Antiischemic Effects of Empagliflozin in Diabetic Patients With Refractory Angina
October 26, 2019 updated by: Masoumeh Sadeghi, Isfahan University of Medical Sciences
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)
this study was aimed to evaluation of antiangial effect of a new fda drug approval on angina in diabetic patient with refractory angina
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
75
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Isfahan, Iran, Islamic Republic of
- Cardiac rehabilitation research center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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).
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Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: empagliflozin
following a two-week washout and complete SAQ and exercise tolerance test patients gave 25 mg empagloflozin and therafter SAQ and ETT was done
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after washout period and EST and SAQ patients gave 25 mg Empagliflozin daily in experimental group
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Placebo Comparator: No drug
following a two-week washout and complete SAQ and exercise tolerance test patients gave placebo and therafter SAQ and ETT was done
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after washout period and EST and SAQ patients gave 25 mg Empagliflozin daily in experimental group
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Seattle angina questionnaire 1
Time Frame: 4 weeks
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improvement of angina symptoms
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4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Seattle angina questionnaire 2
Time Frame: 4 weeks
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evaluation of Physical limitations, angina stability, treatment satisfaction, quality of life, and overall SAQ.
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4 weeks
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Seattle angina questionnaire 3
Time Frame: 4 weeks
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evaluation of angina stability,
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4 weeks
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Seattle angina questionnaire 4
Time Frame: 4 weeks
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evaluation of treatment satisfaction
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4 weeks
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Seattle angina questionnaire 5
Time Frame: 4 weeks
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evaluation of quality of life
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4 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Exercise tolerance test 1
Time Frame: 4 weeks
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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)
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4 weeks
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Exercise tolerance test 2
Time Frame: 4 weeks
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evaluation of time to angina
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4 weeks
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Exercise tolerance test 3
Time Frame: 4 weeks
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evaluation of maximum st depression
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4 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 10, 2018
Primary Completion (Actual)
April 15, 2019
Study Completion (Actual)
May 23, 2019
Study Registration Dates
First Submitted
October 13, 2019
First Submitted That Met QC Criteria
October 26, 2019
First Posted (Actual)
October 29, 2019
Study Record Updates
Last Update Posted (Actual)
October 29, 2019
Last Update Submitted That Met QC Criteria
October 26, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EMPT-ANGIN
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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