Antiischemic Effects of Empagliflozin in Diabetic Patients With Refractory Angina

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-10

Study Completion Date

2019-05-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Empagliflozin as a Modulator of Systemic Vascular Resistance and Cardiac Output in Patients With Type 2 Diabetes

NCT03132181

Diabetes Mellitus Type 2 (T2DM)

COMPLETED PHASE2

Evaluation of the Effect of SGLT-2 Inhibitors on Cardiac Remodeling in Post Myocardial Infarction Patients

NCT05335629

Myocardial Infarction Diabetes Mellitus, Type 2 Myocardial Remodeling, Ventricular

COMPLETED NA

Effects of Empagliflozin on Cardiac Structure in Patients With Type 2 Diabetes

NCT02998970

Diabetes Cardiovascular Disease

UNKNOWN PHASE4

Effect of Empagliflozin on Quality of Life in Chronic Heart Failure Patients With Diabetes Mellitus Type II

NCT06706791

Chronic Heart Failure

RECRUITING PHASE4

Effect of Empagliflozin on Urinary Excretion of Adenosine and Osteocyte Function in Patients With Chronic Kidney Disease

NCT04961931

Chronic Kidney Disease stage3

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Empagliflozin 25 MG

Intervention Type DRUG

after washout period and EST and SAQ patients gave 25 mg Empagliflozin daily in experimental group

No drug

following a two-week washout and complete SAQ and exercise tolerance test patients gave placebo and therafter SAQ and ETT was done

Group Type PLACEBO_COMPARATOR

Empagliflozin 25 MG

Intervention Type DRUG

after washout period and EST and SAQ patients gave 25 mg Empagliflozin daily in experimental group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Empagliflozin 25 MG

after washout period and EST and SAQ patients gave 25 mg Empagliflozin daily in experimental group

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).

\-

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No