Aldosterone Variations in Patients With Primary Hyperparathyroidism After Surgery (ALDOPARA2)

Central Hospital, Nancy, France

Status: Not yet enrolling

Conditions: Primary Hyperparathyroidism; Primary Hyperparathyroidism Due to Adenoma

Study type: Observational

Funder types: Other

Identifiers

NCT07388914

2026PI016

Details and patient eligibility

About

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 )

Full 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)

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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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Trial design

400 participants in 1 patient group

Patients with primary hyperparathyroidism

Description:

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.