Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05636995

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Primary Hyperaldosteronism Adrenal Gland Diseases Adrenocortical Hyperfunction Endocrine System Diseases Hyperaldosteronism Hypertensive Disorder of Pregnancy Infections Toxemia

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Centre Hopitalier Universiatire de Sherbrooke, Sherbrooke, Quebec, Canada

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aldosterone/Renin Ratio

Diagnostic Test

Blood sample collected to measure the aldosterone/renin ratio for the primary hyperaldosteronism screening.

Primary outcomes

  1. Primary hyperaldosteronism (PHA) prevalence in pregnant women with hypertensive disorders of pregnancy.

    Time frame: Screening done between 4 and 24 weeks post-partum

    Prevalence of PHA in women with a hypertensive disorder of pregnancy in last pregnancy

Secondary outcomes

  1. Maternal and fetal impacts of PHA on hypertensive disorders of pregnancy

    Time frame: During last pregnancy and 6 weeks postpartum

    Comparison of the prevalence of each pre-specified complications (obstetrical, maternal, fetal, neonatal) between the PHA group and the non-PHA group.

  2. Prevalence of PHA for each hypertensive disorder of pregnancy

    Time frame: During last pregnancy and 6 weeks postpartum

    Comparison of the prevalence of each HDP subtype (i.e. chronic hypertension, gestational hypertension, pre-eclampsia)

  3. Impact of the timing of PHA on hypertensive disorders of pregnancy

    Time frame: During last pregnancy and 6 weeks postpartum

    Comparison between pregnancy outcomes for PHA diagnosed before the pregnancy with those diagnosed in post-partum

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Registry information

Official study title

HyperAldosteronism in Pregnancy Predicted Impacts

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 5, 2022
Registry last updated
Jan 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.