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NCT Number: NCT07388914

Aldosterone Variations in Patients With Primary Hyperparathyroidism After Surgery

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 )

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Key information

About this study

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 :

  • 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.
  • To evaluate the links between changes in phosphorus-calcium metabolism and variations in plasma aldosterone and renin levels after surgery for PHPT.
  • To evaluate changes in the number and dosage (WHO-DDD classification) of antihypertensive medications before and after surgery for PHPT.
  • To evaluate changes in blood pressure values before and after surgery for PHPT (five measurements).
  • To evaluate the links between blood pressure values before and after surgery for PHPT and changes in plasma aldosterone and renin levels.
  • To compare the renin-angiotensin system (plasma aldosterone and renin levels) in patients with PHPT versus healthy patients from the general population (STANISLAS cohort)
  • To compare the renin-angiotensin system (plasma aldosterone and renin levels) in patients with PHPT versus patients with cardiovascular disease (REMI cohort)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

Primary outcomes

  1. Aldosteron variation before and after surgery

    Time frame: from enrollment to 12 months after surgery

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

Secondary outcomes

  1. 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

    Preoperative and postoperative Plasma parathormone levels

  2. 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

    Preoperative and postoperative Plasma calcium and phosphorus levels

  3. 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

    Preoperative and postoperative Plasma renin levels

  4. type and number of antihypertensive medications

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

    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

  5. WHO_DDD classification

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

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

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

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

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

  7. Preoperative glomerular filtration rate (GFR)

    Time frame: 3 months before surgery.

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

  8. Preoperative 25 OH vitD

    Time frame: 3 months before surgery

    Plasma of 25OH vitamin D before surgery

  9. Preoperative 24h calciuria

    Time frame: 3 months before surgery

    24h calciuria 3 months before surgery

  10. Kidney stones

    Time frame: 3 months before surgery

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

  11. femoral T score

    Time frame: 3 months before surgery

    Femoral T-score on preoperative bone densitometry

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

+33383157609

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

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

Acronym: ALDOPARA2

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Feb 5, 2026
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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