HyperAldosteronism in Pregnancy Predicted Impacts (H.A.P.P.I. Trial)
NCT ID: NCT05636995
Last Updated: 2025-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
200 participants
OBSERVATIONAL
2023-01-10
2025-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Renin and Aldosterone Levels in the Preterm Neonate At Risk for Hypertension
NCT01549444
Cardiovascular an Echocardiographic Assessment in Hypertension During Pregnancy
NCT01068002
Hypertensive and Normal Pregnancy--Calcium Metabolism and Renin-Angiotensin - SCOR in Hypertension
NCT00005456
Chronic Remote Ischemic Preconditioning as a Complement to Conventional Prenatal Care for Preeclampsia
NCT05564988
First-trimester Prediction of Preeclampsia
NCT02189148
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Primary Hyperaldosteronism Diagnosed Women
Post-partum women who had a hypertensive disorder of pregnancy and a screened primary hyperaldosteronism (positive aldosterone/renin ratio).
Aldosterone/Renin Ratio
Blood sample collected to measure the aldosterone/renin ratio for the primary hyperaldosteronism screening.
Control Women
Post-partum women who had a hypertensive disorder of pregnancy without underlying primary hyperaldosteronism (negative aldosterone/renin ratio)
Aldosterone/Renin Ratio
Blood sample collected to measure the aldosterone/renin ratio for the primary hyperaldosteronism screening.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Aldosterone/Renin Ratio
Blood sample collected to measure the aldosterone/renin ratio for the primary hyperaldosteronism screening.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Diagnosed pheochromocytoma
* Diagnosed Cushing syndrome
* Diagnosed secondary hyperaldosteronism
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Université de Sherbrooke
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Nadine Sauvé
Principal investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Nadine Sauvé, MD
Role: PRINCIPAL_INVESTIGATOR
Université de Sherbrooke
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Centre Hopitalier Universiatire de Sherbrooke
Sherbrooke, Quebec, Canada
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Turner K, Hameed AB. Hypertensive Disorders in Pregnancy Current Practice Review. Curr Hypertens Rev. 2017;13(2):80-88. doi: 10.2174/1573402113666170529110024.
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.
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.
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.
Escher G. Hyperaldosteronism in pregnancy. Ther Adv Cardiovasc Dis. 2009 Apr;3(2):123-32. doi: 10.1177/1753944708100180. Epub 2009 Jan 26.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MP-31-2023-4857
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.