NCT02989428

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 2, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 12, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

February 3, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

September 30, 2019

Status Verified

April 1, 2018

Enrollment Period

1.6 years

First QC Date

December 2, 2016

Last Update Submit

September 27, 2019

Conditions

Primary Hyperparathyroidism

Outcome Measures

Primary Outcomes (1)

  • Decrease in arterial stiffness after parathyroidectomy

    Decrease in arterial stiffness measured by pulse wave velocity 3 month after parathyroidectomy

    3 month

Secondary Outcomes (5)

  • Decrease in systolic blood pressure after parathyroidectomy

    3 month

  • Decrease in diastolic blood pressure after parathyroidectomy

    3 month

  • Decrease in central pulse pressure after parathyroidectomy

    3 month

  • Decrease in systolic blood pressure after parathyroidectomy

    3 month

  • Decrease in diastolic blood pressure after parathyroidectomy

    3 month

Other Outcomes (1)

  • Quality of Life (QoL)

    3 month

Study Arms (2)

Early parathyroidectomy group

EXPERIMENTAL

Parathyroidectomy (surgery), is performed as soon as possible in the experimental group after randomization.

Procedure: Early parathyroidectomy group (EPTX-group)

Late parathyroidectomy group

NO INTERVENTION

Parathyroidectomy (surgery), is performed three months after study inclusion.

Interventions

Early parathyroidectomy group (EPTX-group)PROCEDURE

Participants will undergo parathyroidectomy as soon as possible

Early parathyroidectomy group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Related Publications (1)

  • Ejlsmark-Svensson H, Rolighed L, Rejnmark L. Effect of Parathyroidectomy on Cardiovascular Risk Factors in Primary Hyperparathyroidism: A Randomized Clinical Trial. J Clin Endocrinol Metab. 2019 Aug 1;104(8):3223-3232. doi: 10.1210/jc.2018-02456.

    PMID: 30860588DERIVED

MeSH Terms

Conditions

Hyperparathyroidism, Primary

Condition Hierarchy (Ancestors)

HyperparathyroidismParathyroid DiseasesEndocrine System Diseases

Study Officials

  • Lars Rejnmark, M.D, PhD

    Department of Endocrinology and Internal Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2016

First Posted

December 12, 2016

Study Start

February 3, 2017

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

September 30, 2019

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)