Evaluation of Dapagliflozin Propanediol on Echocardiographic Cardiac Structure and Function in Chronic Kidney Disease: A 6-Month Randomized Double-Blind Study

The primary objective of this study is to evaluate the effect of **dapagliflozin** on echocardiographic measures of cardiac structure and function in patients with chronic kidney disease (CKD). This includes assessing changes in cardiac structure, as well as systolic and diastolic cardiac function, across all stages of CKD of varying etiologies. Understanding these effects is clinically relevant as it may provide insights into the potential cardiovascular benefits of dapagliflozin in a population at high risk for cardiac complications. The study aims to establish a proof of concept regarding the impact of dapagliflozin on cardiac health in CKD patients.

The clinical trial involves participants diagnosed with **chronic kidney disease** (CKD) across all stages and of various etiologies. The study population includes both male and female subjects, aged 18 years and older. Participants are required to have a stable treatment regimen, particularly those with proteinuria who are on ACE inhibitors or ARBs, unless medically contraindicated. The trial also includes individuals with type 2 diabetes who have maintained stable antihyperglycemic treatment for over 30 days prior to screening. Female participants must adhere to specific contraceptive guidelines if of childbearing potential. The trial does not involve a vulnerable population. The sponsor has not provided information regarding the total number of participants. Participants were selected based on their ability to understand and read Danish, among other criteria. Lifestyle factors such as diet and physical activity are not specified in the available data.

The clinical trial is a **randomized, double-blind, controlled** study designed to evaluate the effect of **dapagliflozin** on echocardiographic measures of cardiac structure and function in patients with **chronic kidney disease** (CKD). The trial is set to last for a duration of six months, with the primary endpoint being the change in left ventricular (LV) mass index assessed by echocardiography at the end of the study period. Secondary endpoints include changes in LV ejection fraction, global longitudinal strain, LV end-diastolic and end-systolic volumes, left atrial volume index, creatinine/eGFR, UACR, hemoglobin, proBNP, and troponin levels, all measured at six months.

Participants will be involved in the study for approximately six months, with the possibility of early termination if they do not adhere to the study protocol or if they experience adverse events that necessitate withdrawal. The study will commence with an inclusion (screening) visit to confirm eligibility based on criteria such as age, CKD status, and stable treatment regimens. Following randomization, participants will receive either dapagliflozin or a placebo, which is identical in appearance and contains FDA/E172 Red Iron Oxide, Titanium dioxide, and Hydromellose.

Study visits will be scheduled at regular intervals to monitor the participants' health status and collect data on the specified endpoints. These visits will include assessments of cardiac function through echocardiography and laboratory tests to measure relevant biomarkers. The end-of-study visit will occur at the six-month mark, where final assessments will be conducted to evaluate the primary and secondary endpoints. The trial is expected to conclude by January 2028, with recruitment having started in June 2022.

The clinical trial involves the administration of **Dapagliflozin Propanediol**, a chemical compound with the active substance name **Dapagliflozin Propanediol**. The pharmaceutical form of this medication is identified as PHF00082MIG. The medication is administered orally. The trial aims to evaluate the effects of Dapagliflozin on cardiac structural changes and cardiac function in patients with chronic kidney disease. The dosing schedule and frequency of administration are not specified in the provided data. Participant compliance will be monitored throughout the study to ensure adherence to the dosing regimen.

The study also includes a **placebo** that is identical in appearance to the experimental medication. The placebo contains the following inactive ingredients: FDA/E172 Red Iron Oxide, Titanium dioxide, and Hydromellose. The placebo is used to maintain the double-blind nature of the study, ensuring that neither the participants nor the investigators know which treatment is being administered. The route of administration for the placebo is consistent with that of the experimental medication, which is oral. The placebo serves as a comparator treatment to assess the efficacy and safety of Dapagliflozin in the study population.

Efficacy in this clinical trial will be assessed through a series of primary and secondary endpoints, focusing on the impact of **dapagliflozin** on cardiac structure and function in patients with chronic kidney disease (CKD). The primary endpoint is the change in left ventricular (LV) mass index, which will be evaluated using echocardiography at the 6-month mark. Secondary endpoints include changes in LV ejection fraction, global longitudinal strain, LV end-diastolic volume, LV end-systolic volume, left atrial volume index, creatinine/eGFR, urine albumin-to-creatinine ratio (UACR), hemoglobin levels, proBNP, Troponin, and LV mass, all assessed at 6 months.

The efficacy parameters will be measured and collected at the specified 6-month timepoint using validated echocardiographic techniques and laboratory tests. The analysis will focus on quantifying the changes in these parameters from baseline to the end of the treatment period. The study is designed to provide a comprehensive evaluation of the effects of dapagliflozin on both systolic and diastolic cardiac function, as well as structural changes in the heart, in a population with varying stages of CKD.