Health TrialsbyHealthPanel

The Efficacy of Enavogliflozin in Heart Failure With Preserved Ejection Fraction

ConditionHeart Failure, 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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • SGLT2 inhibitor

    Drug

    Enavogliflozin (0.3mg oral tablet once daily) will be administrated.

Treatment groups

154 Participants
are divided into 2 treatment groups
Group A: SGLT2 inhibitor groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Change in peak oxygen consumption (VO2)

Change in peak oxygen consumption (VO2) from baseline to week 24

Time frame
Week 24

Secondary outcomes

1

Change in minute ventilation to carbon dioxide output ratio (VE/VCO2 slope)

Change in minute ventilation to carbon dioxide output ratio (VE/VCO2 slope) from baseline to week 24

Time frame
Week 24
2

Change in Left atrial volume index (LAVI) before and after maximal exercise

Change in LAVI before and after maximal exercise from baseline to week 24

Time frame
Week 24
3

Change in Lateral Early diastolic transmitral filling velocity over early diastolic relaxation velocity at mitral annulus (E/e') before and after maximal exercise

Change in Lateral E/e' before and after maximal exercise from baseline to week 24

Time frame
Week 24
4

Change in Left ventricular mass index (LVMI) before and after maximal exercise

Change in LVMI before and after maximal exercise from baseline to week 24

Time frame
Week 24

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Samsung Medical Center

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: