An observational study in Primary Hyperparathyroidism, sponsored by Columbia University. Completed at 1 site in United States. Open to participants aged 50 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-03-09.
Sponsored by Columbia University · Observational
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.
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.
305 studies on the registry are indexed under Hyperparathyroidism; 23 are open to participants now.
This study's enrollment of 58 is below the median of 100 across 88 observational studies indexed under Hyperparathyroidism.
Browse Hyperparathyroidism studies →Columbia University is the lead sponsor of 1,103 studies on the registry; 193 are open to participants now.
Of its 172 completed or terminated interventional studies of FDA-regulated products, 142 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adults age 50 to 75 with Primary Hyperparathyroidism
-Primary Hyperparathyroidism
Exclusion Criteria:
Structural evidence of increased vascular stiffness or cardiovascular calcification in patients with mild asymptomatic PHPT
To determine whether or not there is structural evidence of increased vascular stiffness or cardiovascular calcification in patients with mild asymptomatic PHPT as compared to matched healthy controls, and to determine the reversibility of these manifestations after successful parathyroidectomy
Time frame: 2 years
Evidence of abnormal cardiovascular function in patients with mild asymptomatic PHPT
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
Time frame: 2 years
Evidence of abnormal cardiovascular structure or function in patients with asymptomatic PHPT who meet NIH Guidelines for Surgery
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
Time frame: 2 years
To determine the association between the severity of PHPT and the presence of altered cardiovascular structure and function
To determine the association between the severity of PHPT and the presence of altered cardiovascular structure and function as assessed in outcomes 1 to 3
Time frame: 2 years
This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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Columbia University