Antiischemic Effects of Empagliflozin in Diabetic Patients With Refractory Angina

NCT04143321 | Completed Phase 4 DMC

• 1 other identifier: EMPT-ANGIN
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetes Mellitus

Keywords

diabetes mellitus-refractory angina-empagliflozine

Outcome Measures

Primary Outcomes (1)

• Seattle angina questionnaire 1

  improvement of angina symptoms

  4 weeks

Secondary Outcomes (4)

• Seattle angina questionnaire 2

  4 weeks

• Seattle angina questionnaire 3

  4 weeks

• Seattle angina questionnaire 4

  4 weeks

• Seattle angina questionnaire 5

  4 weeks

Other Outcomes (3)

• Exercise tolerance test 1

  4 weeks

• Exercise tolerance test 2

  4 weeks

• Exercise tolerance test 3

  4 weeks

Study Arms (2)

empagliflozin

EXPERIMENTAL

following a two-week washout and complete SAQ and exercise tolerance test patients gave 25 mg empagloflozin and therafter SAQ and ETT was done

Drug: Empagliflozin 25 MG

No drug

PLACEBO COMPARATOR

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

Drug: Empagliflozin 25 MG

Interventions

Empagliflozin 25 MG DRUG

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

No drug; empagliflozin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .

You may not qualify if:

• 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).

Sponsors & Collaborators

• Isfahan University of Medical Sciences: lead

Study Sites (1)

Cardiac rehabilitation research center

Isfahan, Iran

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor of cardiology

Study Record Dates

• First Submitted: October 13, 2019
• First Posted: October 29, 2019
• Study Start: September 10, 2018
• Primary Completion: April 15, 2019
• Study Completion: May 23, 2019
• Last Updated: October 29, 2019

Record last verified: 2019-10

Locations

IR (1)