NIPH Clinical Trials Search

Preservation of Skeletal Muscle Mass with SGLT2 inhibitors under Nutritional Assessment and/or Intervention in Underweight HFpEF

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	heart failure with preserved ejection fraction
Date of first enrollment	04/12/2025
Target sample size	36
Countries of recruitment
Study type	Interventional
Intervention(s)	Empagliflozin (10 mg once daily) will be administered for a period of 4 months, in addition to standard heart failure treatment.

Outcome(s)

Primary Outcome

Change in skeletal muscle mass index from baseline to 4 months

Secondary Outcome

Change in skeletal muscle mass from baseline to 4 months after intervention Change in fat mass and lean body mass from baseline to 4 months after intervention Change in GNRI from baseline to 4 months after intervention Change in NT-proBNP from baseline to 4 months after intervention Change in skeletal muscle mass and skeletal muscle mass index from baseline to 12 months after intervention Change in fat mass and lean body mass from baseline to 12 months after intervention Change in GNRI from baseline to 12 months after intervention Change in NT-proBNP from baseline to 12 months after intervention Change in E/e' ratio from baseline to 12 months after intervention Change in left atrial volume index from baseline to 12 months after intervention

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	Not applicable
Gender	Both
Include criteria	Participants must meet all of the following criteria Patients aged 20 years or older Patients diagnosed with heart failure with preserved ejection fraction (HFpEF) Patients with a body mass index (BMI) of less than 22 kg/m2 Patients who have provided written informed consent to participate in the study
Exclude criteria	Participants will be excluded from the study if they meet any of the following criteria: Patients with significant left-sided valvular disease, severe coronary artery disease, decompensated heart failure, or cardiomyopathy Patients with comorbid conditions unrelated to heart failure that are expected to significantly limit life expectancy to less than one year Patients with implanted medical devices such as pacemakers or implantable cardioverter defibrillators (ICDs) Patients who are currently taking SGLT2 inhibitors Patients with type 1 diabetes mellitus Patients with eGFR less than 20 mL/min/1.73 m2 Patients for whom empagliflozin is contraindicated according to the drug information Patients whose dietary intake (amount or content) is judged by the investigator to be unstable or to vary significantly from day to day Patients who are currently participating in another interventional study Any other patients deemed unsuitable for the study at the discretion of the investigator