Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Female
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
204 (estimated)
Sponsor
Massachusetts General Hospital · Other
Who this trial is looking for
This trial is looking for women who had high blood pressure during pregnancy. Participants will take a medication called spironolactone for three months after giving birth to see how it affects their blood pressure nine months later.
Are You a Good Fit for This Trial?
Rules you outAddison's diseasePrimary aldosteronismActive substance abuseSerious medical illnesses affecting adherence
You may be able to join if
I am a female aged 18 or older
I had high blood pressure during my pregnancy
I have a body mass index (BMI) of 25 or higher before or early in my pregnancy
I needed blood pressure medication within a week of giving birth
I can provide informed consent
You may not be able to join if
I have heart problems or heart failure
I have a history of certain genetic heart diseases
I have high potassium levels in my blood
My BMI is 50 or higher
I had diabetes before my pregnancy
My kidney function is low
I have liver cirrhosis
I intend to become pregnant within the next 9 months
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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. In addition, women with overweight/obesity ar…
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. In addition, women with overweight/obesity are at increased risk for progression to chronic hypertension after experiencing hypertensive disorders of pregnancy. Among women with hypertensive disorders of pregnancy and pre-pregnancy overweight/obesity, the investigators will conduct a randomized trial to test the effect of pharmacologically blocking the mineralocorticoid receptor for three months after delivery on blood pressure and cardiac remodeling at nine months postpartum.
Trial Locations
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Eligibility Criteria
Inclusion 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 inform…
Inclusion 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
Exclusion Criteria:
* 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 interventional clinical study
* Hypersensitivity to spironolactone
* Addison's disease
* Concomitant use of eplerenone or finerenone
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