Aldosterone Variations in Patients With Primary Hyperparathyroidism After Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Primary Hyperparathyroidism, Primary Hyperparathyroidism Due to Adenoma. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Aldosterone Variations in Patients With Primary Hyperparathyroidism Before Surgery and in the Year Following Surgery for Parathyroid Disease.
Overview
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 )
Detailed description
Primary hyperparathyroidism is a disorder of calcium and phosphorus metabolism linked to dysfunction of one or more parathyroid glands, without any underlying chronic kidney disease. The disease manifests itself in its classic forms as elevated blood calcium, parathyroid hormone and calcium levels. It has an impact on bone mineralisation, the presence of kidney stones, glucose metabolism (1)(2) and cardiovascular function (3)(4)(5).
A Scottish study published in 2023, based on a robust medical information system enabling prospective follow-up, showed an overall prevalence of primary hyperparathyroidism between 2007 and 2018 of 0.84%, which was much higher in women (1.18%) than in men (0.48%) (6) 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: 'Parathyroidectomy may be offered to surgical candidates with cardiovascular disease who might benefit from mitigation of potential cardiovascular sequelae other than hypertension.' There appears to be an association between hypertension and primary hyperparathyroidism (4)(5). Its mechanism is currently poorly understood and little described. Using the keywords 'hyperaldosteronism' AND 'hyperparathyroidism', we found only one case report (in Spanish) and one article, but these focused more on patients already suffering from primary hyperaldosteronism (8)(9).
The renin-angiotensin-aldosterone system is involved in regulating blood pressure.
This is why we systematically measure aldosterone and renin preoperatively and at three postoperative points following surgery for primary hyperparathyroidism.
This is a retrospective study including among 400 patients with primary hyperparathyroidism. Allt his patients underwent parathyroidectomy.
Inclusion critera : patients with primary hyperparathyroidism, age\>18 years Exclusion criteria : patients with hyperparathyroidism and renal insuffisency Pregant women, patients \< 18 years. All patients underwent blood tests including PTH, calcium, aldosterone and renin levels before surgery and 3 months, 6 months and 12 months after surgery.
The number and type of antihypertensive treatments were systematically recorded before and 3 months after surgery.
In a second step, the aldosterone levels of patients with primary hyperparathyroidism will be compared with a cohort of patients from the general population: the STNISLAS cohort, and with a cohort of patients with cardiovascular disease. This will enable to identify whether aldosterone levels in the population of patients with primary hyperparathyroidism differ from those in the general population.
The Main objective is to assess the role of phosphorus-calcium metabolism on the renin-angiotensin system in patients with primary hyperparathyroidism (PHPT)
The Secondary objectives are :
1. To describe the evolution of the renin-angiotensin system (plasma aldosterone and renin levels) before and after parathyroidectomy (at 3, 6 and 12 months) in patients with PHPT. 2. To evaluate the links between changes in phosphorus-calcium metabolism and variations in plasma aldosterone and renin levels after surgery for PHPT. 3. To evaluate changes in the number and dosage (WHO-DDD classification) of antihypertensive medications before and after surgery for PHPT. 4. To evaluate changes in blood pressure values before and after surgery for PHPT (five measurements). 5. To evaluate the links between blood pressure values before and after surgery for PHPT and changes in plasma aldosterone and renin levels. 6. To compare the renin-angiotensin system (plasma aldosterone and renin levels) in patients with PHPT versus healthy patients from the general population (STANISLAS cohort)
8\) To compare the renin-angiotensin system (plasma aldosterone and renin levels) in patients with PHPT versus patients with cardiovascular disease (REMI cohort)
Primary outcome measures
- Aldosteron variation before and after surgery [Time frame: from enrollment to 12 months after surgery]
Secondary outcome measures (11)
- Plasma Parathormon levels [Time frame: 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 [Time frame: 3 months before surgery to 12 months after surgery The measure is done at 3,6 and 12 months after surgery]
- Plasma renin levels [Time frame: 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 [Time frame: from 3 months before surgery to 3 months after]
- WHO_DDD classification [Time frame: from 3 months before surgery to 3 months after]
- Systolic and diastolic blood pressure (SBP and DBP) [Time frame: from 3 months before surgery to 3 months after]
- Preoperative glomerular filtration rate (GFR) [Time frame: 3 months before surgery.]
- Preoperative 25 OH vitD [Time frame: 3 months before surgery]
- Preoperative 24h calciuria [Time frame: 3 months before surgery]
- Kidney stones [Time frame: 3 months before surgery]
- femoral T score [Time frame: 3 months before surgery]
Eligibility criteria
Inclusion criteria
- patients with primary hyperparathyroidism candidate to surgery
- age>/=18 years
Exclusion criteria
age< 18 years patients with renal insufficiency (CKDEpi <60ml/mn) pregant women
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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Centre Hospitalier Universitaire de Nancy — Nancy
Publications
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
Identifiers
NCT: NCT07388914 · 2026PI016