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

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Mass General Brigham

Status

Completed

Conditions

Hyperparathyroidism

Treatments

Drug: Lisinopril

Study type

Interventional

Funder types

Other

Identifiers

NCT01691781
2012p0001961

Details and patient eligibility

About

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

Full 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.

Enrollment

41 patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

41 participants in 1 patient group

lisinopril
Experimental group
Description:
Lisinopril - open-label, 2.5-40mg daily
Treatment:
Drug: Lisinopril

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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