An observational study in Hyperaldosteronism Primary, sponsored by Central Hospital, Nancy, France. Not yet recruiting. Per ClinicalTrials.gov, last updated 2025-08-12.
Sponsored by Central Hospital, Nancy, France · Observational
Primary hyperaldosteronism is characterised by excessive and autonomous aldosterone secretion by the adrenal glands, independent of renin. The condition is characterised by an aldosterone-to-renin ratio (ARR) that exceeds a certain pathological threshold. It manifests as arterial hypertension, which is potentially associated with hypokalaemia due to increased urinary potassium excretion. Excessive and unregulated aldosterone secretion is a validated risk factor for cardiovascular complications.
Primary hyperaldosteronism is estimated to account for 5-20% of hypertension cases and up to 25% of resistant hypertension cases.
Autonomous aldosterone secretion may originate from unilateral secretion by a benign adrenal cortical tumour (Conn's adenoma). Treatment usually involves surgical removal of the hypersecretion source via unilateral adrenalectomy. Alternatively, it can correspond to bilateral adrenal secretion, with or without lateralisation (bilateral adrenal hyperplasia), which is typically managed with antihypertensive medications and/or mineralocorticoid receptor antagonists. In 2021, the HISTOALDO consensus (histology of primary aldosteronism) and the routine use of immunohistochemistry (CYP11B2) made it possible to describe all the histopathological variations between a simple cortical adrenal tumour and bilateral hyperplasia.
Primary hyperaldosteronism due to unilateral or bilateral lesions with lateralised secretion (confirmed by venous sampling or NP53 scintigraphy) usually warrants surgical management via adrenalectomy.
However, while the effectiveness of the treatment is almost guaranteed to cure hypokalaemia, blood pressure changes after surgery remain highly variable, with few criteria available to predict the impact of surgery on blood pressure. Some patients are completely cured and can discontinue all antihypertensive medications, while others experience improvement, allowing a reduction in treatment. A final group shows no change in blood pressure post-adrenalectomy.
The main objective of this study is to evaluate the predictive value of measuring hormone status (aldosterone, renin and ARR) on the first day after surgery for postoperative blood pressure outcomes (clinical criteria: Systolic Blood Pressure).
201 studies on the registry are indexed under Hyperaldosteronism; 93 are open to participants now.
This study's planned enrollment of 110 is below the median of 200 across 103 observational studies indexed under Hyperaldosteronism.
Browse Hyperaldosteronism studies →Central Hospital, Nancy, France is the lead sponsor of 798 studies on the registry; 186 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients who underwent unilateral adrenalectomy for primary hyperaldosteronism between 2017 and 2025.
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Exclusion Criteria:
-none
To evaluate the predictive value of the evolution of the ARR between the preoperative period and Day 1 post-surgery on clinical blood pressure outcome
To evaluate the the evolution of the ARR between the preoperative period and Day 1 post-surgery predicts the clinical blood pressure outcome (clinical PASO criteria) observed two months after unilateral adrenalectomy for lateralized primary hyperald
Time frame: 2-3 months
To evaluate the predictive value of ARR on Day 1 following unilateral adrenalectomy for primary hyperaldosteronism on clinical blood pressure outcome (clinical PASO criteria)
Time frame: 2-3 months
To evaluate the predictive value of aldosterone levels on Day 1 following unilateral adrenalectomy for primary hyperaldosteronism on clinical blood pressure outcome (clinical PASO criteria)
Time frame: 2-3 months
To evaluate the predictive value of renin levels on Day 1 following unilateral adrenalectomy for primary hyperaldosteronism on clinical blood pressure outcome (clinical PASO criteria)
Time frame: 2-3 months
To determine whether intraoperative blood pressure variations during unilateral adrenalectomy for primary hyperaldosteronism predict postoperative clinical blood pressure outcome (clinical PASO criteria)
Time frame: 2-3 months
To identify patient-related factors associated with postoperative clinical blood pressure outcome (clinical PASO criteria)
Time frame: 2-3 months
To identify histopathological factors associated with postoperative clinical blood pressure outcome (clinical PASO criteria)
Time frame: 2-3 months
No study locations are listed for this record.
Plan to share: Undecided
Start is estimated for Aug 2025; primary completion for Oct 2025, 2 months later.
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This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Central Hospital, Nancy, France →