Primary Hyperparathyroidism: Non-classical Manifestations
Condition: Primary Hyperparathyroidism
MeSH terms: Hyperparathyroidism; Hyperparathyroidism, Primary
Study type: Observational

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 description: 
      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.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adults age 50 to 75 with Primary Hyperparathyroidism
      
Biospecimen description: 
      Specimens of frozen serum will be retained for possible future analyses.
    
Keywords: Primary Hyperparathyroidism