Heart and Blood Diseases

Symptoms and General Pathology

Substance Related Disorders

Wounds and Injuries

All Conditions

Cardiotoxicity

Heart Diseases

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

Radiation Injuries

Hypoglycemic Agents

All Drugs and Chemicals

Empagliflozin

Sodium-Glucose Transporter 2 Inhibitors

Empagliflozin 10 MG

Placebo

Anna Borowiec, Ph D

Barbara Nasilowska

Anna Borowiec, PhD

EMPACT (EMPAgliflozin in prevention of chemotherapy-related CardioToxicity) study is a randomized, multi-center, placebo-controlled, double-blind trial to evaluate efficacy of empagliflozin in prevention of left ventricular (LV) dysfunction in patients receiving high cumulative doses of anthracyclines. Diagnosed with cancer, 220 patients without history of heart failure and LV ejection fraction (EF) ≥ 50%, scheduled for high dose anthracyclines (doxorubicin ≥240 mg/m2 or epirubicin ≥540 mg/m2), will be included in the study. They will be randomized to a 10 mg of empagliflozin once daily or to matching placebo in a 1:1 ratio. The primary objective of the EMPACT study is to assess whether prophylactic SGLT-2 inhibitors may prevent a reduction in LVEF after high doses anthracyclines, as evaluated by serial echocardiography on each visit and cardiovascular magnetic resonance (CMR) performed at randomization and on its completion. The secondary composite endpoint includes: all-cause death, cardiovascular (CV) death, myocardial infarction and ischemic stroke. Additional secondary outcome measures include structural myocardial alterations assessed by CMR, decrease in GLS (global longitudinal strain) in echocardiography and changes in cardiac biomarkers. The study will be carried out in accordance with GCP and monitoring will be outsourced to a subcontractor - CRO. The examination will be insured and will begin as soon as the required approvals are obtained.

Malignant neoplasms are the second most common cause of death in Poland. Cancer mortality decreased by 27% over the past 25 years. Improved survival in cancer patients is related to several factors, such as prevention, early detection and the introduction of new chemotherapy regimens. However, the benefits of administration of anti-cancer drugs are partially limited by their adverse effects on the cardiovascular system, resulting in increased morbidity and mortality from complications of this treatment. The most serious toxic effect of chemotherapy is damage to the heart muscle leading to its failure, often referred to as 'cardiotoxicity'. This serious complication remains an unresolved clinical problem. The use of doxorubicin is associated with the development of congestive heart failure even in 48% of patients at the doxorubicin total dose of 700 mg/m2. The only drug approved for the prophylactic treatment of cardiac complications is dexrazoxane. However, it is only recommended for patients with advanced breast cancer receiving doxorubicin or epirubicin who have previously received a cumulative dose of 300 mg/m2 of doxorubicin or a cumulative epirubicin dose of 540 mg/m2, when further anthracycline therapy is required. Dexrazoxane is an expensive drug and may influence the effectiveness of chemotherapy. Routine prophylaxis of myocardial dysfunction is not currently recommended due to insufficient data from randomized clinical trials. So far, the prophylactic effects of such cardiological drugs as: angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs), beta-blockers, statins and ranolazine have been studied. The results of these studies are contradictory. Therefore, at present, only symptomatic patients with decreased left ventricular ejection fraction or elevated levels of cardiac biomarkers are eligible for treatment with heart failure medications. Empagliflozin is an orally administered once-daily, highly selective sodium-glucose cotransporter 2 (SGLT2) inhibitor proven to treat patients with chronic heart failure of different aetiologies, also with preserved left ventricle systolic function. This drug also has additional nephroprotective, anti-inflammatory and metabolic effects. In recent animal studies, the cardioprotective effect of empagliflozin during the use of anthracyclines was demonstrated.

EMPACT (EMPAgliflozin in prevention of chemotherapy-related CardioToxicity) study is a randomized, multi-center, placebo-controlled, double-blind trial to evaluate efficacy of empagliflozin in prevention of left ventricular (LV) dysfunction in patients receiving high cumulative doses of anthracyclines. Diagnosed with cancer, 220 patients without history of heart failure and LV ejection fraction (EF) ≥ 50%, scheduled for high dose anthracyclines (doxorubicin ≥240 mg/m2 or epirubicin ≥540 mg/m2), will be included in the study. They will be randomized to a 10 mg of empagliflozin once daily or to matching placebo in a 1:1 ratio. The primary objective of the EMPACT study is to assess whether prophylactic SGLT-2 inhibitors may prevent a reduction in LVEF after high doses anthracyclines, as evaluated by serial echocardiography on each visit and cardiovascular magnetic resonance (CMR) performed at randomization and on its completion. The secondary composite endpoint includes: all-cause death, cardiovascular (CV) death, myocardial infarction and ischemic stroke. Additional secondary outcome measures include structural myocardial alterations assessed by CMR, decrease in GLS (global longitudinal strain) in echocardiography and changes in cardiac biomarkers. This is the first study of this type in the world, we hope that the results of this project will change the standards of management of oncological patients and contribute to the improvement of their survival and quality of life.

Empagliflozin in the Prevention of Cardiotoxicity in Cancer Patients Undergoing Chemotherapy Based on Anthracyclines

Evaluation of the Effectiveness of Empagliflozin in the Prevention of Cardiotoxicity in Cancer Patients Undergoing Chemotherapy Based on Anthracyclines (EMPACT Study).

echocardiography, cardiovascular magnetic resonance

Kansas City Cardiomyopathy Questionnaire, the minimum and maximum values:0-100, higher scores mean a better outcome.

Medical Research Agency, Poland

Maria Sklodowska-Curie National Research Institute of Oncology

Principal Investigator

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Syndrome

Polycystic Ovary Syndrome

Body Weight

Weight Gain

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

Body Weight Changes

Metformin

Each participant will receive empagliflozin 10mg daily for 3 months

Each participant will receive metformin 1000mg daily for 3 months

Each participant will receive empagliflozin 10mg daily for 3 months.

Each participant will receive metformin 1000mg daily for 3 months.

MetFORMIN 500 Mg Oral Tablet

Hina Sharif, PharmD,MSPH

this is open labelled randomize control trial among women with PCOS. PCOS, an endocrine condition, affects 5%-15% of premenopausal women. PCOS is characterized by atypical menstruation, ovulation difficulties, hyperandrogenemia, insulin resistance, and other metabolic abnormalities. Metformin is now an option for PCOS. The clinical reactions to metformin are limited and varied. Novel SGLT2 inhibitors treat type 2 diabetes with weight loss, insulin resistance reduction, and cardiovascular benefits. There is little evidence on SGLT2 inhibitor effectiveness in PCOS patients.

This study for women of reproductive age only

Empagliflozin vs Metformin on Metabolic Dysfunction in Polycystic Ovary Syndrome With or Without Comorbidity or Multimorbidity

Comparing the Effects of Empagliflozin and Metformin on Metabolic Dysfunction in Polycystic Ovary Syndrome With or Without Comorbidity or Multimorbidity

Assessment of Irregular menstruation measured by menstruations lasts 2 to 7 days after three months of treatment with either empagliflozin 10mg or metformin 1000mg daily.

assessment of change in Body weight in Kg after three months treatment with either empagliflozin 10mg or metformin 1000mg daily

assessment of change in SBP in mm/Hg after three months treatment with either empagliflozin 10mg or metformin 1000mg daily

assessment of change in Blood Pressure in mg/dL after three months treatment with either empagliflozin 10mg or metformin 1000mg daily

assessment of change in Hb1c level in percentage after three months treatment with either empagliflozin 10mg or metformin 1000mg daily

assessment of fasting blood-glucose in mmol/L after three months treatment with either empagliflozin 10mg or metformin 1000mg daily

assessment of change in DBP in mm/Hg after three months treatment with either empagliflozin 10mg or metformin 1000mg daily

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Empagliflozin in the Prevention of Cardiotoxicity in Cancer Patients Undergoing Chemotherapy Based on Anthracyclines	NCT05271162	Cardiotoxicity	Empagliflozin 1... Placebo	18 Years -	Maria Sklodowska-Curie National Research Institute of Oncology
Empagliflozin vs Metformin on Metabolic Dysfunction in Polycystic Ovary Syndrome With or Without Comorbidity or Multimorbidity	NCT06140108	Polycystic Ovar... Weight Gain HbA1c	Empagliflozin 1... MetFORMIN 500 M...	15 Years - 49 Years	SINA Health Education and Welfare Trust

Spots Global Cancer Trial Database for empagliflozin 10 mg