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New treatment option for Primary Aldosteronism
Official title REnin-guided TherApy With MinEralocorticoid Receptor Antagonists in Primary Aldosteronism - Feasibility Study
ClinicalTrials.gov ID: NCT06108427
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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 likely can't join 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
See the full eligibility criteria
- 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Montreal, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montreal, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.