Aldosterone Variations in Patients With Primary Hyperparathyroidism After Surgery

NCT07388914 | Not Yet Recruiting DMC

• 1 other identifier: 2026PI016
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Primary hyperparathyroidism is a disorder of calcium and phosphorus metabolism linked to dysfunction of one or more parathyroid glands. The latest recommendations from the American Association of Endocrine Surgeons (7) consider the presence of hypertension as an argument for proposing the removal of a parathyroid adenoma in the context of primary hyperparathyroidism. The renin-angiotensin-aldosterone system is involved in regulating blood pressure. The main objective of this study is to assess aldosterone level in patients with primary hyperparathyroidism before surgery and its variation in the year following surgery for parathyroid disease. Secondary objectives are to assess aldosterone variations after surgery at 3 months

• Assess aldosterone variations after surgery at 6 months
• Assess aldosterone variations after surgery at 12 months
• Blood pressure changes before and after surgery (5 pre- and post-operative measurements)
• Assess the number of antihypertensive treatments before and after surgery
• Assess antihypertensive treatment according to the WHO-DDD classification before and after surgery Compare aldosterone levels in the 'primary hyperparathyroidism' group with a control group of patients from the general population (using the STANISLAS cohort).
• Compare aldosterone levels in the HPT group with aldosterone levels in a group of patients after myocardial infarction (cardiovascular patient group )

Conditions

Primary Hyperparathyroidism; Primary Hyperparathyroidism Due to Adenoma

Keywords

aldosteron; primary hyperparathyrodism; hypertension

Outcome Measures

Primary Outcomes (1)

• Aldosteron variation before and after surgery

  Variation of aldosteron level between the time before surgery and after surgery at 3 points : 3,6 and 12 months after surgery

  from enrollment to 12 months after surgery

Secondary Outcomes (11)

• Plasma Parathormon levels

  3 months before surgery to 12 months after surgery The measure is done at 3,6 and 12 months after surgery

• Plasma Calcium and Phosphorus levels

  3 months before surgery to 12 months after surgery The measure is done at 3,6 and 12 months after surgery

• Plasma renin levels

  3 months before surgery to 12 months after surgery The measure is done at 3,6 and 12 months after surgery

• type and number of antihypertensive medications

  from 3 months before surgery to 3 months after

• WHO_DDD classification

  from 3 months before surgery to 3 months after

Study Arms (1)

Patients with primary hyperparathyroidism

Patients with primary hyperparathyroidism who are candidates for surgery. All patients underwent biological testing for parathyroid hormone, calcium, aldosterone, renin and renal function. Their blood pressure was measured five times during the pre-operative consultation and after surgery. Their antihypertensive treatments were collected prior to surgery and after.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with primary hyperparathyroidism, without renal insufficiency , candidate to parathyroid surgery

You may qualify if:

• patients with primary hyperparathyroidism candidate to surgery
• age\>/=18 years

You may not qualify if:

• age\< 18 years patients with renal insufficiency (CKDEpi \<60ml/mn) pregant women

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

Centre Hospitalier Universitaire de Nancy

Nancy, Lorraine, 54000, France

Location

Related Publications (9)

• Martin Navarro JA, Medina Zahonero L, Procaccini FL, Barba Teba R, Rubio Menendez V, Valle Alvarez E, PoloCanovas ME, Ortega-Diaz M, Puerta Carretero M, Lucena Valverde R, Munoz Ramos P, Alcazar Arroyo R, de Sequera Ortiz P. Hyperaldosteronism and hyperparathyroidism. A disturbing friendship. Nefrologia (Engl Ed). 2024 Jul-Aug;44(4):496-502. doi: 10.1016/j.nefroe.2024.07.007. Epub 2024 Aug 5.

  PMID: 39107222 BACKGROUND

• Araujo-Castro M, Pascual-Corrales E, Fernandez-Argueso M, Bengoa-Rojano N, Garcia Cano A, Jimenez Mendiguchia L, Cuesta M. The prevalence of primary and secondary hyperparathyroidism and its cardiometabolic implications in primary aldosteronism. Minerva Endocrinol (Torino). 2023 Dec;48(4):401-410. doi: 10.23736/S2724-6507.23.03866-6. Epub 2023 May 11.

  PMID: 37166400 BACKGROUND

• Wilhelm SM, Wang TS, Ruan DT, Lee JA, Asa SL, Duh QY, Doherty GM, Herrera MF, Pasieka JL, Perrier ND, Silverberg SJ, Solorzano CC, Sturgeon C, Tublin ME, Udelsman R, Carty SE. The American Association of Endocrine Surgeons Guidelines for Definitive Management of Primary Hyperparathyroidism. JAMA Surg. 2016 Oct 1;151(10):959-968. doi: 10.1001/jamasurg.2016.2310.

  PMID: 27532368 BACKGROUND

• Soto-Pedre E, Newey PJ, Leese GP. Stable Incidence and Increasing Prevalence of Primary Hyperparathyroidism in a Population-based Study in Scotland. J Clin Endocrinol Metab. 2023 Sep 18;108(10):e1117-e1124. doi: 10.1210/clinem/dgad201.

  PMID: 37022975 BACKGROUND

• Kalla A, Krishnamoorthy P, Gopalakrishnan A, Garg J, Patel NC, Figueredo VM. Primary hyperparathyroidism predicts hypertension: Results from the National Inpatient Sample. Int J Cardiol. 2017 Jan 15;227:335-337. doi: 10.1016/j.ijcard.2016.11.080. Epub 2016 Nov 9.

  PMID: 27847154 BACKGROUND

• Han D, Trooskin S, Wang X. Prevalence of cardiovascular risk factors in male and female patients with primary hyperparathyroidism. J Endocrinol Invest. 2012 Jun;35(6):548-52. doi: 10.3275/7861. Epub 2011 Jul 12.

  PMID: 21750400 BACKGROUND

• Al-Jehani A, Al-Ahmed F, Nguyen-Thi PL, Bihain F, Nomine-Criqui C, Demarquet L, Guerci B, Ziegler O, Brunaud L. Insulin resistance is more severe in patients with primary hyperparathyroidism. Surgery. 2022 Aug;172(2):552-558. doi: 10.1016/j.surg.2022.02.012. Epub 2022 Apr 1.

  PMID: 35379519 BACKGROUND

• Koubaity O, Mandry D, Nguyen-Thi PL, Bihain F, Nomine-Criqui C, Demarquet L, Croise-Laurent V, Brunaud L. Coronary artery disease is more severe in patients with primary hyperparathyroidism. Surgery. 2020 Jan;167(1):149-154. doi: 10.1016/j.surg.2019.05.094. Epub 2019 Oct 24.

  PMID: 31668778 BACKGROUND

• Nomine-Criqui C, Bihain F, Nguyen-Thi PL, Scheyer N, Demarquet L, Klein M, Guerci B, Brunaud L. Patients with prediabetes improve insulin resistance after surgery for primary hyperparathyroidism. Surgery. 2024 Jan;175(1):180-186. doi: 10.1016/j.surg.2023.04.072. Epub 2023 Nov 18.

  PMID: 37981555 BACKGROUND

MeSH Terms

Conditions

Hyperparathyroidism, Primary; Parathyroid Neoplasms; Hypertension

Condition Hierarchy (Ancestors)

Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Claire CNC Nominé-Criqui (Head of Endocrine surgery Unit ), MD

CONTACT

+33383157609; c.nomine-criqui@chru-nancy.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD-Head of the endocrine surgery Unit

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: February 5, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: February 5, 2026

Record last verified: 2026-01

Locations

FR (1)