Clinical Trial Details
| Trial ID: | L4675 |
| Source ID: | NCT04143321 |
| Associated Drug: | Empagliflozin 25 Mg |
| Title: | Antiischemic Effects of Empagliflozin in Diabetic Patients With Refractory Angina |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Diabetes Mellitus |
| Interventions: | DRUG: Empagliflozin 25 MG |
| Outcome Measures: | Primary: Seattle angina questionnaire 1, improvement of angina symptoms, 4 weeks | Secondary: Seattle angina questionnaire 2, evaluation of Physical limitations, angina stability, treatment satisfaction, quality of life, and overall SAQ., 4 weeks|Seattle angina questionnaire 3, evaluation of angina stability,, 4 weeks|Seattle angina questionnaire 4, evaluation of treatment satisfaction, 4 weeks|Seattle angina questionnaire 5, evaluation of quality of life, 4 weeks | Other: Exercise tolerance test 1, evauation of functional calss Empaglofolzine vs placebo on treadmill exercise duration, times to angina onset and to 1mm ST segment depression and mean of heart rate recovery(HRR), 4 weeks|Exercise tolerance test 2, evaluation of time to angina, 4 weeks|Exercise tolerance test 3, evaluation of maximum st depression, 4 weeks |
| Sponsor/Collaborators: | Sponsor: Isfahan University of Medical Sciences |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE4 |
| Enrollment: | 75 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
| Start Date: | 2018-09-10 |
| Completion Date: | 2019-05-23 |
| Results First Posted: | |
| Last Update Posted: | 2019-10-29 |
| Locations: | Cardiac rehabilitation research center, Isfahan, Iran, Islamic Republic of |
| URL: | https://clinicaltrials.gov/show/NCT04143321 |
