Clinical trial NCT01691781: The Renin-Angiotensin-Aldosterone System and Parathyroid Hormone Control: The RAAS-PARC Study
Official title: The Renin-Angiotensin-Aldosterone System and Parathyroid Hormone Control: The RAAS-PARC Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperparathyroidism
Keywords: Hyperparathyroidism
Renin-angiotensin-aldosterone system
ACE inhibitors
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2012-09-25
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study will evaluate whether commonly used blood pressure medications called "ACE inhibitors" can lower parathyroid hormone.

Detailed description: 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:

1. Normal Physiology: Does an ACEi (which lowers angiotensin II and aldosterone) reduce PTH in normal individuals?
2. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Parathyroid Hormone Following 1 Week of ACE Inhibitor Administration
timeFrame: 1 week
Secondary outcomes:
measure: Urinary Aldosterone Excretion Measurements Following 1 Week of ACE Inhibitor Therapy
timeFrame: 1 week
measure: Serum Calcium Following 1 Week of ACE Inhibitor Administration
timeFrame: 1 week
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital, Harvard Medical School
name: Anand Vaidya, MD, MMSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zaheer S, Brown JM, Connors M, Williams JS, Adler GK, Vaidya A. Angiotensin-Converting Enzyme Inhibition and Parathyroid Hormone Secretion. Int J Endocrinol. 2017;2017:4138783. doi: 10.1155/2017/4138783. Epub 2017 Jul 20.