Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2026-01-01 @ 7:27 AM
Study NCT ID:
NCT05636995
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-01-15
First Post:
2022-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HyperAldosteronism in Pregnancy Predicted Impacts (H.A.P.P.I. Trial)
Sponsor:
Université de Sherbrooke
Organization:
Study Overview
Official Title:
HyperAldosteronism in Pregnancy Predicted Impacts
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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:
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:
1. to compare maternal, fetal and neonatal outcomes among women diagnosed with primary hyperaldosteronism (PHA) and pregnant women without PHA.
2. to establish the prevalence of PHA for each sub-type of hypertensive disorder of pregnancy
3. to compare maternal, fetal and neonatal outcomes among women diagnosed with primary hyperaldosteronism (PHA) before pregnancy and pregnant women diagnosed with PHA after pregnancy.
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:
1. to compare maternal, fetal and neonatal outcomes among women diagnosed with primary hyperaldosteronism (PHA) and pregnant women without PHA.
2. to establish the prevalence of PHA for each sub-type of hypertensive disorder of pregnancy
3. to compare maternal, fetal and neonatal outcomes among women diagnosed with primary hyperaldosteronism (PHA) before pregnancy and pregnant women diagnosed with PHA after pregnancy.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: