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

NCT05636995 | Active Not Recruiting

• 1 other identifier: MP-31-2023-4857
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

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.

Conditions

Primary Hyperaldosteronism; Hypertensive Disorder of Pregnancy

Keywords

Pregnancy Outcome; Prevalence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Maternal and fetal impacts of PHA on hypertensive disorders of pregnancy

  During last pregnancy and 6 weeks postpartum

• Prevalence of PHA for each hypertensive disorder of pregnancy

  During last pregnancy and 6 weeks postpartum

• Impact of the timing of PHA on hypertensive disorders of pregnancy

  During last pregnancy and 6 weeks postpartum

Study Arms (2)

Primary Hyperaldosteronism Diagnosed Women

Post-partum women who had a hypertensive disorder of pregnancy and a screened primary hyperaldosteronism (positive aldosterone/renin ratio).

Diagnostic Test: Aldosterone/Renin Ratio

Control Women

Post-partum women who had a hypertensive disorder of pregnancy without underlying primary hyperaldosteronism (negative aldosterone/renin ratio)

Diagnostic Test: Aldosterone/Renin Ratio

Interventions

Aldosterone/Renin Ratio DIAGNOSTIC_TEST

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

Control Women; Primary Hyperaldosteronism Diagnosed Women

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Post-partum women who are followed in a specialized post-partum clinic in Montreal or Sherbrooke (Qc, Canada) for their hypertensive disorder during their latest pregnancy.

You may qualify if:

• Between 4 and 24 weeks post-partum women who had a hypertensive disorder during their latest pregnancy.

You may not qualify if:

• Ongoing pregnancy
• Diagnosed pheochromocytoma
• Diagnosed Cushing syndrome
• Diagnosed secondary hyperaldosteronism

Sponsors & Collaborators

• Université de Sherbrooke: lead

Study Sites (2)

Centre Hopitalier Universiatire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Related 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.

  PMID: 33393127 BACKGROUND

• 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.

  PMID: 24927294 BACKGROUND

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

  PMID: 28554307 BACKGROUND

• 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.

  PMID: 27682655 BACKGROUND

• 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.

  PMID: 27156905 BACKGROUND

• 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.

  PMID: 35569086 BACKGROUND

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

  PMID: 19171690 BACKGROUND

MeSH Terms

Conditions

Hyperaldosteronism; Toxemia

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases; Infections

Study Officials

• Nadine Sauvé, MD

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 25, 2022
• First Posted: December 5, 2022
• Study Start: January 10, 2023
• Primary Completion: March 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 15, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)