Aldosterone Variations in Patients With Primary Hyperparathyroidism Before Surgery and in the Year Following Surgery for Parathyroid Disease.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Aldosteron variation before and after surgery
研究概览
简要总结
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
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Assess aldosterone variations after surgery at 6 months
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Assess aldosterone variations after surgery at 12 months
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Blood pressure changes before and after surgery (5 pre- and post-operative measurements)
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Assess the number of antihypertensive treatments before and after surgery
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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).
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Compare aldosterone levels in the HPT group with aldosterone levels in a group of patients after myocardial infarction (cardiovascular patient group )
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with primary hyperparathyroidism candidate to surgery
- •age>/=18 years
排除标准
- •age< 18 years patients with renal insufficiency (CKDEpi <60ml/mn) pregant women
研究组 & 干预措施
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.
结局指标
主要结局
Aldosteron variation before and after surgery
时间窗: 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
次要结局
- Plasma Parathormon levels(3 months before surgery to 12 months after surgery The measure is done at 3,6 and 12 months after surgery)
- Plasma Calcium and Phosphorus levels(3 months before surgery to 12 months after surgery The measure is done at 3,6 and 12 months after surgery)
- Plasma renin levels(3 months before surgery to 12 months after surgery The measure is done at 3,6 and 12 months after surgery)
- type and number of antihypertensive medications(from 3 months before surgery to 3 months after)
- WHO_DDD classification(from 3 months before surgery to 3 months after)
- Systolic and diastolic blood pressure (SBP and DBP)(from 3 months before surgery to 3 months after)
- Preoperative glomerular filtration rate (GFR)(3 months before surgery.)
- Preoperative 25 OH vitD(3 months before surgery)
- Preoperative 24h calciuria(3 months before surgery)
- Kidney stones(3 months before surgery)
- femoral T score(3 months before surgery)
研究者
NOMINE-CRIQUI Claire
MD-Head of the endocrine surgery Unit
Central Hospital, Nancy, France