Renin-Guided MRA Therapy for Primary Aldosteronism
(RETAME-PA Trial)
Trial Summary
What is the purpose of this trial?
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.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop your current medications, but you cannot have used mineralocorticoid receptor antagonists or potassium-sparing diuretics in the past 3 months. It's best to discuss your current medications with the trial team.
What data supports the effectiveness of the drug for primary aldosteronism?
Research shows that mineralocorticoid receptor antagonists (MRAs), like those used in the treatment, can help lower blood pressure and reduce cardiovascular risks in patients with primary aldosteronism. Additionally, MRAs have been shown to improve vascular function, which is important for heart health.12345
Is Renin-Guided MRA Therapy for Primary Aldosteronism safe for humans?
Mineralocorticoid receptor antagonists (MRAs), like eplerenone and spironolactone, have been used safely in humans for conditions like heart failure and high blood pressure, though they can sometimes cause high potassium levels. Newer nonsteroidal MRAs, such as AZD9977 and finerenone, have shown to be generally well-tolerated with fewer risks of high potassium, making them potentially safer options.24567
How does the drug Aldactone differ from other treatments for primary aldosteronism?
Aldactone (spironolactone) is unique because it uses renin measurements to guide its dosage, aiming to optimize treatment by targeting unsuppressed renin levels, which can help reduce blood pressure and proteinuria in primary aldosteronism patients. This approach is different from standard treatments that do not typically use renin levels to adjust therapy.23489
Research Team
Eligibility Criteria
Adults diagnosed with Primary Aldosteronism who need long-term treatment with mineralocorticoid receptor antagonists (MRA) can join. They must have low renin levels and not be pregnant, breastfeeding, or have used MRA recently. People with severe kidney issues, high potassium levels, or those unable to consent are excluded.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive MRA therapy, with adjustments based on renin levels for the renin-guided group, and without renin level checks for the renin-blinded group
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of renin levels, blood pressure, and side effects
Treatment Details
Interventions
- Renin measurements (Other)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
Lead Sponsor