Clinical Trial: Primary Hyperparathyroidism: Non-classical Manifestations

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Primary Hyperparathyroidism: Non-classical Manifestations

Brief Summary: This is a research study to investigate cardiovascular health in people with mild hyperparathyroidism. Previous research has suggested that severe hyperparathyroidism may be associated with abnormalities in the heart and blood vessels. It is unclear whether mild hyperparathyroidism affects cardiovascular health. This study involves the investigation of the heart and blood vessels of people with mild hyperparathyroidism. Various non-invasive laboratory and radiological test to assess cardiovascular and bone health will be done at set intervals over the course of 2 years. It is our hypothesis that patients with primary hyperparathyroidism will have subtle abnormalities in their cardiovascular system. Using state-of-the art techniques that are sufficiently sensitive to detect these subtle abnormalities, we will define cardiovascular features of this disease that have, up to now, eluded clear definition. We expect taht the extent of these findings will be related to the severity of the underlying primary hyperparathyroidism. We further hypothesize that cardiovascular manifestations may regress with successful cure of the hyperparathyroid state.

Detailed Summary:

This study involves a total of 4 visits over a 2-year period. A variety of tests to evaluate your cardiovascular and bone health are performed. The details and timing of the tests are explained below.

VISIT #1 During the first visit, a research doctor or assistant explains the procedures in detail and answers questions. Blood is drawn (about 1-2 tablespoons) to confirm the diagnosis of hyperparathyroidism and get baseline blood values.

VISIT #2-4 During the following visits, a variety of procedures are performed to evaluate cardiovascular and bone health. The details of the procedures and when they will be performed are outlined below.

1. Blood tests are performed at each visit. Approximately 1-2 tablespoons of blood will be drawn at each visit.
2. A 24-hour urine collection is done 3 times during the 2 year study.
3. Bone mineral density testing (known as DXA) is performed at baseline, 12 and 24 months after enrollment.
4. Carotid Ultrasound: At the baseline visit, 12 and 24 months after enrollment, carotid ultrasound is performed.
5. Echocardiogram: At the baseline visit, 12 and 24 months after enrollment, an echocardiogram is performed.
6. Endothelial Function: At baseline, 6 and 12 months after enrollment, flow mediated dilation of the brachial artery is performed.

Sponsor: Columbia University

Current Primary Outcome: Structural evidence of increased vascular stiffness or cardiovascular calcification in patients with mild asymptomatic PHPT [ Time Frame: 2 years ]

Original Primary Outcome:

Current Secondary Outcome:

• Evidence of abnormal cardiovascular function in patients with mild asymptomatic PHPT [ Time Frame: 2 years ]
  To determine whether or not there is evidence of abnormal cardiovascular function in patients with mild asymptomatic PHPT, and to determine the reversibility of these manifestations after successful parathyroidectomy
• Evidence of abnormal cardiovascular structure or function in patients with asymptomatic PHPT who meet NIH Guidelines for Surgery [ Time Frame: 2 years ]
  To determine whether or not there is evidence of abnormal cardiovascular structure or function in patients with asymptomatic PHPT who meet NIH Guidelines for Surgery, and to determine the reversibility of these manifestations after successful parathyroidectomy

Original Secondary Outcome:

Information By: Columbia University

Dates:
Date Received: February 6, 2007
Date Started: October 2005
Date Completion:
Last Updated: March 6, 2015
Last Verified: March 2015