The Renin-Angiotensin-Aldosterone System and Parathyroid Hormone Control: The RAAS-PARC Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Parathyroid Hormone Following 1 Week of ACE Inhibitor Administration
研究概览
简要总结
This study will evaluate whether commonly used blood pressure medications called "ACE inhibitors" can lower parathyroid hormone.
详细描述
The RAAS-PARC study will evaluate whether angiotensin-converting enzyme inhibitors (ACEi) can lower parathyroid hormone (PTH) in normal controls and in individuals have a diagnosis of primary hyperparathyroidism.
Emerging data has implicated the renin-angiotensin-aldosterone system (RAAS) activity with increased PTH. The principal investigator, and other investigators, have previously shown that inhibiting the RAAS may lower PTH. The current study will focus on:
- Normal Physiology: Does an ACEi (which lowers angiotensin II and aldosterone) reduce PTH in normal individuals?
- Pathophysiology: Does an ACEi reduce PTH in individuals with primary hyperparathyroidism?
The results of this study may have important implications for cardiovascular and skeletal health, as both the RAAS and PTH have been implicated as mediators of these conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
盲法说明
Open Label
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects with with no medical problems (n=15) and individuals with primary hyperparathyroidism (n=30)
- •normal blood pressure or stage 1 hypertension that is either untreated, or adequately treated with a single anti-hypertensive medication.
- •Age >18 years and <80 years
- •Estimated GFR > 60ml/min
排除标准
- •Chronic Kidney Disease or eGFR<60
- •Stage 2 or Stage 3 hypertension or the use of more than 1 antihypertensive drug
- •Type 2 Diabetes Mellitus that is not controlled by diet or Metformin alone or with a Hemoglobin A1c >7.5%
- •History of liver failure
- •History of heart failure
- •The use of typical or atypical antipsychotic medications or lithium.
- •Chronic inflammatory conditions (such as inflammatory bowel disease or arthritis) that are treated with prescribed doses of NSAIDs or glucocorticoids
- •The use of prescribed doses of potassium supplements.
- •Illness requiring overnight hospitalization in the past 6 months
- •Active tobacco or recreational drug use
- •Pregnancy or current breast feeding
研究组 & 干预措施
lisinopril
Lisinopril - open-label, 2.5-40mg daily
干预措施: Lisinopril (Drug)
结局指标
主要结局
Parathyroid Hormone Following 1 Week of ACE Inhibitor Administration
时间窗: 1 week
PTH values 1 week following ACE inhibitor therapy
次要结局
- Serum Calcium Following 1 Week of ACE Inhibitor Administration(1 week)
- Urinary Aldosterone Excretion Measurements Following 1 Week of ACE Inhibitor Therapy(1 week)
研究者
Anand Vaidya
Principal Investigator
Brigham and Women's Hospital