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

Hypertensive Disorder of Pregnancy Clinical Trial

Official title:

HyperAldosteronism in Pregnancy Predicted Impacts

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05636995
• Other study ID #: MP-31-2023-4857
• Status: Recruiting
• Start date: January 10, 2023
• Est. completion date: December 2024

Study information

• Verified date: November 2023
• Source: Université de Sherbrooke
• Contact: Nadine Sauvé, MD
• Phone: 819-346-1110
• Email: nadine.sauve[@]usherbrooke.ca
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperaldosteronism
• Hypertension
• Hypertensive Disorder of Pregnancy
• Primary Hyperaldosteronism
• Toxemia

Intervention

Diagnostic Test:
• Aldosterone/Renin Ratio
Blood sample collected to measure the aldosterone/renin ratio for the primary hyperaldosteronism screening.

Locations

Country	Name	City	State
Canada	Centre Hopitalier Universiatire de Sherbrooke	Sherbrooke	Quebec
Canada	Centre Hospitalier Universitaire de Sherbrooke	Sherbrooke	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Université de Sherbrooke	Foundation of the Stars

Country where clinical trial is conducted

Canada, 

References & Publications (7)

Alam S, Kandasamy D, Goyal A, Vishnubhatla S, Singh S, Karthikeyan G, Khadgawat R. High prevalence and a long delay in the diagnosis of primary aldosteronism among patients with young-onset hypertension. Clin Endocrinol (Oxf). 2021 Jun;94(6):895-903. doi: 10.1111/cen.14409. Epub 2021 Feb 22. — View Citation

Downie E, Shanmugalingam R, Hennessy A, Makris A. Assessment and Management of Primary Aldosteronism in Pregnancy: A Case-Control Study. J Clin Endocrinol Metab. 2022 Jul 14;107(8):e3152-e3158. doi: 10.1210/clinem/dgac311. — View Citation

Escher G. Hyperaldosteronism in pregnancy. Ther Adv Cardiovasc Dis. 2009 Apr;3(2):123-32. doi: 10.1177/1753944708100180. Epub 2009 Jan 26. — View Citation

Landau E, Amar L. Primary aldosteronism and pregnancy. Ann Endocrinol (Paris). 2016 Jun;77(2):148-60. doi: 10.1016/j.ando.2016.04.009. Epub 2016 May 6. — View Citation

Magee LA, Pels A, Helewa M, Rey E, von Dadelszen P; Canadian Hypertensive Disorders of Pregnancy Working Group. Diagnosis, evaluation, and management of the hypertensive disorders of pregnancy: executive summary. J Obstet Gynaecol Can. 2014 May;36(5):416-41. doi: 10.1016/s1701-2163(15)30588-0. English, French. — View Citation

Turner K, Hameed AB. Hypertensive Disorders in Pregnancy Current Practice Review. Curr Hypertens Rev. 2017;13(2):80-88. doi: 10.2174/1573402113666170529110024. — View Citation

Umesawa M, Kobashi G. Epidemiology of hypertensive disorders in pregnancy: prevalence, risk factors, predictors and prognosis. Hypertens Res. 2017 Mar;40(3):213-220. doi: 10.1038/hr.2016.126. Epub 2016 Sep 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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