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New treatment option for Preeclampsia
Official title Spironolactone to Improve Pregnancy-Associated Hypertension Trajectories
ClinicalTrials.gov ID: NCT07041281
What this study is testing
What is spironolactone 25 mg orally once daily?
spironolactone 25 mg orally once daily is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for preeclampsia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The hypertensive disorders of pregnancy (preeclampsia and gestational hypertension) are associated with increased long-term maternal risk of developing cardiovascular disease. Recent evidence suggests that activation of the mineralocorticoid receptor promotes ongoing susceptibility to hypertension in women following hypertensive disorders of pregnancy.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, 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, women only
You may be able to join if
- Females aged ≥18 years
- HDP (gestational hypertension or preeclampsia) without pre-pregnancy chronic hypertension
- BMI ≥25 kg/m2 prior to pregnancy or in the first trimester
- Requirement for antihypertensive medication within one week of delivery
- Ability to provide informed consent
You likely can't join if
- LV ejection fraction \<50% or history of clinical heart failure with reduced or preserved ejection fraction
- Hypertrophic or other genetic cardiomyopathy
- Hyperkalemia: potassium \>5.3 mEq/L
- BMI at screening ≥50 kg/m2
- Pre-pregnancy diabetes
- Estimated glomerular filtration rate (eGFR) \<60mL/min/1.73 m2
See the full eligibility criteria
- Females aged ≥18 years
- HDP (gestational hypertension or preeclampsia) without pre-pregnancy chronic hypertension
- BMI ≥25 kg/m2 prior to pregnancy or in the first trimester
- Requirement for antihypertensive medication within one week of delivery
- Ability to provide informed consent
- LV ejection fraction \<50% or history of clinical heart failure with reduced or preserved ejection fraction
- Hypertrophic or other genetic cardiomyopathy
- Hyperkalemia: potassium \>5.3 mEq/L
- BMI at screening ≥50 kg/m2
- Pre-pregnancy diabetes
- Estimated glomerular filtration rate (eGFR) \<60mL/min/1.73 m2
- Cirrhosis
- Primary aldosteronism
- Intention to become pregnant within 9 months
- Active substance abuse
- Other serious medical illnesses or concerns about protocol adherence/ mortality within 9 months
- Participation in another treatment clinical study
- Hypersensitivity to spironolactone
- Addison's disease
- Concomitant use of eplerenone or finerenone
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
- Pittsburgh, Pennsylvania, United States
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 female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States; Pittsburgh, Pennsylvania, United States. 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.