Prospective Cohort Primary Hyperparathyroidism
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 403
- 试验地点
- 1
- 主要终点
- Occurrence of cardiovascular events, after parathyroidectomy for primary hyperparathyroidism
研究概览
简要总结
CoHPT is a prospective, monocentric, observational cohort including all patients diagnosed with primary hyperparathyroidism in Nantes University Hospital, aiming to study the outcomes associated with parathyroidectomy. Clinical and biochemical evaluation is performed at the inclusion, and 6, 12, 36 and 60 months. A biocollection is collected. The main hypotheses are that parathyroidectomy could improve cardiovascular, renal, bone, and cardiovascular outcomes along with quality of life.
详细描述
Primaty hyperparathyroidism is the third most frequent endocrine disorder, which only curative treatment is the parathyroidectomy (approximately 8000/year). However, evidences suggest that the mildest forms of PHPT could be safely monitored with simple surveillance. However, to define surgical indications is challenging because data regarding the impach of surgery on several outcomes (namely cardiovascular, bone, renal or quality of life) are controversial.
CoHPT is a prospective, monocentric, observational cohort including all consecutive patients diagnosed with sporadic primary hyperparathyroidism in Nantes University Hospital aiming to study the outcomes associated with parathyroidectomy. Patients are followed even if surgery is not performed.
A systematic clinical and biochemical evaluation is performed at the inclusion, and 6, 12, 36 and 60 months. These informations include demographic and general medical data, pre-operative imaging exams, post-operative outcomes, histopathological analysis, evaluation of the impact of primary hyperparathyroidism and its surgery on target organs (bone, kidney, cardiovascular) and quality of life. Fasting blood samples are also collected to constitute a biocollection, in order to measure biomarkers related to the bone remodeling and the cardiovascular risk.
The objectives are:
- To know the long-term consequences of the primary hyperparathyroidism treatment or observation.
- To better define the surgical indications
- To better understand the mechanisms of the cardiovascular impairment by using the biocollection
- To study the medico-economics consequences of the surgical management versus simple surveillance
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18
排除标准
- •Age < 18
- •Pregnancy / lactation
- •Adults underguardianship
- •Secondary/tertiary hyperparathyroidism
- •Multiple endocrine neoplasia
结局指标
主要结局
Occurrence of cardiovascular events, after parathyroidectomy for primary hyperparathyroidism
时间窗: Between inclusion and 12 months after surgery
Cardiovascular events include myocardial infarction, cerebrovascular and peripheral arterial events
Change in homeostasis model assessment HOMA-IR index after surgery
时间窗: Between inclusion and 12 months after surgery
HOMA-IR is calculated using fasting plasma glucose and insulin level, with the following formula: (fasting plasma insulin (mIU/L) × fasting plasma glucose (mmol/L))/22.5
Change in arterial stiffness after surgery
时间窗: Between inclusion and 12 months after surgery
Arterial stiffness is reflected by the measurement of the pulse wave velocity using the PoPmeter® instrument
Change in plasma triglycerides concentration after surgery
时间窗: Between inclusion and 12 months after surgery
Plasma triglycerides (mg/dL) will be measured using enzymatic method
Change in homeostasis model assessment HOMA-B index after surgery
时间窗: Between inclusion and 12 months after surgery
HOMA-B is calculated using fasting plasma glucose and insulin level, with the following formula: 20 × fasting plasma insulin (mIU/L)/\[fasting plasma glucose (mmol/L) - 3.5\]
Change in LDL-cholesterol concentration after surgery
时间窗: Between inclusion and 12 months after surgery
Plasma LDL-cholesterol (mg/dL) will be directly measured using enzymatic method
Change in HDL-cholesterol concentration after surgery
时间窗: Between inclusion and 12 months after surgery
Plasma HDL-cholesterol (mg/dL) will be measured using enzymatic method
次要结局
- Change in LDL-cholesterol concentration after surgery(Between inclusion and 60 months after surgery)
- Change in arterial stiffness after surgery(Between inclusion and 60 months after surgery)
- Occurrence of cardiovascular events, after parathyroidectomy for primary hyperparathyroidism(Between inclusion and 60 months after surgery)
- Change in bone-specific alkaline phosphatases(Between inclusion and 60 months after surgery)
- Change in the mental component score of the SF-36 questionnaire after surgery(Between inclusion and 60 months after surgery)
- Medico-economic impact of parathyroidectomy for primary hyperparathyroidism in comparison with simple surveillance(60 months after surgery)
- Change in bone mineral density after parathyroidectomy(Between inclusion and 60 months after surgery)
- Change in HDL-cholesterol concentration after surgery(Between inclusion and 60 months after surgery)
- Change in homeostasis model assessment HOMA-IR index after surgery(Between inclusion and 60 months after surgery)
- Change in P1NP(Between inclusion and 60 months after surgery)
- Change in plasma triglycerides concentration after surgery(Between inclusion and 60 months after surgery)
- Change in homeostasis model assessment HOMA-B index after surgery(Between inclusion and 60 months after surgery)
- Change in plasma CTX(Between inclusion and 60 months after surgery)
- Change in renal outcomes (estimated glomerular filtration rate) after parathyroidectomy(Between inclusion and 60 months after surgery)
- Change in the physical component score of the SF-36 questionnaire after surgery(Between inclusion and 60 months after surgery)