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

This study is currently recruiting participants.
Verified November 2012 by Brigham and Women's Hospital
Sponsor:
Information provided by (Responsible Party):
Anand Vaidya, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01691781
First received: September 20, 2012
Last updated: November 30, 2012
Last verified: November 2012
History of Changes
  Purpose

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


Condition Intervention
Hyperparathyroidism
 Drug: captopril
Drug: Lisinopril

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: The Renin-Angiotensin-Aldosterone System and Parathyroid Hormone Control: The RAAS-PARC Study

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Parathyroid hormone, before and after, ACE inhibitor administration [ Time Frame: Initiation of study and after 1 week of ACE inhibitor administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Serum and urinary aldosterone measurements before and after ACE inhibitor use [ Time Frame: On initiation of the study, and after 1 week of ACE inhibitor administration ] [ Designated as safety issue: No ]
  • Serum calcium before and after ACE inhibitor administration [ Time Frame: On initiation to the study and after 1 week of ACE inhibitor use ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: October 2012
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: captopril
    At the initial visit, each subject will receive a single dose of captopril, with blood measurements before and 1-2 hours, after the dose.
    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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01691781

Contacts
Contact: Anand Vaidya, MD, MMSc 617-525-8285 avaidya1@partners.org

Locations
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Anand Vaidya, MD, MMSc     617-525-8285        
Principal Investigator: Anand Vaidya, MD, MMSc            
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

No publications provided

Responsible Party: Anand Vaidya, Principal Investigator, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01691781     History of Changes
Other Study ID Numbers: 2012p0001961
Study First Received: September 20, 2012
Last Updated: November 30, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Hyperparathyroidism
Parathyroid Diseases
Endocrine System Diseases
Captopril
Lisinopril
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Cardiotonic Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013