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Secondary HyperparathyroidismNCT06187480

Changes in Cardiac Functions in Patients Treated With Parathyroidectomy for Secondary Hyperparathyroidism

An observational study of Secondary Hyperparathyroidism and Myocardial Dysfunction, run by Mersin University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aims to investigate the changes in cardiac functions, especially myocardial performance index (MPI), in patients who underwent parathyroidectomy for secondary hyperparathyroidism. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
total parathyroidectomy (group 1) and those who underwent subtotal parathyroidectomy (group 2)
Type of treatment
Surgery or procedure
How many people
37 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jan 2021to 1 Jan 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Adult, Older adult

Study population: The patients who developed secondary hyperparathyroidism after chronic renal failure and underwent subtotal/total parathyroidectomy in our hospital between June 2010 and September 2021 were analyzed with a single-center Nested case-control study design.

Who may be able to join

  • Patients with a diagnosis of chronic renal failure, secondary hyperthyroidism after chronic renal failure, preoperative and postoperative laboratory tests, parathyroidectomy operation, and preoperative and postoperative 6-month transthoracic echocardiography (ECHO) were included in the study.

Who cannot join

  • Advanced-stage lung disease, atrial fibrillation, atrial and supraventricular tachycardia, extra ventricular beats, intraventricular conduction disorders, ventricular pacing, moderate to severe valve pathology, history of bypass surgery, poor image quality in transthoracic echocardiography as cardiac comorbidities Patients with disease and missing data were excluded from the study.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Mersin University Faculty of Medicine

    Mersin, 33400

Other trials in Turkey (Türkiye)

About this study

This study aims to investigate the changes in cardiac functions, especially myocardial performance index (MPI), in patients who underwent parathyroidectomy for secondary hyperparathyroidism.

Participants who underwent parathyroidectomy for secondary hyperparathyroidism between June 2010 and September 2021 were analyzed retrospectively. The participants were divided into two groups: those who underwent total parathyroidectomy (group 1) and those who underwent subtotal parathyroidectomy (group 2). The groups were compared according to the echocardiogram findings performed in the preoperative period and the postoperative sixth month. In addition, cardiac structure, systolic and diastolic function, especially myocardial performance index, were evaluated by echocardiography and Doppler imaging.

Read the detailed description

Patient selection

The participants who developed secondary hyperparathyroidism after chronic renal failure and underwent subtotal/total parathyroidectomy in our hospital between June 2010 and September 2021 were analyzed with a single-center Nested case-control study design.

Patients with a diagnosis of chronic renal failure, secondary hyperthyroidism after chronic renal failure, preoperative and postoperative laboratory tests, parathyroidectomy operation, and preoperative and postoperative 6-month transthoracic echocardiography (ECHO) were included in the study.

Advanced-stage lung disease, atrial fibrillation, atrial and supraventricular tachycardia, extra ventricular beats, intraventricular conduction disorders, ventricular pacing, moderate to severe valve pathology, history of bypass surgery, poor image quality in transthoracic echocardiography as cardiac comorbidities Patients with disease and missing data were excluded from the study.

Data collection

Demographic data (age, gender), surgery (total/subtotal parathyroidectomy) preoperative and postoperative laboratory analyses, and ECHO reports of the patients were recorded. In laboratory values, glucose, hemoglobin, albumin, blood urea nitrogen (BUN), creatinine, calcium, phosphorus, and parathormone values were recorded. In ECHO reports, left ventricular end-diastolic diameter (cm), left ventricular end-systolic diameter (cm), left ventricular end-diastolic septum thickness (cm), left ventricular end-diastolic posterior wall thickness (cm), ejection fraction (%), fractional shortening, end-diastolic volume, end-systolic volume, ejection volume, isovolumetric relaxation time (IVRT), isovolumetric contraction time (IVCT), ejection time (ET) and myocardial performance index (MPI) data were recorded.

Surgical Technique

Patients resistant to calcimimetics and vitamin D analogs, patients with symptoms such as bone and joint pain, persistent itching, and muscle aches, and patients whose symptoms affect their quality of life are among the indications for surgery. In addition, parathyroidectomy was performed on patients with uncontrolled hyperphosphatemia, anemia hyporesponsive to erythropoietin therapy, hypercalcemia, and vascular and tissue calcifications, considered complications of SHPT.

Subtotal or total parathyroidectomy is performed in the SHPT. Total parathyroidectomy was performed without autotransplantation to prevent recurrent resistant SHPT in patients with long life expectancy and little or no possibility of kidney transplantation. In the preoperative period, routine ultrasound and 99mTc-sestamibi scintigraphy were performed on the patients. During neck exploration, tissues considered the parathyroid gland were examined as a frozen section. As a result of the frozen section, it was confirmed how many glands were removed. After parathyroidectomy was completed, intraoperative parathormone testing was performed in all patients, and it was observed that parathormone levels decreased. In the subtotal parathyroidectomy procedure, four parathyroid glands are explored. Usually, half of the parathyroid gland, closest to normal in appearance and size, is left in place with its vascular network. Other glands are excised. In the total parathyroidectomy procedure, four parathyroid glands are explored and excised. Then, a part of the parathyroid gland closest to normal in appearance and size is auto-transplanted into the sternoclaidomastoid muscle or the forearm. The transplantation area is marked with a metal clip.

Echocardiography (ECHO)

All patients were evaluated with two-dimensional, pulse-wave Doppler and tissue Doppler echocardiography. Philips HD11 XE device was used to detect echocardiographic data. Parasternal long axis view with M-Mode echocardiography method left ventricular interventricular septum thickness, left ventricular posterior wall thickness, left ventricular end-diastolic diameter, left ventricular end-systolic diameter, left ventricular end-diastolic volume, left ventricular end-systolic volume, left ventricular end-systolic volume, and fractional shortening data were determined. In addition, left ventricular stroke volume was determined by subtracting the left ventricular end-systolic volume from the left ventricular end-diastolic volume.

Myocardial performance index calculation technique

The myocardial performance index (MPI) is a numerical value obtained using cardiac time intervals. This numerical value was obtained by dividing the sum of isovolumetric contraction time (ICT) and isovolumetric relaxation time (IRT) by ejection time (ET). MPI can be detected using conventional Pulse-wave Doppler or tissue Doppler echocardiography. The mean average left ventricular (LV) MPI value is 0.39 ± 0.05. In adults, LV MPI values less than 0.40 are considered normal. Higher index values are associated with cardiac dysfunction.

Our study obtained cardiac time intervals using Pulsed wave Doppler echocardiography techniques. MPI, Pulsed wave Doppler echocardiography from the apical four-chamber images, by placing the sample volume at the endpoints of the mitral valves, the time interval between the end and the beginning of the mitral flow (a), switching to the apical five-chamber images and placing the sample volume in the left ventricular outflow tract just below the aortic valves to determine the left ventricular ET (b) was done. The left ventricular isovolumetric (ICT+IRT) sum was calculated by subtracting left ventricular ET from the time interval between the end and beginning of mitral flow (a-b). Thus, MPI [(a-b)/b] was obtained.

Statistical analysis

Mean and standard deviation were used for the statistics of continuous data. Median, minimum, and maximum values were used for continuous or ordinal data that did not show normal distribution. Frequency (n) and percentage (%) values were used to define categorical variables. Fisher's exact test was used to compare the means of two independent groups. The chi-square test was used to evaluate the relationship between categorical variables. Paired t-test was used to compare the patient's preoperative and postoperative numerical data. The statistical significance level of the data was taken as p<0.05. The statistical program www.e-picos.com was used to evaluate the data.

Being tested
total parathyroidectomy (group 1) and those who underwent subtotal parathyroidectomy (group 2)
Keywords
Secondary hyperparathyroidism, myocardial performance index
Medical subject headings
Hyperparathyroidism, Secondary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • total parathyroidectomy (group 1) and those who underwent subtotal parathyroidectomy (group 2)Procedure or surgery

    The groups were compared according to the echocardiogram findings performed in the preoperative period and the postoperative sixth month. In addition, cardiac structure, systolic and diastolic function, especially myocardial performance index, were evaluated by echocardiography and Doppler imaging.

Study groups in NCT06187480
Study groupRoleWhat they receive
group 1underwent total parathyroidectomy
Receives: Procedure: total parathyroidectomy (group 1) and those who underwent subtotal parathyroidectomy (group 2)
group 2underwent subtotal parathyroidectomy
Receives: Procedure: total parathyroidectomy (group 1) and those who underwent subtotal parathyroidectomy (group 2)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Comparison of myocardial performance indexes between groups

    Evaluation of patients' myocardial performance indexes between groups using echocardiography and Doppler imaging in the preoperative period and at the 6th postoperative month.

    Measured: preoperatively and postoperative 6th month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jan 2024
  2. Study start1 Jan 2021
  3. Primary completion31 Dec 2022
  4. Study completion1 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06187480
Sponsor's protocol ID
E-78017789-050.01.04-1638902
Status last verified
Dec 2023
First submitted
2 Dec 2023
Last updated
3 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Benli S, Yesil E, Tazeoglu D, Ozcan C, Ozcan IT, Dag A. Changes in cardiac functions in patients treated with parathyroidectomy for secondary hyperparathyroidism. Updates Surg. 2024 Aug;76(4):1443-1452. doi: 10.1007/s13304-024-01812-8. Epub 2024 Mar 26.

    PubMed 38530609

Questions about this trial

What is this clinical trial studying?

An observational study of Secondary Hyperparathyroidism and Myocardial Dysfunction, run by Mersin University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison of myocardial performance indexes between groups (time frame: preoperatively and postoperative 6th month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06187480, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2024.

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