Centre Hospitalier Universitaire de Nancy
Nancy, Lorraine, 54000, France
NCT Number: NCT07388914
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 )
Trial opening soon.
Get Notified18 year–100 year
All sexes
Observational
Nancy, Lorraine, 54000, France
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 :
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
age< 18 years patients with renal insufficiency (CKDEpi <60ml/mn) pregant women
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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
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
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
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
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
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.
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.
Time frame: 3 months before surgery.
Preoperative glomerular filtration rate (GFR) is measured before surgery. Patients with renal insufficiency are excluded.
Time frame: 3 months before surgery
Plasma of 25OH vitamin D before surgery
Time frame: 3 months before surgery
24h calciuria 3 months before surgery
Time frame: 3 months before surgery
Presence of kidney stones on ultrasound or abdominal CT scan prior to parathyroid surgery
Time frame: 3 months before surgery
Femoral T-score on preoperative bone densitometry
Contact information is provided by the study sponsor or research team.
Claire CNC Nominé-Criqui (Head of Endocrine surgery Unit ), MD
CONTACT
Central Hospital, Nancy, France
Other
Aldosterone Variations in Patients With Primary Hyperparathyroidism Before Surgery and in the Year Following Surgery for Parathyroid Disease.
Acronym: ALDOPARA2
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