Status:
TERMINATED
Evaluating Metabolic Mechanisms of Ertugliflozin in Diabetes & Heart Failure
Lead Sponsor:
University Hospitals Cleveland Medical Center
Conditions:
Heart Failure, Diastolic
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief 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) inhibito...
Detailed Description
The results of recent sodium-glucose cotransporter 2 (SGLT2) inhibitor therapy clinical trials demonstrate clinically significant reductions in cardiovascular endpoints (myocardial infarction, cardiac...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
March 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 11 2023
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT04071626
Start Date
March 1 2020
End Date
January 11 2023
Last Update
December 13 2023
Active Locations (1)
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1
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106