Heart and Blood Diseases

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Substance Related Disorders

Wounds and Injuries

Heart Diseases

Breast Neoplasms

Cardiotoxicity

Breast Diseases

Skin Diseases

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

Radiation Injuries

Antineoplastic Agents

All Drugs and Chemicals

Lipid Regulating Agents

Bone Density Conservation Agents

Trastuzumab

Calcium

Atorvastatin

Calcium, Dietary

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Hypolipidemic Agents

Anticholesteremic Agents

Antimetabolites

Enzyme Inhibitors

One atorvastatin 20 mg oral capsule per day

Atorvastatin calcium, a synthetic lipid-lowering agent, is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis.

A substance that has no therapeutic effect, and will be used as a control in testing the study agent.

Placebo

Marc Goodman, PhD

The purpose of this study is to to examine the effects of atorvastatin, a type of statin, on changes to the heart among women undergoing breast cancer treatment. Atorvastatin may reduce or eliminate the harmful effects of chemotherapy treatment to the heart tissue of breast cancer patients.

This is a placebo-controlled study. It will compare the effects of atorvastatin against the effects of a placebo (an inactive substance, such as, a sugar pill) on changes to the heart before and during breast cancer treatment. Participants will be in the study for approximately a year and a half, and the study will enroll up to 60 patients. During that time, there will be six visits that may coincide with standard of care visits. Participants will also receive telephone calls from study staff during the study intervention and a follow-up phase to check-in with them.

STOP Heart Disease in Breast Cancer Survivors Trial

Statin Therapy Operates to Prevent (STOP) Heart Disease in Breast Cancer Survivors Trial

California Breast Cancer Research Program

Cedars-Sinai Medical Center

Professor and Director, Cancer Prevention & Control - Department, Cancer Institute

Regular investigator assessment, regular laboratory testing, self-reporting.

One atorvastatin 20 mg oral capsule per day

Atorvastatin: Atorvastatin calcium, a synthetic lipid-lowering agent, is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis.

Study Agent

One matching placebo daily

Placebo: A substance that has no therapeutic effect, and will be used as a control in testing the study agent.

Control

Total

Age, Categorical

Sex: Female, Male

Race (NIH/OMB)

Accrual fell well below target. Two subjects were randomized to the study and one subject completed the study. Outcome measures were not analyzed due to insufficient accrual.

As accrual fell well below target, change in global circumferential strain (GCS) measured by Cardiac MRI (CMRI) was not calculated.

Change in Global Circumferential Strain (GCS) Measured by Cardiac MRI (CMRI)

As accrual fell well below target, change in global longitudinal strain as measured by CMRI was not calculated.

Change in Global Longitudinal Strain as Measured by CMRI

As accrual fell well below target, change in peak left ventricular twist as measured by CMRI was not calculated.

Change in Peak Left Ventricular Twist as Measured by CMRI

As accrual fell well below target, change in peak left ventricular torsion as measured by CMRI was not calculated.

Change in Peak Left Ventricular Torsion as Measured by CMRI

As accrual fell well below target, change in left ventricular untwisting rate as measured by CMRI was not calculated.

Change in Left Ventricular Untwisting Rate as Measured by CMRI

As accrual fell well below target, change in left ventricular ejection fraction as measured by CMRI was not calculated.

Change in Left Ventricular Ejection Fraction as Measured by CMRI

As accrual fell well below target, change in left ventricular end diastolic volume as measured by CMRI was not calculated.

Change in Left Ventricular End Diastolic Volume as Measured by CMRI

As accrual fell well below target, change in left ventricular end systolic volume as measured by CMRI was not calculated.

Change in Left Ventricular End Systolic Volume as Measured by CMRI

As accrual fell well below target, change in cardiac output as measured by CMRI was not calculated.

Change in Cardiac Output as Measured by CMRI

As accrual fell well below target, change in left ventricular mass as measured by CMRI was not calculated.

Change in Left Ventricular Mass as Measured by CMRI

As accrual fell well below target, change in left ventricular concentricity as measured by CMRI was not calculated.

Change in Left Ventricular Concentricity as Measured by CMRI

As accrual fell well below target, change in native T1 as measured by CMRI was not calculated.

Change in Native T1 as Measured by CMRI

As accrual fell well below target, change in post contrast T1 as measured by CMRI was not calculated.

Change in Post Contrast T1 as Measured by CMRI

As accrual fell well below target, change in extracellular volume as measured by CMRI was not calculated.

Change in Extracellular Volume as Measured by CMRI

As accrual fell well below target, change in native T2 as measured by CMRI was not calculated.

Change in Native T2 as Measured by CMRI

Overall Study

Gland and Hormone Related Diseases

Neoplasm Metastasis

Hyperparathyroidism

Hyperparathyroidism, Secondary

Neoplastic Processes

Parathyroid Diseases

Endocrine System Diseases

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.

total parathyroidectomy (group 1) and those who underwent subtotal parathyroidectomy (group 2)

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.

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.

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

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
STOP Heart Disease in Breast Cancer Survivors Trial	NCT02674204	Breast Cancer Heart Disease Cardiotoxicity Myocardial Dysf...	Atorvastatin Placebo	18 Years -	Cedars-Sinai Medical Center
Changes in Cardiac Functions in Patients Treated With Parathyroidectomy for Secondary Hyperparathyroidism	NCT06187480	Secondary Hyper... Myocardial Dysf...	total parathyro...	18 Years - 80 Years	Mersin University
STOP Heart Disease in Breast Cancer Survivors Trial	NCT02674204	Breast Cancer Heart Disease Cardiotoxicity Myocardial Dysf...	Atorvastatin Placebo	18 Years -	Cedars-Sinai Medical Center
STOP Heart Disease in Breast Cancer Survivors Trial	NCT02674204	Breast Cancer Heart Disease Cardiotoxicity Myocardial Dysf...	Atorvastatin Placebo	18 Years -	Cedars-Sinai Medical Center
Changes in Cardiac Functions in Patients Treated With Parathyroidectomy for Secondary Hyperparathyroidism	NCT06187480	Secondary Hyper... Myocardial Dysf...	total parathyro...	18 Years - 80 Years	Mersin University
STOP Heart Disease in Breast Cancer Survivors Trial	NCT02674204	Breast Cancer Heart Disease Cardiotoxicity Myocardial Dysf...	Atorvastatin Placebo	18 Years -	Cedars-Sinai Medical Center

Spots Global Cancer Trial Database for myocardial dysfunction