Antiischemic Effects of Empagliflozin in Diabetic Patients With Refractory Angina

Study Overview
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Brief Summary
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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
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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.

Official Title
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Anti-anginal and Antiischemic Effects of Empagliflozin in Diabetic Patients With Refractory Angina:A Phase III, Multicentre, Randomised, Parallel Group, Double Blind Cardiovascular Safety Study of BI 10773 (10 mg Administered Orally Once Daily) Compared to Placebo in Type 2 Diabetes Mellitus Patients With Refractory Angina(EMPT-ANGIN TRIAL)

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Drug: Empagliflozin 25 MG


Participation Criteria
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Eligibility Criteria
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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). -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: empagliflozin<br>following a two-week washout and complete SAQ and exercise tolerance test patients gave 25 mg empagloflozin and therafter SAQ and ETT was done | Drug: Empagliflozin 25 MG<br>* after washout period and EST and SAQ patients gave 25 mg Empagliflozin daily in experimental group<br>|
| Placebo Comparator: No drug<br>following a two-week washout and complete SAQ and exercise tolerance test patients gave placebo and therafter SAQ and ETT was done | Drug: Empagliflozin 25 MG<br>* after washout period and EST and SAQ patients gave 25 mg Empagliflozin daily in experimental group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seattle angina questionnaire 1 | improvement of angina symptoms | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes mellitus-refractory angina-empagliflozine