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

Primary Purpose

Hyperparathyroidism

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lisinopril
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hyperparathyroidism focused on measuring Hyperparathyroidism, Renin-angiotensin-aldosterone system, ACE inhibitors

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

lisinopril

Arm Description

Lisinopril - open-label, 2.5-40mg daily

Outcomes

Primary Outcome Measures

Parathyroid Hormone Following 1 Week of ACE Inhibitor Administration
PTH values 1 week following ACE inhibitor therapy

Secondary Outcome Measures

Urinary Aldosterone Excretion Measurements Following 1 Week of ACE Inhibitor Therapy
Serum Calcium Following 1 Week of ACE Inhibitor Administration

Full Information

First Posted
September 20, 2012
Last Updated
August 18, 2017
Sponsor
Brigham and Women's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01691781
Brief Title
The Renin-Angiotensin-Aldosterone System and Parathyroid Hormone Control: The RAAS-PARC Study
Acronym
RAAS-PARC
Official Title
The Renin-Angiotensin-Aldosterone System and Parathyroid Hormone Control: The RAAS-PARC Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
October 2012 (Actual)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperparathyroidism
Keywords
Hyperparathyroidism, Renin-angiotensin-aldosterone system, ACE inhibitors

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
Open Label
Allocation
N/A
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
lisinopril
Arm Type
Experimental
Arm Description
Lisinopril - open-label, 2.5-40mg daily
Intervention Type
Drug
Intervention Name(s)
Lisinopril
Intervention Description
Each subject will receive one week of lisinopril and return for repeat for blood measurements.
Primary Outcome Measure Information:
Title
Parathyroid Hormone Following 1 Week of ACE Inhibitor Administration
Description
PTH values 1 week following ACE inhibitor therapy
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Urinary Aldosterone Excretion Measurements Following 1 Week of ACE Inhibitor Therapy
Time Frame
1 week
Title
Serum Calcium Following 1 Week of ACE Inhibitor Administration
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anand Vaidya, MD, MMSc
Organizational Affiliation
Brigham and Women's Hospital, Harvard Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28808443
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.
Results Reference
derived

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

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