SGLT2 Inhibition in Diabetes and Heart Failure

Completed

Conditions studied: Diabetes Mellitus, Type 2, Heart Failure, Systolic

In brief

To determine the effects of SGLT2 inhibition with empagliflozin on cardio-respiratory fitness in patients with systolic heart failure.

Key facts

Study ID

NCT02862067

Run by

Virginia Commonwealth University

People needed

18

Starts

2016-07-01

Expected to finish

2018-01-16

Last updated by the study team

2018-07-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Virginia Commonwealth University — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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