Clinical trial NCT04143321: Antiischemic Effects of Empagliflozin in Diabetic Patients With Refractory Angina
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus
Keywords: diabetes mellitus-refractory angina-empagliflozine
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2019-10-29
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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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Primary outcomes:
measure: Seattle angina questionnaire 1
timeFrame: 4 weeks
Secondary outcomes:
measure: Seattle angina questionnaire 2
timeFrame: 4 weeks
measure: Seattle angina questionnaire 3
timeFrame: 4 weeks
measure: Seattle angina questionnaire 4
timeFrame: 4 weeks
measure: Seattle angina questionnaire 5
timeFrame: 4 weeks
Other outcomes:
measure: Exercise tolerance test 1
timeFrame: 4 weeks
measure: Exercise tolerance test 2
timeFrame: 4 weeks
measure: Exercise tolerance test 3
timeFrame: 4 weeks
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Cardiac rehabilitation research center
Study officials:
References: