Antiischemic Effects of Empagliflozin in Diabetic Patients With Refractory Angina
- 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
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 .
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
Group Intervention Description empagliflozin Empagliflozin 25 MG following a two-week washout and complete SAQ and exercise tolerance test patients gave 25 mg empagloflozin and therafter SAQ and ETT was done No drug Empagliflozin 25 MG following a two-week washout and complete SAQ and exercise tolerance test patients gave placebo and therafter SAQ and ETT was done
- Primary Outcome Measures
Name Time Method Seattle angina questionnaire 1 4 weeks improvement of angina symptoms
- Secondary Outcome Measures
Name Time Method Seattle angina questionnaire 2 4 weeks evaluation of Physical limitations, angina stability, treatment satisfaction, quality of life, and overall SAQ.
Seattle angina questionnaire 3 4 weeks evaluation of angina stability,
Seattle angina questionnaire 4 4 weeks evaluation of treatment satisfaction
Seattle angina questionnaire 5 4 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