Antiischemic Effects of Empagliflozin in Diabetic Patients With Refractory Angina

Diabetes Mellitus Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04143321
• Other study ID #: EMPT-ANGIN
• Status: Completed
• Phase: Phase 4
• Start date: September 10, 2018
• Est. completion date: May 23, 2019

Study information

• Verified date: October 2019
• Source: Isfahan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

this study was aimed to evaluation of antiangial effect of a new fda drug approval on angina in diabetic patient with refractory angina

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: May 23, 2019
• Est. primary completion date: April 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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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Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Drug:
• Empagliflozin 25 MG
after washout period and EST and SAQ patients gave 25 mg Empagliflozin daily in experimental group

Locations

Country	Name	City	State
Iran, Islamic Republic of	Cardiac rehabilitation research center	Isfahan

Sponsors (1)

Lead Sponsor	Collaborator
Isfahan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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
Other	Exercise tolerance test 2	evaluation of time to angina	4 weeks
Other	Exercise tolerance test 3	evaluation of maximum st depression	4 weeks
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
Secondary	Seattle angina questionnaire 3	evaluation of angina stability,	4 weeks
Secondary	Seattle angina questionnaire 4	evaluation of treatment satisfaction	4 weeks
Secondary	Seattle angina questionnaire 5	evaluation of quality of life	4 weeks