Evaluating Metabolic Mechanisms of Ertugliflozin in Diabetes & Heart Failure

• Status: Unknown status
• Trial end date: 2021-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospitals Cleveland Medical Center
• Treatments: 5-(4-chloro-3-(4-ethoxybenzyl)phenyl)-1-hydroxymethyl-6,8-dioxabicyclo(3.2.1)octane-2,3,4-triol; Ertugliflozin

Criteria

Inclusion Criteria:

• 1. Age > 18 years old but < 75 years old 2. No HF hospitalization within 6 months 3. Overweight or Obesity defined as BMI > 29 but < 40 4. Insulin resistance or T2DM and on oral diabetes agents other than SGLT2i (HgbA1c > 6.5% and < 10.5%) 5. EF calculated based on a recent echo/cath/nuclear study at screening (pre- enrollment) > 50% 6. Stable HFpEF (HF with preserved ejection fraction) medications use of 3-6 months with no plans to changes or add medications for at least 12 weeks (course of the study)

Exclusion Criteria:

• 1. Acute HFpEF hospitalization within 6 months of enrollment. 2. CKD stage 4 or 5 (eGFR < 30 ml/min by CKD-EPI equation). 3. Other known causes of HF including poorly controlled hypertension (SBP > 160 mm Hg) or ischemic cardiomyopathy (etc). 4. Anemia (Hgb < 11.5 mg/dL for women and < 12.5 mg/dL for men) or severe thrombocytopenia (platelets < 50,000 mm3) 5. Anticipated changing of HF medication during anticipated study period. 6. HFREF (LV EF < 50%). 7. 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. 8. Contraindications to MRI (metallic implants, severe claustrophobia) or treadmill exercise (limb amputation, severe osteoarthritis or equivalent functional mechanical limitation).