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Not yet recruitingNCT07388914ALDOPARA2Updated Feb 5, 2026

Aldosterone Variations in Patients With Primary Hyperparathyroidism After Surgery

An observational study in Primary Hyperparathyroidism and Primary Hyperparathyroidism Due to Adenoma, sponsored by Central Hospital, Nancy, France. Not yet recruiting at 1 site in France. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-02-05.

Sponsored by Central Hospital, Nancy, France · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
400
Ages
18 Years to 100 Years
Sex
All
01

Study 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 )
Read the 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)

02

Conditions studied

  • Primary Hyperparathyroidism
  • Primary Hyperparathyroidism Due to Adenoma

Keywords

  • aldosteron
  • primary hyperparathyrodism
  • hypertension
03

In context

Hyperparathyroidism, Primary

104 studies on the registry are indexed under Hyperparathyroidism, Primary; 23 are open to participants now.

This study's planned enrollment of 400 is above the median of 130 across 40 observational studies indexed under Hyperparathyroidism, Primary.

Browse Hyperparathyroidism, Primary studies →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

-

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
400 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

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

    Time frame: from enrollment to 12 months after surgery

Secondary outcomes

  1. Plasma Parathormon levels

    Preoperative and postoperative Plasma parathormone levels

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

  2. Plasma Calcium and Phosphorus levels

    Preoperative and postoperative 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

  3. Plasma renin levels

    Preoperative and postoperative 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

  4. type and number of antihypertensive medications

    Preoperative and postoperative type and number of antihypertensive medications : the number, the type and the dosage of anti-hypertensive drugs is collected before and 3 months after surgery

    Time frame: from 3 months before surgery to 3 months after

  5. WHO_DDD classification

    Using the WHO\_DDD classification , a score of anti-hypertensive medication is calculated before and after surgery for each patient.

    Time frame: from 3 months before surgery to 3 months after

  6. Systolic and diastolic blood pressure (SBP and DBP)

    Preoperative and postoperative SBP and DBP value in mmHg are systematically measured 3 months before and 3 months after surgery.

    Time frame: from 3 months before surgery to 3 months after

  7. Preoperative glomerular filtration rate (GFR)

    Preoperative glomerular filtration rate (GFR) is measured before surgery. Patients with renal insufficiency are excluded.

    Time frame: 3 months before surgery.

  8. Preoperative 25 OH vitD

    Plasma of 25OH vitamin D before surgery

    Time frame: 3 months before surgery

  9. Preoperative 24h calciuria

    24h calciuria 3 months before surgery

    Time frame: 3 months before surgery

  10. Kidney stones

    Presence of kidney stones on ultrasound or abdominal CT scan prior to parathyroid surgery

    Time frame: 3 months before surgery

  11. femoral T score

    Femoral T-score on preoperative bone densitometry

    Time frame: 3 months before surgery

07

Study locations

1 site
08

References and documents

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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 31668778 ↗
  • 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. PubMed 37981555 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Feb 2026; primary completion for Sep 2026, 7 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 27, 2026
First posted
Feb 5, 2026
StartEst.
Feb 1, 2026
Primary completionEst.
Sep 2026
CompletionEst.
Feb 2027
Last update
Feb 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07388914
Responsible party
NOMINE-CRIQUI Claire (MD-Head of the endocrine surgery Unit, Central Hospital, Nancy, France) — Principal investigator
First posted
Feb 5, 2026
Start date
Feb 1, 2026 (estimated)
Primary completion
Sep 2026 (estimated)
Completion
Feb 2027 (estimated)
Last update
Feb 5, 2026

Study contacts

Claire CNC Nominé-Criqui (Head of Endocrine surgery Unit ), MD
Contact
c.nomine-criqui@chru-nancy.fr
+33383157609

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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