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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01691781
First Posted: September 25, 2012
Last Update Posted: September 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Anand Vaidya, Brigham and Women's Hospital
  Purpose
This study will evaluate whether commonly used blood pressure medications called "ACE inhibitors" can lower parathyroid hormone.

Condition Intervention
Hyperparathyroidism Drug: Lisinopril

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description:
Open Label
Primary Purpose: Other
Official Title: The Renin-Angiotensin-Aldosterone System and Parathyroid Hormone Control: The RAAS-PARC Study

Resource links provided by NLM:


Further study details as provided by Anand Vaidya, Brigham and Women's Hospital:

Primary Outcome Measures:
  • Parathyroid Hormone Following 1 Week of ACE Inhibitor Administration [ Time Frame: 1 week ]
    PTH values 1 week following ACE inhibitor therapy


Secondary Outcome Measures:
  • Urinary Aldosterone Excretion Measurements Following 1 Week of ACE Inhibitor Therapy [ Time Frame: 1 week ]
  • Serum Calcium Following 1 Week of ACE Inhibitor Administration [ Time Frame: 1 week ]

Enrollment: 41
Actual Study Start Date: October 2012
Study Completion Date: December 2016
Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: lisinopril
Lisinopril - open-label, 2.5-40mg daily
Drug: Lisinopril
Each subject will receive one week of lisinopril and return for repeat for blood measurements.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01691781


Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Anand Vaidya, MD, MMSc Brigham and Women's Hospital, Harvard Medical School
  More Information

Responsible Party: Anand Vaidya, Principal Investigator, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01691781     History of Changes
Other Study ID Numbers: 2012p0001961
First Submitted: September 20, 2012
First Posted: September 25, 2012
Results First Submitted: June 19, 2017
Results First Posted: August 10, 2017
Last Update Posted: September 21, 2017
Last Verified: August 2017

Keywords provided by Anand Vaidya, Brigham and Women's Hospital:
Hyperparathyroidism
Renin-angiotensin-aldosterone system
ACE inhibitors

Additional relevant MeSH terms:
Hyperparathyroidism
Parathyroid Diseases
Endocrine System Diseases
Hormones
Lisinopril
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Cardiotonic Agents
Protective Agents