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Primary HyperparathyroidismALDOPARA2NCT07388914

Aldosterone Variations in Patients With Primary Hyperparathyroidism After Surgery

An observational study of Primary Hyperparathyroidism and Primary Hyperparathyroidism Due to Adenoma, run by Central Hospital, Nancy, France at 1 site in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 100 years
How many people
400 participants
Where
1 siteFrance
Study dates
1 Feb 2026to Feb 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

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

+33383157609

c.nomine-criqui@chru-nancy.fr

France1 site
  • Centre Hospitalier Universitaire de Nancy

    Nancy, Lorraine, 54000

Other trials in France

About this study

Official title: Aldosterone Variations in Patients With Primary Hyperparathyroidism Before Surgery and in the Year Following Surgery for Parathyroid Disease.

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.

Read more

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)
  7. To compare the renin-angiotensin system (plasma aldosterone and renin levels) in patients with PHPT versus patients with cardiovascular disease (REMI cohort)
Keywords
aldosteron, primary hyperparathyrodism, hypertension
Medical subject headings
Hyperparathyroidism, Primary, Parathyroid Neoplasms, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07388914
Study groupRoleWhat they receive
Patients with primary hyperparathyroidismPatients 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: from enrollment to 12 months after surgery

Secondary outcomes (11)
  1. Plasma Parathormon levels

    Preoperative and postoperative Plasma parathormone levels

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 3 months before surgery.

  8. Preoperative 25 OH vitD

    Plasma of 25OH vitamin D before surgery

    Measured: 3 months before surgery

  9. Preoperative 24h calciuria

    24h calciuria 3 months before surgery

    Measured: 3 months before surgery

  10. Kidney stones

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

    Measured: 3 months before surgery

  11. femoral T score

    Femoral T-score on preoperative bone densitometry

    Measured: 3 months before surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2026
  2. Study start1 Feb 2026 (estimated)
  3. Primary completionSep 2026 (estimated)
  4. Study completionFeb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07388914
Sponsor's protocol ID
2026PI016
Acronym
ALDOPARA2
Status last verified
Jan 2026
First submitted
27 Jan 2026
Last updated
5 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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

Questions about this trial

What is this clinical trial studying?

An observational study of Primary Hyperparathyroidism and Primary Hyperparathyroidism Due to Adenoma, run by Central Hospital, Nancy, France at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Claire CNC Nominé-Criqui (Head of Endocrine surgery Unit ), MD (+33383157609, c.nomine-criqui@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Aldosteron variation before and after surgery (time frame: from enrollment to 12 months after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07388914, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026; AzTrials last refreshed its copy on 1 Nov 2026.

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