Evaluating Metabolic Mechanisms of Ertugliflozin in Diabetes & Heart Failure
Condition: Heart Failure, Diastolic; Diabetes Mellitus, Type 2
MeSH terms: Heart Failure; Heart Failure, Diastolic; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Ertugliflozin 5 mg; Placebo oral tablet
Intervention description: Ertugliflozin 5 mg once a day for 12 weeks; Placebo oral tablet once a day for 12 weeks
Intervention MeSH terms: Ertugliflozin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel assignment, active controlled, single center experimental design.
Masking: Double (Participant, Care Provider)
Masking description: Single-blind study
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: ertugliflozin; SGLT2 inhibtion; Cardiovascular Diseases; Sodium-Glucose Transporter 2 Inhibitors; Glucose Metabolism Disorders; Physiological Effects of Drugs; Diabetes Mellitus; Diabetes Mellitus, Type 2; Endocrine System Diseases

Summary:

      This clinical trial will determine if subjects with heart failure with preserved ejection
      fraction (HFpEF) and type 2 diabetes mellitus (DM2) receiving sodium-glucose cotransporter 2
      (SGLTi2) inhibitor therapy (ertugliflozin) alters cardiac metabolism compared to placebo in a
      single blinded (to subject), randomized, parallel group, active controlled, single center
      experimental design.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age > 18 years old but < 75 years old

          -  No HF hospitalization within 6 months

          -  Overweight or Obesity defined as BMI > 29 but < 42

          -  History of insulin resistance or T2DM and on oral diabetes agents other than SGLT2i
             (HgbA1c > 5.8% and < 10.5%)

          -  EF calculated based on a recent echo/cath/nuclear study at screening (pre-enrollment)
             > 50%

          -  Stable HFpEF (HF with preserved ejection fraction) medications use of 3 months with no
             plans to changes or add medications for at least 12 weeks course of the study)

        Exclusion Criteria:

          -  Acute HFpEF hospitalization within 6 months of enrollment.

          -  CKD stage 4 or 5 (eGFR < 30 ml/min by CKD-EPI equation).

          -  Other known causes of HF including poorly controlled hypertension (SBP >160 mm Hg) or
             ischemic cardiomyopathy (etc).

          -  Anemia (Hgb < 11.0 mg/dL for women and < 12.0 mg/dL for men) or severe
             thrombocytopenia (platelets < 50,000 mm3)

          -  Anticipated changing of HF medication during anticipated study period.

          -  HFREF (LV EF < 50%).

          -  Acute coronary syndrome, transient ischemic attack, CVA or critical limb ischemia
             during the last 6 months or coronary/peripheral revascularization within the last 3
             months. Severe life threatening illness or live expectancy < 6 months.

          -  Contraindications to MRI (metallic implants, severe claustrophobia) or treadmill
             exercise (limb amputation, severe osteoarthritis or equivalent functional mechanical
             limitation).