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

NCT07110155 | Not Yet Recruiting

• 1 other identifier: 2025PI029
• Study Type: observational
• Target: 110
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Hyperaldosteronism Primary

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

  2-3 months

Secondary Outcomes (6)

• 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 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 determine whether intraoperative blood pressure variations during unilateral adrenalectomy for primary hyperaldosteronism predict postoperative 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

Study Arms (1)

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• none

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Related Publications (4)

• Vignaud T, Baud G, Nomine-Criqui C, Donatini G, Santucci N, Hamy A, Lifante JC, Maillard L, Mathonnet M, Chereau N, Pattou F, Caiazzo R, Tresallet C, Kuczma P, Menegaux F, Drui D, Gaujoux S, Brunaud L, Mirallie E; Eurocrine Study Group. Surgery for Primary Aldosteronism in France From 2010 to 2020 - Results from the French-Speaking Association of Endocrine Surgery (AFCE): Eurocrine Study Group. Ann Surg. 2023 Nov 1;278(5):717-724. doi: 10.1097/SLA.0000000000006026. Epub 2023 Jul 21.

  PMID: 37477017 BACKGROUND

• Mete O, Erickson LA, Juhlin CC, de Krijger RR, Sasano H, Volante M, Papotti MG. Overview of the 2022 WHO Classification of Adrenal Cortical Tumors. Endocr Pathol. 2022 Mar;33(1):155-196. doi: 10.1007/s12022-022-09710-8. Epub 2022 Mar 14.

  PMID: 35288842 BACKGROUND

• Amar L, Baguet JP, Bardet S, Chaffanjon P, Chamontin B, Douillard C, Durieux P, Girerd X, Gosse P, Hernigou A, Herpin D, Houillier P, Jeunemaitre X, Joffre F, Kraimps JL, Lefebvre H, Menegaux F, Mounier-Vehier C, Nussberger J, Pagny JY, Pechere A, Plouin PF, Reznik Y, Steichen O, Tabarin A, Zennaro MC, Zinzindohoue F, Chabre O. SFE/SFHTA/AFCE primary aldosteronism consensus: Introduction and handbook. Ann Endocrinol (Paris). 2016 Jul;77(3):179-86. doi: 10.1016/j.ando.2016.05.001. Epub 2016 Jun 15.

  PMID: 27315757 BACKGROUND

• Williams TA, Lenders JWM, Mulatero P, Burrello J, Rottenkolber M, Adolf C, Satoh F, Amar L, Quinkler M, Deinum J, Beuschlein F, Kitamoto KK, Pham U, Morimoto R, Umakoshi H, Prejbisz A, Kocjan T, Naruse M, Stowasser M, Nishikawa T, Young WF Jr, Gomez-Sanchez CE, Funder JW, Reincke M; Primary Aldosteronism Surgery Outcome (PASO) investigators. Outcomes after adrenalectomy for unilateral primary aldosteronism: an international consensus on outcome measures and analysis of remission rates in an international cohort. Lancet Diabetes Endocrinol. 2017 Sep;5(9):689-699. doi: 10.1016/S2213-8587(17)30135-3. Epub 2017 May 30.

  PMID: 28576687 BACKGROUND

MeSH Terms

Conditions

Hyperaldosteronism; Hypertension

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Nicolas GIRERD

  CIC-P

  STUDY DIRECTOR

• Claire NOMINE-CRIQUI, PH

  CVMC

  PRINCIPAL INVESTIGATOR

• Laurent BRUNAUD, PU-PH

  CVMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthias Hoeffel-Morgenthaler

CONTACT

+33770058922; matt.mhm@sfr.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PH

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 7, 2025
• Study Start: August 15, 2025
• Primary Completion: October 30, 2025
• Study Completion: March 30, 2026
• Last Updated: August 12, 2025

Record last verified: 2025-08