreal, Quebec, Canada
RECRUITINGProportion 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
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