Blood pressure breakthrough? Renin-Guided therapy may offer smarter First-Line treatment
NCT ID NCT07687160
First seen Jul 07, 2026 · Last updated Jul 14, 2026 · Updated 3 times
Summary
This study explores whether measuring a hormone called renin can help doctors choose the best first medication for people with early-stage high blood pressure. Adults with low renin levels are randomly assigned to receive either spironolactone or a standard blood pressure drug for 12 weeks. The goal is to see if this renin-guided strategy is practical in primary care and whether spironolactone leads to better blood pressure control.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Spironolactone
- What this could lead to
- If successful, this approach could offer a more personalized, effective first-line treatment for people with low-renin hypertension, potentially reducing cardiovascular risk.
- What could go wrong
- This is a small pilot study with only 30 participants, so results may not apply broadly. Spironolactone can cause side effects like high potassium or kidney issues.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age ≥18 years. 2. Under the care of a primary care clinician in Ontario. 3. Standardized office systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥80 mmHg. 4. Mean daytime baseline ABPM systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥80 mmHg. 5. Treating primary care clinician has independently determined that initiation of antihypertensive pharmacotherapy is clinically indicated. 6. Either: * Not currently receiving antihypertensive therapy, OR * Receiving a single antihypertensive medication (ACE inhibitor, ARB, thiazide/thiazide-like diuretic, or calcium channel blocker) which the treating primary care clinician considers safe to discontinue for a 2-week washout period. 7. Suppressed renin defined as direct renin concentration \<6 ng/L (\<10 mU/L) measured under routine outpatient conditions. Suppressed renin was selected as the primary biologic enrichment criterion because it is the physiologic hallmark of sodium-retaining, aldosterone-mediated hypertension and is more pragmatically scalable in primary care than complex biochemical primary aldosteronism (PA) definitions. 8. In the opinion of the treating primary care clinician, outpatient participation in the study is appropriate. Exclusion Criteria: 1. Standardized office systolic blood pressure \>170 mmHg if untreated OR \>150 mmHg if receiving one antihypertensive medication. 2. Known diagnosis of PA requiring specialist-directed management. 3. Known secondary hypertension requiring disease-specific therapy. 4. Current use of MR antagonists. 5. Known intolerance or contraindication to spironolactone, candesartan, hydrochlorothiazide, or amlodipine. 6. eGFR \<30 mL/min/1.73 m2. 7. Serum potassium ≥5.0 mmol/L. 8. Serum sodium \<135 mmol/L. 9. Pregnancy, breastfeeding, or intention to become pregnant during the study period. Women of childbearing potential must have a negative pregnancy test prior to randomization. 10. Participation in another interventional study likely to affect blood pressure. 11. Inability to provide consent
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Ottawa Nurse Practitioner-Led Clinic
Ottawa, Ontario, K1L 8L8, Canada
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St-Isidore Médical
Saint Isidore, Ontario, K0C 2B0, Canada
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The Ottawa Hospital
Ottawa, Ontario, K1H 7W9, Canada
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Other studies related to the condition(s) this trial covers.
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