Overview

This trial is active, not recruiting.

Condition hyperparathyroidism
Treatments captopril, lisinopril
Sponsor Brigham and Women's Hospital
Start date October 2012
End date December 2016
Trial size 41 participants
Trial identifier NCT01691781, 2012p0001961

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Arm
(Experimental)
Lisinopril - open-label, 2.5-40mg daily
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.
lisinopril
Each subject will receive one week of lisinopril and return for repeat for blood measurements.

Primary Outcomes

Measure
Parathyroid hormone, before and after, ACE inhibitor administration
time frame: Initiation of study and after 1 week of ACE inhibitor administration

Secondary Outcomes

Measure
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
Serum calcium before and after ACE inhibitor administration
time frame: On initiation to the study and after 1 week of ACE inhibitor use

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title The Renin-Angiotensin-Aldosterone System and Parathyroid Hormone Control: The RAAS-PARC Study
Principal investigator Anand Vaidya, MD, MMSc
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Brigham and Women's Hospital.