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 @ 4:48 AM
Ignite Modification Date:
2025-12-25 @ 4:48 AM
NCT ID:
NCT02920918
Eligibility Criteria:
Major Inclusion Criteria:
* Symptomatic stable heart failure (New York Heart Association (NYHA) functional classification II-III) with reduced left ventricular ejection fraction (LVEF) ≤40%
* Peak exercise limited by shortness of breath and associated with a respiratory exchange ratio (RER) \>1.00 (reflecting maximal aerobic effort);
* Poorly controlled Type 2 Diabetes Mellitus (T2DM)(HbA1c levels between 7.0% and 10.0% if on a treatment regimen including insulin, or between 6.5% and 10.0% if not on an insulin regimen);
* Eighteen years of age or older.
Major Exclusion Criteria:
* Type I diabetes;
* Open label treatment with Sodium-GLucose coTransporter (SGLT)-2 inhibitors (within the past 3 months);
* Current treatment with thiazolidinedione (within the past 3 months);
* Chronic Renal Disease defined as Glomerular Filtration Rate (GFR) \<50 ml•min-1/1.73m2 according to local laboratory
* Pregnancy or of child-bearing potential or lactating;
* Active or recent (within 2 weeks) genital/urinary infection;
* Concomitant conditions or treatment which would affect completion or interpretation of the study (i.e, physical inability to walk or run on a treadmill
* Inability to give informed consent.
Exclusion criteria specific to the cardiac magnetic resonance (CMR) substudy.
* Estimated GFR \<60 ml•min-1/1.73m2
* Implantable cardioverter defibrillator, pacemaker or other implantable metal device not compatible with CMR scanning;
* Severe claustrophobia, inability to lay flat for up to 60 minutes, or other contraindication to CMR scanning.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02920918
Study Brief:
Protocol Section:
NCT02920918