Primary AldosteronismRETAME-PANCT06108427
REnin-guided TherApy With MinEralocorticoid Receptor Antagonists in Primary Aldosteronism - Feasibility Study
A study testing Renin measurements in people with Primary Aldosteronism, run by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal at 1 site in Canada.
Trial 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 risk of heart problems compared to those with regular high blood pressure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Aldosteronism
- What is being tested?
- Renin measurements
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteCanada
- Study dates
- 25 Apr 2024to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Hôpital du Sacré-Coeur de Montréal
Montreal, Quebec, H4J1C5
Guylaine Marcotte
Remi Goupil, MD MSc
About this study
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.
Read more
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.
- Conditions
- Primary Aldosteronism
- Being tested
- Renin measurements
- Medical subject headings
- Hyperaldosteronism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renin measurementsOther
Use of plasma renin measurements to guide MRA dosing, aiming for plasma renin unsuppression
| Study group | Role | What they receive |
|---|---|---|
| Renin-guided arm | Experimental | 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. Receives: Other: Renin measurements |
| Renin-blinded arm | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (18)
Relative change in renin levels from baseline
Relative change in renin levels from baseline
Measured: 12 months
Office-based systolic and diastolic BP
Office-based systolic and diastolic BP
Measured: 12 months
Central systolic and diastolic BP
Central systolic and diastolic BP
Measured: 12 months
Absolute change in left ventricular mass index from baseline
Absolute change in left ventricular mass index from baseline
Measured: 12 months
Defined daily dose of mineralocorticoid receptor antagonists
Defined daily dose of mineralocorticoid receptor antagonists
Measured: 12 months
Defined daily dose of all antihypertensive medications (including mineralocorticoid receptor antagonists)
Defined daily dose of all antihypertensive medications (including mineralocorticoid receptor antagonists)
Measured: 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
Measured: 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
Measured: 12 months
Albumin/creatinine ratio
Albumin/creatinine ratio
Measured: 12 months
Serum potassium levels
Serum potassium levels
Measured: 12 months
Change in eGFR
Change in eGFR
Measured: 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
Measured: 12 months
Acute kidney injury (>50% increase in serum creatinine)
>50% increase in serum creatinine
Measured: 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
Measured: 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
Measured: 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)
Measured: 12 months
All-cause hospitalisation
All-cause hospitalisation
Measured: 12 months
All-cause mortality
All-cause mortality
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start25 Apr 2024
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary AldosteronismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Remi Goupil, MD MSc, Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06108427
- Sponsor's protocol ID
- RETAME-PA
- Acronym
- RETAME-PA
- Status last verified
- Mar 2026
- First submitted
- 25 Oct 2023
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Merabtine A, Leung AA, Kline GA, Dubrofsky L, Hundemer GL, Goupil R. Renin-guided therapy with mineralocorticoid receptor antagonists in primary aldosteronism: feasibility study (RETAME-PA) - a clinical research protocol for a randomised controlled trial. BMJ Open. 2025 Dec 19;15(12):e111167. doi: 10.1136/bmjopen-2025-111167.
PubMed 41419284
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REnin-guided TherApy With MinEralocorticoid Receptor Antagonists in Primary Aldosteronism - Feasibility Study
- ClinicalTrials.gov ID
- NCT06108427
- Acronym / sponsor ID
- RETAME-PA / RETAME-PA
- Conditions
- Primary Aldosteronism
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de MontrealUniversity, hospital or other
- Study start
- 25 Apr 2024 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 31 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Renin-guided arm | Experimental | Other: Renin measurementsRenin 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. |
| Renin-blinded arm | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Renin measurementsUse of plasma renin measurements to guide MRA dosing, aiming for plasma renin unsuppression | Other | Renin-guided arm |
Primary outcome
Proportion of participants with unsuppressed renin
Time frame: 12 months
Proportion of participants with plasma renin concentration >15 mIU/L or >10 ng/L, or plasma renin activity >1 ng/mL/h
18 secondary outcomes
Relative change in renin levels from baseline
Time frame: 12 months
Office-based systolic and diastolic BP
Time frame: 12 months
Central systolic and diastolic BP
Time frame: 12 months
Absolute change in left ventricular mass index from baseline
Time frame: 12 months
Defined daily dose of mineralocorticoid receptor antagonists
Time frame: 12 months
Defined daily dose of all antihypertensive medications (including mineralocorticoid receptor antagonists)
Time frame: 12 months
Health-related quality of life (SF-36 questionnaire)
Time frame: 12 months
Health-related quality of life (primary aldosteronism-specific questionnaire)
Time frame: 12 months
Albumin/creatinine ratio
Time frame: 12 months
Serum potassium levels
Time frame: 12 months
Change in eGFR
Time frame: 12 months
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)
Time frame: 12 months
Number of participants with progression towards kidney 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
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)
Time frame: 12 months
All-cause hospitalisation
Time frame: 12 months
All-cause mortality
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Derived from this study: PubMed 41419284Merabtine A, Leung AA, Kline GA, Dubrofsky L, Hundemer GL, Goupil R. Renin-guided therapy with mineralocorticoid receptor antagonists in primary aldosteronism: feasibility study (RETAME-PA) - a clinical research protocol for a randomised controlled trial. BMJ Open. 2025 Dec 19;15(12):e111167. doi: 10.1136/bmjopen-2025-111167.
Related trials for Primary Aldosteronism
Not yet recruitingPhase 2
SYH2072 Tablets in Participants With Primary Aldosteronism
Primary Aldosteronism
Recruiting
Trial of Aldosterone-hybrid SteRoid for Guiding curablE Treatment of Primary Aldosteronism (TARGET-PA)
Hyperaldosteronism; Primary, Primary Aldosteronism Due to Aldosterone Producing Adenoma
RecruitingObservational study
Kidney Stiffness Measured by Ultrasound in Patients With High Blood Pressure and Healthy Volunteers
Arterial Hypertension, Chronic Kidney Disease, Primary Aldosteronism
Active, not recruiting
Electronic Alert to Improve Testing For Primary Aldosteronism in Patients With Hypertension
Primary Aldosteronism, Resistant Hypertension
Active, not recruiting
Randomised Trial Comparing Thermal Ablation With Adrenalectomy in the Treatment of Unilateral Asymmetric PA
Primary Aldosteronism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Renin measurements in people with Primary Aldosteronism, run by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Remi Goupil, MD MSc (1(514)338-2883, remi.goupil@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with unsuppressed renin (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06108427, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.