Empagliflozin in improving exercise tolerance in HFpEF: study protocol for an open-label, randomized controlled study

Area of Science:

• Cardiology
• Pharmacology
• Exercise Physiology

Background:

• Heart failure with preserved ejection fraction (HFpEF) affects many patients, yet treatment options remain limited.
• Empagliflozin, a sodium glucose cotransporter 2 inhibitor (SGLT2i), shows potential, but its impact on HFpEF exercise tolerance requires further study.

Purpose of the Study:

• To evaluate the efficacy and safety of empagliflozin in improving exercise tolerance in non-diabetic patients with HFpEF.
• To assess the impact of empagliflozin on various cardiopulmonary exercise testing parameters and quality of life indicators.

Main Methods:

• A single-center, open-label, randomized controlled trial involving 86 patients with HFpEF (ejection fraction >40%, NYHA class II-III).
• Patients were randomized (1:1) to receive empagliflozin (10 mg daily) or continue their existing treatment for 12 weeks.
• The primary endpoint was the change in peak oxygen uptake (peak VO2) assessed by cardiopulmonary exercise testing (CPET).

Main Results:

• The study primarily focused on changes in peak oxygen uptake (peak VO2) as the main measure of exercise tolerance.
• Secondary endpoints included other CPET parameters, echocardiographic findings, biomarker levels (NT-proBNP, liver enzymes, eGFR), and quality of life scores.

Conclusions:

• Peak oxygen uptake (peak VO2) was utilized as the gold standard to assess empagliflozin's efficacy and safety in non-diabetic HFpEF patients.
• The study aims to provide objective data on the improvement of quality of life in HFpEF patients treated with SGLT2 inhibitors.