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Preservation of Skeletal Muscle Mass with SGLT2 inhibitors under Nutritional Assessment and/or Intervention in Underweight HFpEF (The PRESERVE-HF trial)

Preservation of Skeletal Muscle Mass with SGLT2 inhibitors under Nutritional Assessment and/or Intervention in Underweight HFpEF (The PRESERVE-HF trial)

Obokata Masaru

Gunma University Graduate School of Medicine

3-39-15 Showa-machi, Maebashi, Gunma , Japan

obokata.masaru@gunma-u.ac.jp

Obokata Masaru

Gunma University Graduate School of Medicine

3-39-15 Showa-machi, Maebashi, Gunma , Japan

+81-27-220-8145

obokata.masaru@gunma-u.ac.jp

Recruiting

Dec. 04, 2025

Interventional

randomized controlled trial

open(masking not used)

no treatment control/standard of care control

parallel assignment

treatment purpose

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

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

Both

heart failure with preserved ejection fraction

Empagliflozin (10 mg once daily) will be administered for a period of 4 months, in addition to standard heart failure treatment.

Heart failure with preserved ejection fraction, SGLT2 inhibitors, sarcopenia, nutrition

Empagliflozin

D006333

D000077203

Change in skeletal muscle mass index from baseline to 4 months

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

+81-27-220-8740

Dec. 03, 2025

No

none