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Completed

NCT Number: NCT01691781

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

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lisinopril

Drug

Each subject will receive one week of lisinopril and return for repeat for blood measurements.

Primary outcomes

  1. Parathyroid Hormone Following 1 Week of ACE Inhibitor Administration

    Time frame: 1 week

    PTH values 1 week following ACE inhibitor therapy

Secondary outcomes

  1. Urinary Aldosterone Excretion Measurements Following 1 Week of ACE Inhibitor Therapy

    Time frame: 1 week

  2. Serum Calcium Following 1 Week of ACE Inhibitor Administration

    Time frame: 1 week

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Acronym: RAAS-PARC

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Sep 25, 2012
Registry last updated
Sep 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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