The Renin-Angiotensin-Aldosterone System and Parathyroid Hormone Control: The RAAS-PARC Study

Study Overview
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Brief Summary
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This study will evaluate whether commonly used blood pressure medications called ACE inhibitors can lower parathyroid hormone.

Detailed Description
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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.

Official Title
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The Renin-Angiotensin-Aldosterone System and Parathyroid Hormone Control: The RAAS-PARC Study

Conditions
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Hyperparathyroidism

Intervention / Treatment
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* Drug: Lisinopril


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lisinopril<br>Lisinopril - open-label, 2.5-40mg daily | Drug: Lisinopril<br>* Each subject will receive one week of lisinopril and return for repeat for blood measurements.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parathyroid Hormone Following 1 Week of ACE Inhibitor Administration | PTH values 1 week following ACE inhibitor therapy | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary Aldosterone Excretion Measurements Following 1 Week of ACE Inhibitor Therapy |  | 1 week | 
| Serum Calcium Following 1 Week of ACE Inhibitor Administration |  | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hyperparathyroidism, Renin-angiotensin-aldosterone system, ACE inhibitors