HyperAldosteronism in Pregnancy Predicted Impacts (H.A.P.P.I. Trial)

Study Overview
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Brief Summary
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Primary hyperaldosteronism confers a higher risk of cardiovascular complications compared to essential hypertension. Preliminary data is controversial in regards of excessive maternal fetal and neonatal excessive risks in pregnancy. This study aims at establishing the prevalence of PHA in an population with a recent episode of hypertensive disorder of pregnancy (HDP). The goal is to determine if a universal screening for PHA after a HDP is worthed. The investigators also wish to evaluate the complication rate in pregnant women with PHA compared to women without PHA. This is a prospective cohort study where all eligible women will be screened for PHA after a HDP episode in the last pregnancy. We will then compare PHA women to non PHA women according to pregnancy complications.

Detailed Description
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This is a pilot study to evaluate feasibility and proof of concept. This is a prospective multicenter cohort study. Two university centers will participate (Sherbrooke and Montreal). Participants will be recruited from post-partum Obstetric Medicine clinic in two tertiary care centers. They will be included if they presented a hypertensive disorder of preganncy (HDP) in their last pregnacy (from 4 weeks to 24 months after delivery). Women with pheochromocytoma, Cushing syndrome, secondary hyperaldosteronism, and those who are currently pregnant will be excluded. All participants will be screened for PHA (with an aldosterone/renin ratio) and if the screening test is positive, they will be referred to a specialist to confirm the diagnosis. Data will be collected from the participants and their babies' charts. Demographic data, obstetrical data, delivery data, maternal/fetal/neonatal complications, and diagnostic of PHA data will be collected. A convenient sample size of 200 women will be used. If the prevalence of HPA is 5% or more, this would justify a larger study. Primary outcome: establish the prevalence of PHA in women with a hypertensive disorders of pregnancy in last pregancy. Secondary outcome include: to compare maternal, fetal and neonatal outcomes among women diagnosed with primary hyperaldosteronism (PHA) and pregnant women without PHA. to establish the prevalence of PHA for each sub-type of hypertensive disorder of pregnancy to compare maternal, fetal and neonatal outcomes among women diagnosed with primary hyperaldosteronism (PHA) before pregnancy and pregnant women diagnosed with PHA after pregnancy.

Official Title
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HyperAldosteronism in Pregnancy Predicted Impacts

Conditions
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Primary Hyperaldosteronism, Hypertensive Disorder of Pregnancy

Intervention / Treatment
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* Diagnostic Test: Aldosterone/Renin Ratio


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between 4 and 24 weeks post-partum women who had a hypertensive disorder during their latest pregnancy. Exclusion Criteria: Ongoing pregnancy Diagnosed pheochromocytoma Diagnosed Cushing syndrome Diagnosed secondary hyperaldosteronism

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Primary Hyperaldosteronism Diagnosed Women<br>Post-partum women who had a hypertensive disorder of pregnancy and a screened primary hyperaldosteronism (positive aldosterone/renin ratio). | Diagnostic Test: Aldosterone/Renin Ratio<br>* Blood sample collected to measure the aldosterone/renin ratio for the primary hyperaldosteronism screening.<br>|
| Control Women<br>Post-partum women who had a hypertensive disorder of pregnancy without underlying primary hyperaldosteronism (negative aldosterone/renin ratio) | Diagnostic Test: Aldosterone/Renin Ratio<br>* Blood sample collected to measure the aldosterone/renin ratio for the primary hyperaldosteronism screening.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary hyperaldosteronism (PHA) prevalence in pregnant women with hypertensive disorders of pregnancy. | Prevalence of PHA in women with a hypertensive disorder of pregnancy in last pregnancy | Screening done between 4 and 24 weeks post-partum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal and fetal impacts of PHA on hypertensive disorders of pregnancy | Comparison of the prevalence of each pre-specified complications (obstetrical, maternal, fetal, neonatal) between the PHA group and the non-PHA group. | During last pregnancy and 6 weeks postpartum | 
| Prevalence of PHA for each hypertensive disorder of pregnancy | Comparison of the prevalence of each HDP subtype (i.e. chronic hypertension, gestational hypertension, pre-eclampsia) | During last pregnancy and 6 weeks postpartum | 
| Impact of the timing of PHA on hypertensive disorders of pregnancy | Comparison between pregnancy outcomes for PHA diagnosed before the pregnancy with those diagnosed in post-partum | During last pregnancy and 6 weeks postpartum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy Outcome, Prevalence