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A Randomized Active-Control Double-Blinded Study to Evaluate the Treatment of Diabetes in Patients With Systolic Heart Failure
Investigator Initiated Study to study the effects of Canagliflozin 100 milligrams (mg) vs Sitagliptin 100 mg on parameters of aerobic exercise capacity (peak oxygen consumption \[VO2\]) and ventilator efficiency (minute ventilation \[VE\]/carbon dioxide production \[VCO2\] slope) at cardiopulmonary exercise test (CPET) after 12 weeks of active treatment (primary endpoints). Blood pressure (BP), body water content, body composition, cardiac function, and diet will be also measured (secondary endpoints).
Details
| Lead sponsor | Virginia Commonwealth University |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 36 |
| Start date | 2016-10 |
| Completion | 2018-09 |
Conditions
- Heart Failure, Systolic
- Diabetes Mellitus, Type 2
Interventions
- Canagliflozin
- Sitagliptin
Primary outcomes
- Change From Baseline Aerobic Exercise Capacity at 12 Weeks — baseline and 12 weeks
Peak oxygen consumption (VO2) measured by maximal cardiopulmonary exercise test - Change From Baseline Ventilatory Efficiency at 12 Weeks — baseline and 12 weeks
Minute ventilation (VE) relative to CO2 production (VCO2) slope measured by cardiopulmonary exercise test
Countries
United States