REnin-guided TherApy With MinEralocorticoid Receptor Antagonists in Primary Aldosteronism - Feasibility Study

NCT06108427 | Recruiting

• 1 other identifier: RETAME-PA
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Primary Aldosteronism

Outcome Measures

Primary Outcomes (1)

• 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

  12 months

Secondary Outcomes (18)

• Relative change in renin levels from baseline

  12 months

• Office-based systolic and diastolic BP

  12 months

• Central systolic and diastolic BP

  12 months

• Absolute change in left ventricular mass index from baseline

  12 months

• Defined daily dose of mineralocorticoid receptor antagonists

  12 months

Study Arms (2)

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.

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.

Interventions

Renin measurements OTHER

Use of plasma renin measurements to guide MRA dosing, aiming for plasma renin unsuppression

Renin-guided arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal: lead

Study Sites (1)

Hôpital du Sacré-Coeur de Montréal

Montreal, Quebec, H4J1C5, Canada

RECRUITING

Related Publications (1)

• 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.

  PMID: 41419284 DERIVED

MeSH Terms

Conditions

Hyperaldosteronism

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases

Central Study Contacts

Remi Goupil, MD MSc

CONTACT

1(514)338-2883; remi.goupil@umontreal.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinic

Study Record Dates

• First Submitted: October 25, 2023
• First Posted: October 31, 2023
• Study Start: April 25, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: March 17, 2026

Record last verified: 2026-03

Locations

CA (1)