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Antiischemic Effects of Empagliflozin in Diabetic Patients With Refractory Angina

Phase 4
Completed
Conditions
Diabetes Mellitus
Interventions
Registration Number
NCT04143321
Lead Sponsor
Isfahan University of Medical Sciences
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
75
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).

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
empagliflozinEmpagliflozin 25 MGfollowing a two-week washout and complete SAQ and exercise tolerance test patients gave 25 mg empagloflozin and therafter SAQ and ETT was done
No drugEmpagliflozin 25 MGfollowing a two-week washout and complete SAQ and exercise tolerance test patients gave placebo and therafter SAQ and ETT was done
Primary Outcome Measures
NameTimeMethod
Seattle angina questionnaire 14 weeks

improvement of angina symptoms

Secondary Outcome Measures
NameTimeMethod
Seattle angina questionnaire 24 weeks

evaluation of Physical limitations, angina stability, treatment satisfaction, quality of life, and overall SAQ.

Seattle angina questionnaire 34 weeks

evaluation of angina stability,

Seattle angina questionnaire 44 weeks

evaluation of treatment satisfaction

Seattle angina questionnaire 54 weeks

evaluation of quality of life

Trial Locations

Locations (1)

Cardiac rehabilitation research center

🇮🇷

Isfahan, Iran, Islamic Republic of

Cardiac rehabilitation research center
🇮🇷Isfahan, Iran, Islamic Republic of
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