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

Hyperparathyroidism Clinical Trial

— RAAS-PARC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01691781
• Other study ID #: 2012p0001961
• Status: Completed
• Phase: N/A
• First received: September 20, 2012
• Last updated: August 18, 2017
• Start date: October 2012
• Est. completion date: December 2016

Study information

• Verified date: August 2017
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: December 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperparathyroidism

Intervention

Drug:
• Lisinopril
Each subject will receive one week of lisinopril and return for repeat for blood measurements.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parathyroid Hormone Following 1 Week of ACE Inhibitor Administration	PTH values 1 week following ACE inhibitor therapy	1 week
Secondary	Urinary Aldosterone Excretion Measurements Following 1 Week of ACE Inhibitor Therapy		1 week
Secondary	Serum Calcium Following 1 Week of ACE Inhibitor Administration		1 week