The Efficacy of Enavogliflozin in Heart Failure With Preserved Ejection Fraction
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age19+
SponsorSamsung Medical Center
About this trial
The aim of prospective, open label, single center, randomized controlled trial is to investigate the efficacy of enavogliflozin on exercise performance, diastolic dysfunction, and quality of life in patients with heart failure with preserved ejection fraction (HFpEF).
Eligibility criteria
Qualifiers
Left ventricular ejection fraction (LVEF) ≥50%
NT-proBNP ≥220 pg/mL or BNP ≥80 pg/mL, if in sinus rhythm NT-proBNP ≥660 pg/mL or BNP ≥240 pg/mL, if in atrial fibrillation
Satisfying either noninvasive or invasive criteria I. Noninvasive: Echocardiography with at least one of the following criteria
LAVI ≥34 ml/m2
Disqualifiers
Unwillingness or inability to comply with the procedures described in this protocol
The ability to walk is, in the investigator's opinion, clearly limited by joint disease or other locomotor problems or lung diseases rather than by cardiorespiratory fitness
NYHA IV dyspnea
Type 1 diabetes mellitus
Trial design
Treatments tested in this trial
- SGLT2 inhibitor
Treatment groups
154 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov