Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 12:44 AM
NCT ID:
NCT02862067
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02862067
Study Brief:
Protocol Section:
NCT02862067