Evaluation of Empagliflozin on Exercise Capacity in Patients with Hypertrophic Cardiomyopathy: A Randomized, Placebo-Controlled Trial

The primary objective of this study is to evaluate whether the administration of **empagliflozin** at a dosage of 10 mg daily over a 12-month period enhances exercise capacity in patients diagnosed with **hypertrophic cardiomyopathy**. This is clinically significant as improving exercise capacity can lead to better quality of life and potentially reduce morbidity in this patient population.

Secondary objectives include assessing whether the use of empagliflozin 10 mg daily for 12 months improves exercise capacity specifically in patients with hypertrophic cardiomyopathy and reduced left ventricular ejection fraction (EF <50%). This subgroup analysis is crucial for understanding the drug's efficacy in patients with more severe cardiac dysfunction.

The clinical trial focuses on individuals diagnosed with **hypertrophic cardiomyopathy**, aiming to evaluate the impact of empagliflozin on exercise capacity. The study population includes both male and female participants aged 18 years and older. The trial does not involve a vulnerable population. The sponsor has not provided the total number of participants. Participants were selected based on their diagnosis of hypertrophic cardiomyopathy and their ability to provide written, voluntary informed consent. The trial does not specify any particular lifestyle considerations such as diet or physical activity. Key inclusion criteria include a confirmed diagnosis of hypertrophic cardiomyopathy and an age of 18 years or older.

The clinical trial is designed to evaluate the efficacy of **empagliflozin** in patients diagnosed with **hypertrophic cardiomyopathy**. This study is a randomized, double-blind, placebo-controlled trial, which will span a duration of 12 months. Participants will be randomly assigned to receive either 10 mg of empagliflozin or a placebo, administered orally once daily. The primary objective is to assess whether empagliflozin improves exercise capacity, as measured by VO2 max, and the Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS) score after 12 months of treatment. Secondary objectives include evaluating the effect of empagliflozin on patients with reduced left ventricular ejection fraction.

The trial will commence with an inclusion visit, where participants will undergo screening to ensure they meet the eligibility criteria, which include providing written informed consent, having a confirmed diagnosis of hypertrophic cardiomyopathy, and being aged 18 years or older. Following successful screening, participants will be enrolled and randomized into the study. Throughout the trial, participants will attend regular follow-up visits to monitor their health status, adherence to the medication regimen, and any adverse events. These visits will also include assessments of exercise capacity and quality of life.

The end-of-study visit will occur at the conclusion of the 12-month treatment period, where final assessments will be conducted to evaluate the primary and secondary endpoints. Participant involvement is expected to last for the entire duration of the trial, approximately 12 months, unless early termination is warranted. Conditions that may lead to early withdrawal from the study include significant adverse events, non-compliance with the study protocol, or withdrawal of consent by the participant. The trial is conducted in accordance with ethical standards and regulatory requirements to ensure the safety and well-being of all participants.

The clinical trial involves the administration of **Jardiance** 10 mg film-coated tablets, which contain the active substance **empagliflozin**. The pharmaceutical form of this medication is a film-coated tablet, and it is administered orally. The dosage is set at 10 mg once daily, with a maximum treatment period of 12 months. The primary objective of the trial is to evaluate the efficacy of empagliflozin in improving exercise capacity in patients diagnosed with hypertrophic cardiomyopathy. The medication is manufactured by Boehringer Ingelheim International GmbH and is authorized for use in the European Union under the marketing authorization number EU/1/14/930/014.

In addition to the experimental treatment, the trial includes a **placebo** group. The placebo consists of microcrystalline cellulose and magnesium stearate, which are inactive substances used to mimic the appearance and administration of the active medication. The placebo is also administered in a form that is indistinguishable from the film-coated tablets of the active treatment, ensuring blinding of the study participants and investigators. The placebo is administered orally with the same frequency and duration as the active treatment, maintaining consistency in the dosing schedule across all study groups.

Efficacy in the clinical trial titled "The use of empagliflozin in patients with hypertrophic cardiomyopathy" will be assessed through primary and secondary endpoints. The primary endpoints include testing the null hypothesis that the mean VO₂ max and the Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS) value, both measured 12 months after randomization, are the same in the treatment group and the placebo group. The secondary endpoint involves testing the null hypothesis that the mean VO₂ max value, measured 12 months after randomization, is the same in the treatment group and the placebo group among patients with reduced left ventricular ejection fraction.

The efficacy parameters will be collected and analyzed at the 12-month mark following randomization. The VO₂ max, a measure of exercise capacity, and the KCCQ-OS, a patient-reported outcome measure assessing health status in patients with heart failure, will be utilized as tools for efficacy assessment. These assessments will provide insights into the impact of empagliflozin 10 mg daily on exercise capacity and overall health status in patients with **hypertrophic cardiomyopathy** over the course of the trial.