| Trial ID: | L3151 |
| Source ID: | NCT04071626
|
| Associated Drug: |
Ertugliflozin 5 Mg
|
| Title: |
Evaluating Metabolic Mechanisms of Ertugliflozin in Diabetes & Heart Failure
|
| Acronym: |
EMMED-HF
|
| Status: |
TERMINATED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT04071626/results
|
| Conditions: |
Heart Failure, Diastolic|Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Ertugliflozin 5 mg|DRUG: Placebo oral tablet
|
| Outcome Measures: |
Primary: Peak VO2, ml/kg/Min, as Measured by Metabolic Gas Exchange, The difference in peak oxygen uptake as measured by peak VO2 (ml/kg/min) between ertugliflozin and placebo as measured at baseline and after 12 weeks of treatment, 12 weeks | Secondary: Left Ventricular Mass Index (gm/m2), as Measured by Cardiac MRI, The difference in LV mass index (gm/m2) measured by cardiac MRI between ertugliflozin and placebo as measured at baseline and after 12 weeks of treatment, 12 weeks|Serum Ketone Bodies (Betahydroxybutyrate), The difference in serum ketone bodies (betahydroxybutyrate) levels between ertugliflozin and placebo as measured at baseline and after 12 weeks of treatment, 12 weeks
|
| Sponsor/Collaborators: |
Sponsor: University Hospitals Cleveland Medical Center
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
9
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: TREATMENT
|
| Start Date: |
2020-03-01
|
| Completion Date: |
2023-01-11
|
| Results First Posted: |
2023-12-13
|
| Last Update Posted: |
2023-12-13
|
| Locations: |
University Hospitals Cleveland Medical Center, Cleveland, Ohio, 44106, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT04071626
|
