New Generation of Medical Research

Heart Failure

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Patients must meet all of the following criteria to be eligible for the study:
1. Diagnosis of Type 2 Diabetes Mellitus (T2DM)
2. One of the following age-related criteria:
• Age ≥ 60 years
OR
• Age ≥ 40 years AND at least 1 of the following 7 risk factors:
o Hemoglobin A1c (HbA1c) > 7.5% (there is no requirement for a minimum HbA1c level for patients who have at least one of the other 6 risk factors listed below)
o Duration of diabetes ≥ 10 years
o High-sensitivity troponin T (HsTnT) >15.0 pg/mL for men and >10.0 pg/mL for women
o Body mass index (BMI) >30 kg/m2
o eGFR < 60 mL/min/1.73 m2
o Prior diagnosis of diabetic neuropathy
o Prior diagnosis of diabetic retinopathy

3. NT-proBNP > 125 pg/mL (≥ 100 pg/mL if BMI > 30 kg/m2)

4. Echocardiographic demonstration of the following, as confirmed by the central core lab:
• Left Ventricular Ejection Fraction (LVEF)  45%
AND
• At least 2 of the following 5 abnormalities:
o Global longitudinal strain (GLS) <16%
o Left ventricular hypertrophy (LVH) defined as left ventricular mass index (LVMI) > 109 g/m2 in women and >132 g/m2 in men

o Left atrial enlargement (LAE) defined as left atrial volume index (LAVi) ≥ 34 mL/m2
o Diastolic Dysfunction defined as E/E’ ≥ 13
o Right ventricular systolic pressure (RVSP) > 35 mmHg
5. CPET demonstration of both, as confirmed by the CPET core lab:
• Impaired functional capacity, i.e., Peak VO2 < 75% of predicted
• Ability of maximal effort, i.e., achieve a RER ≥1.05