Diabetes Mellitus, Type 2, Heart Failure, Systolic
Conditions
Keywords
SGLT2, type 2 diabetes mellitus, systolic heart failure, heart failure with reduced ejection fraction
Brief summary
To determine the effects of SGLT2 inhibition with empagliflozin on cardio-respiratory fitness in patients with systolic heart failure.
Detailed description
The investigators hypothesize that Sodium-GLucose coTransporters (SGLT)-2 inhibition will improve cardio-respiratory fitness (CRF) in patients with systolic heart failure. Participants treated with SGLT2 inhibitor Empagliflozin as standard of care will undergo assessments described below. The investigators will measure CRF with a validated cardiopulmonary exercise test at baseline and after 4 weeks of treatment received as standard of care, to determine whether SGLT2 inhibition improves cardio-respiratory fitness assessed by changes in peak oxygen consumption (VO2)(mL/kg/min) and minute ventilation (VE)/carbon dioxide production (VCO2) slope, powerful independent clinical predictors of mortality in HF.
Interventions
Assessment of cardiorespiratory fitness
Sponsors
American Heart Association
Virginia Commonwealth University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Confirmed clinical diagnosis of stable HF (NYHA class II-III) on maximally tolerated HF medical regimen including angiotensin-inhibitors, beta-adrenergic blockers, and loop diuretics * Reduced left ventricular systolic function (LVEF\<50%) documented in the prior 12 months * Poorly controlled T2DM (HbA1c levels between 6.5% and 10.0%) * 18 years old and older.
Exclusion criteria
* Type I diabetes; * Type II diabetes with episodes of severe hypoglycemia \<50 mg/dl by history, frequent changes in anti-diabetic regimen class in the past 3 months or with a prior episode of diabetic ketoacidosis (any time); * Open label treatment with SGLT2 inhibitors (within the past month); * Treatment with thiazolidinedione (within the past month), which may induce volume and sodium retention; * Chronic Kidney Disease (GFR\<45 ml/kg\*min); * Uncontrolled thyroid dysfunction (TSH\<0.4\>4.5 mcIU/ml); * Pregnancy or of child-bearing potential; * Active or recent (within 2 weeks) genital/urinal infection; * Concomitant conditions or treatment which would affect completion or interpretation of the study including physical inability to walk or run on a treadmill such as decompensated HF (edema, NYHA class IV), significant ischemic heart disease, angina, arterial hypotension (BP systolic \<90 mmHg), orthostatic arterial hypotension, arterial hypertension (resting BP systolic \>160 mmHg), atrial fibrillation with rapid ventricular response, severe valvular disease, severe chronic obstructive or restrictive pulmonary disease, moderate- severe anemia (Hgb\<10 g/dl); * Abnormal BP or heart rate response, angina or ECG changes (ischemia or arrhy- thmias) occurring during baseline cardio-pulmonary exercise testing; * Chronic use of oral corticosteroids; * Inability to give informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SGLT2 inhibition effects on cardiorespiratory fitness (CRF). | 4 weeks | To measure the effects of Empagliflozin on cardiorespiratory fitness in patients with type 2 diabetes and heart failure with reduced ejection fraction or systolic heart failure. The effects on CRF are determined by measuring changes in peak VO2 (mL/kg/min) and the VE/VCO2 slope. |
Countries
United States
Outcome results
None listed