Diabetes Mellitus
Conditions
Keywords
diabetes mellitus-refractory angina-empagliflozine
Brief summary
this study was aimed to evaluation of antiangial effect of a new fda drug approval on angina in diabetic patient with refractory angina
Detailed description
This was a prospective, double-blind, randomized pilot trial in which a total of 75 subjects were enrolled with T2DM and refractory angina, despite using conventional anti-anginal agents; and were randomly assigned to group A(Empagliflozin group) or B(placebo group) by blinded envelopes method. the study was conducted in two tertiary centers in Isfahan, Iran. The protocol of the study was revised and approved by the institutional ethics committee of Isfahan University of Medical Sciences; and each patient provided an informed consent before participating in the study. The primary aim of the trial was to examine the efficacy of Empagliflozin versus placebo on angina frequency in subjects with T2DM, CAD, and chronic stable angina who remain symptomatic, despite treatment with either one or two anti-anginal agents.The secondary outcome of this study was the evaluation of Physical limitations, angina stability, treatment satisfaction, quality of life, and overall SAQ andeffects o Empaglofolzine vs placebo on treadmill exercise duration, times to angina onset and to 1mm ST segment depression and mean of heart rate recovery(HRR) prior to randomization and after 6 weeks of treatment at peak drug level.
Interventions
DRUGEmpagliflozin 25 MG
after washout period and EST and SAQ patients gave 25 mg Empagliflozin daily in experimental group
Sponsors
Isfahan University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1- T2DM patients over 18 years of age with CAD, who have had minimum 3-month refractory Angina Pectoris (AP) in spite of using full medical treatment , and were not suitable candidates for revascularization or CABG and reproducible angina, ischemic ST-segment depression of at least 1 mm and limited exercise capacity on treadmill testing (3-9 minutes on a modified Bruce protocol) while receiving full medical treatment .
Exclusion criteria
1- New York Heart Association functional class III to IV heart failure symptoms, 2- acute coronary syndrome in the past 2 months, 3-any coronary revascularization during the study period, 4- stroke or transient ischemic attack 5- hepatic or renal impairment, 6-prior treatment with Empagliflozin 7- any relative or absolute contraindication to exercise test or specific condition that preclude accurate interpretation of the electrocardiogram(eg,Left bundle branch block(LBBB),resting ST depression more than 1 mm, pre-excitation or digoxin use). \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Seattle angina questionnaire 1 | 4 weeks | improvement of angina symptoms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Seattle angina questionnaire 3 | 4 weeks | evaluation of angina stability, |
| Seattle angina questionnaire 2 | 4 weeks | evaluation of Physical limitations, angina stability, treatment satisfaction, quality of life, and overall SAQ. |
| Seattle angina questionnaire 4 | 4 weeks | evaluation of treatment satisfaction |
| Seattle angina questionnaire 5 | 4 weeks | evaluation of quality of life |
Other
| Measure | Time frame | Description |
|---|---|---|
| Exercise tolerance test 3 | 4 weeks | evaluation of maximum st depression |
| Exercise tolerance test 2 | 4 weeks | evaluation of time to angina |
| Exercise tolerance test 1 | 4 weeks | 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) |
Countries
Iran
Outcome results
None listed