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Effect of Parathyroidectomy on Cardiovascular Health

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ClinicalTrials.gov Identifier: NCT02989428
Recruitment Status : Recruiting
First Posted : December 12, 2016
Last Update Posted : May 2, 2018
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:
The aim of this study is to establish whether patients with mild primary hyperparathyroidism (PHPT) have an increased risk of cardiovascular diseases. The primary outcome is to determine whether arterial stiffness and blood pressure will decrease in patients with mild PHPT 3-month after parathyroidectomy (PTX).

Condition or disease Intervention/treatment Phase
Primary Hyperparathyroidism Procedure: Early parathyroidectomy group (EPTX-group) Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cardiovascular Health in Patients With Primary Hyperparathyroidism: Effect of Parathyroidectomy on Cardiovascular Health: A Randomized Controlled Trial
Actual Study Start Date : February 3, 2017
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : November 2018


Arm Intervention/treatment
Experimental: Early parathyroidectomy group
Parathyroidectomy (surgery), is performed as soon as possible in the experimental group after randomization.
Procedure: Early parathyroidectomy group (EPTX-group)
Participants will undergo parathyroidectomy as soon as possible

No Intervention: Late parathyroidectomy group
Parathyroidectomy (surgery), is performed three months after study inclusion.



Primary Outcome Measures :
  1. Decrease in arterial stiffness after parathyroidectomy [ Time Frame: 3 month ]
    Decrease in arterial stiffness measured by pulse wave velocity 3 month after parathyroidectomy


Secondary Outcome Measures :
  1. Decrease in systolic blood pressure after parathyroidectomy [ Time Frame: 3 month ]
    Decrease in systolic blood pressure after parathyroidectomy measured by 24-hour blood pressure monitoring

  2. Decrease in diastolic blood pressure after parathyroidectomy [ Time Frame: 3 month ]
    Decrease in diastolic blood pressure after parathyroidectomy measured by 24-hour blood pressure monitoring

  3. Decrease in central pulse pressure after parathyroidectomy [ Time Frame: 3 month ]
    Decrease in central pulse pressure after parathyroidectomy measured by pulse wave analysis

  4. Decrease in systolic blood pressure after parathyroidectomy [ Time Frame: 3 month ]
    Decrease in systolic blood pressure after parathyroidectomy measured by ambulatory blood pressure

  5. Decrease in diastolic blood pressure after parathyroidectomy [ Time Frame: 3 month ]
    Decrease in diastolic blood pressure after parathyroidectomy measured by ambulatory blood pressure


Other Outcome Measures:
  1. Quality of Life (QoL) [ Time Frame: 3 month ]
    SF-36 questionnaire version 2



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary hyperparathyroidism
  • Referred to Aarhus University Hospital with the diagnose; primary hyperparathyroidism
  • Participant is over 18 years old, able to understand and sign consent form

Exclusion Criteria:

  • Familial hypocalciuric hypercalcaemia
  • Multiple endocrine neoplasia (MEN)
  • Parathyroid cancer
  • Renal disease - GFR < 60 ml/min
  • Major heart surgery
  • Known coronary heart disease
  • NYHA III-IV
  • Known with pacemaker
  • Arrhythmia e.g. atrial fibrillations or flutter, Second- and third-degree atrioventricular block, sinoatrial depolarization of < 40 or > 160 beats per minute.
  • Ongoing treatment with beta-blockers
  • Severe manifest osteoporosis with multiple fractures
  • Severe hypercalcemia: p-ionised calcium > 1.70 mmol/L

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02989428


Contacts
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Contact: Henriette E. Svensson, MD,PhD-stud. +45 7846 7681 henrkn@rm.dk
Contact: Lars Rejnmark, M.D, PhD +45 7846 7178 larsni@rm.dk

Locations
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Denmark
Aarhus University Hospital Recruiting
Aarhus, Denmark, 8000
Contact: Henriette E. Svensson, MD,PhD-stud.    +45 7846 7681    henrkn@rm.dk   
Sponsors and Collaborators
University of Aarhus
Investigators
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Principal Investigator: Lars Rejnmark, M.D, PhD Department of Endocrinology and Internal Medicine

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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT02989428     History of Changes
Other Study ID Numbers: UAarhus170879
First Posted: December 12, 2016    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hyperparathyroidism
Hyperparathyroidism, Primary
Parathyroid Diseases
Endocrine System Diseases