Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06419270
Status:
RECRUITING
Last Update Posted:
2024-05-23
First Post:
2024-05-07
Brief Title:
Cardiovascular Renal and Skeletal Complications in Patients With Post-Surgical Hypoparathyroidism
Sponsor:
University of Aarhus
Organization:
University of Aarhus
Study Overview
Official Title:
Cardiovascular Renal and Skeletal Complications in Patients With Post-Surgical Hypoparathyroidism
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAREHYPO
Brief Summary:
The aim of this observational study is to learn about long term effects to post surgical hypoparathyroidism The main questions are
1 Patients with hypoparathyroidism do not have an increased arterial stiffness compared to healthy controls
2 Patients with hypoparathyroidism do not have an increased coronary artery plaque burden assessed by cardiac CT compared to healthy controls
3 Patients with hypoparathyroidism do not have an increased prevalence of vertebral fractures compared to healthy controls
Results will be compared with gender and age matched controls from the general population
Participants will have a CT scan DXA scan tonometry blood samples and questionaries performed and collect a 24-hour urine sample
1 Patients with hypoparathyroidism do not have an increased arterial stiffness compared to healthy controls
2 Patients with hypoparathyroidism do not have an increased coronary artery plaque burden assessed by cardiac CT compared to healthy controls
3 Patients with hypoparathyroidism do not have an increased prevalence of vertebral fractures compared to healthy controls
Results will be compared with gender and age matched controls from the general population
Participants will have a CT scan DXA scan tonometry blood samples and questionaries performed and collect a 24-hour urine sample
Detailed Description:
Hypoparathyroidism is a rare endocrine disorder characterized by hypocalcemia with low or undetectable levels of parathyroid hormone The most common cause of hypoparathyroidism is following neck surgery whereas approximately 25 of hypoparathyroidism patients are suffering from non-surgical hypoparathyroidism due to eg genetic or autoimmune causes According to updated international guidelines the condition is considered chronic if treatment with calcium and activated vitamin D is still needed a year after surgery
A large retrospective cohort study of patients with chronic hypoparathyroidism shows that patients with chronic hypoparathyroidism have a significantly higher risk of cardiovascular disease compared to patients without hypoparathyroidism Additionally it is well known that patients with hypoparathyroidism are at increased risk of renal and extra-skeleton calcifications although cardiovascular calcifications are only sparsely investigated Furthermore both higher arterial stiffness assessed by pulse wave velocity and an increased heart rate have previously been shown in patients with non-surgical hypoparathyroidism It is largely unknown whether this also applies to patients with post-surgical hypoparathyroidism
The overall aim of the project is to investigate cardiovascular renal and skeletal indices in patients diagnosed with Post Surgical hypoparathyroidism and test the following null-hypotheses
1 H0 Patients with post-surgical hypoparathyroidism do not have an increased arterial stiffness compared to healthy controls
2 H0 Patients with post-surgical hypoparathyroidism do not have an increased coronary artery plaque burden assessed by cardiac CT compared to healthy controls
3 H0 Patients with post-surgical hypoparathyroidism do not have an increased prevalence of vertebral fractures compared to healthy controls
Patients and controls who accept participation will undergo a detailed examination in terms of Medical history physical examination questionnaires blood and 24-hour urine samples DXA scan HRpQCT tonometry 12-lead electrocardiogram 24-hour blood pressure and a CT scan
Data are analyzed according to their distribution using parametric or non-parametric statistics To address the hypotheses statistical power calculations have been performed
50 patients with post-surgical hypoparathyroidism will be matched on sex and age 2 years with 50 randomly selected otherwise healthy controls from the general population
A large retrospective cohort study of patients with chronic hypoparathyroidism shows that patients with chronic hypoparathyroidism have a significantly higher risk of cardiovascular disease compared to patients without hypoparathyroidism Additionally it is well known that patients with hypoparathyroidism are at increased risk of renal and extra-skeleton calcifications although cardiovascular calcifications are only sparsely investigated Furthermore both higher arterial stiffness assessed by pulse wave velocity and an increased heart rate have previously been shown in patients with non-surgical hypoparathyroidism It is largely unknown whether this also applies to patients with post-surgical hypoparathyroidism
The overall aim of the project is to investigate cardiovascular renal and skeletal indices in patients diagnosed with Post Surgical hypoparathyroidism and test the following null-hypotheses
1 H0 Patients with post-surgical hypoparathyroidism do not have an increased arterial stiffness compared to healthy controls
2 H0 Patients with post-surgical hypoparathyroidism do not have an increased coronary artery plaque burden assessed by cardiac CT compared to healthy controls
3 H0 Patients with post-surgical hypoparathyroidism do not have an increased prevalence of vertebral fractures compared to healthy controls
Patients and controls who accept participation will undergo a detailed examination in terms of Medical history physical examination questionnaires blood and 24-hour urine samples DXA scan HRpQCT tonometry 12-lead electrocardiogram 24-hour blood pressure and a CT scan
Data are analyzed according to their distribution using parametric or non-parametric statistics To address the hypotheses statistical power calculations have been performed
50 patients with post-surgical hypoparathyroidism will be matched on sex and age 2 years with 50 randomly selected otherwise healthy controls from the general population
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None