Health TrialsbyHealthPanel

Spironolactone to Improve Pregnancy-Associated Hypertension Trajectories

ConditionsPreeclampsiaGestational Hypertension
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMassachusetts General Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • spironolactone 25 mg orally once daily

    Drug

    Participants with hypertensive disorders of pregnancy will receive 25mg capsules of spironolactone to self-administer daily over the 12-week duration of the study treatment.

  • Placebo tablet to match spironolactone

    Drug

    Participants with Hypertensive disorders of pregnancy will receive placebo equivalent capsules to self-administer daily over the 12-week duration of the study treatment.

Treatment groups

204 Participants
are divided into 2 treatment groups
Group A: Placebo: ControlPlacebo comparator 1 intervention
Group B: Treatment: SpironolactoneExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Mean 24-hour ambulatory diastolic blood pressure

24-hour BP monitoring will be performed as part of end-of-study assessments using a validated ambulatory BP monitor.

Time frame
36 weeks

Secondary outcomes

1

Left ventricular relative wall thickness (main echocardiographic outcome)

Relative wall thickness is calculated as 2\*posterior wall thickness/LV end-diastolic diameter as measured by transthoracic echocardiography.

Time frame
Baseline and 36 weeks
2

Mean 24-hour ambulatory systolic blood pressure

24-hour BP monitoring will be performed as part of end-of-study assessment using a validated ambulatory BP monitor. Mean 24-hour systolic BP will be calculated from the device data.

Time frame
36 weeks
3

Mean diurnal ambulatory systolic blood pressure

24-hour BP monitoring will be performed as part of the end-of-study assessment using a validated ambulatory BP monitor. Mean diurnal systolic BP will be calculated from the device data.

Time frame
36 weeks
4

Mean diurnal ambulatory diastolic blood pressure

24-hour BP monitoring will be performed as part of the end-of-study assessment using a validated ambulatory BP monitor. Mean diurnal ambulatory diastolic blood pressure will be calculated from the device data

Time frame
36 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts General Hospital

Lead sponsor

Brigham and Women's Hospital

Collaborator

University of Pittsburgh Medical Center

Collaborator

Source ClinicalTrials.gov
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