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Is the Evolution of the Aldosterone-renin Ratio Pre- Versus Post-operative on Day 1 Following Unilateral Adrenalectomy for Primary Hyperaldosteronism Predictive of Blood Pressure Outcomes

Is the Evolution of the Aldosterone-renin Ratio Pre- Versus Post-operative on Day 1 Following Unilateral Adrenalectomy for Primary Hyperaldosteronism Predictive of Blood Pressure Outcomes

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07110155
Acronym
vRAR
Enrollment
110
Registered
2025-08-07
Start date
2025-08-15
Completion date
2026-03-30
Last updated
2025-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperaldosteronism Primary

Keywords

arterial hypertension, unilateral adrenalectomy, aldosterone-to-renin ratio (ARR)

Brief summary

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).

Interventions

None listed

Sponsors

Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Patients who underwent unilateral adrenalectomy for primary hyperaldosteronism between 2017 and 2025.

Exclusion criteria

-none

Design outcomes

Primary

MeasureTime frameDescription
To evaluate the predictive value of the evolution of the ARR between the preoperative period and Day 1 post-surgery on clinical blood pressure outcome2-3 monthsTo 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

Secondary

MeasureTime frame
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)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)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)2-3 months
To identify patient-related factors associated with postoperative clinical blood pressure outcome (clinical PASO criteria)2-3 months
To identify histopathological factors associated with postoperative clinical blood pressure outcome (clinical PASO criteria)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)2-3 months

Contacts

Primary ContactMatthias Hoeffel-Morgenthaler
matt.mhm@sfr.fr+33770058922

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026