?Effect of Empagliflozin in ?heart failure preserved ejection fractio

Phase 3

Recruiting

• Conditions: Heart Failure preserved Ejection Fraction.; Left ventricular failure; I50.1

• Registration Number: IRCT20190122042450N2
• Lead Sponsor: Abidi pharmacy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 26 August 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Heart Failure Preserved Ejection Fraction : HF symptom NYHA Class 2 or 3 and Ejection Fraction=50 by Echocardiography and BNP ( B type Natriuretic Peptide) >100 pg/mL within 2 month prior to enrollment
The ability to walk more than 50 meters
No significant changes in diuretic dosage (doubling dose or new prescription) within 1 week prior to enrollment

Exclusion Criteria

Poor echocardiography finding
History of cancer within 3 years prior to enrollment
Uncontrolled hypothyroidism (TSH>4.5) or Hyperthyroidism (TSH<0.4)
Sever hepatic failure (Liver enzyme >3 ULN)
History of taking Pioglitazone within 8 weeks prior to enrollment
Myocardial infraction, unstable angina, percutaneous coronary intervention, or coronary bypass surgery within 60 days prior to enrollment
Decompensated heart failure within 4 weeks prior to enrollment
??An estimated glomerular filtration rate (eGFR) of at least 30 ml per minute per 1.73 m2 body- surface area, according to CKD-EPI formula.
Pregnancy and/or lactation
History of alcohol and other substance abuse
Active or recent (within 2 weeks prior to enrollment) genitourinary infection
Don't have compliance to taking medicine
History of including in another study within 3 month prior to enrollment
Start Angiotensin-Converting Enzyme (ACE) inhibitors, Hydralazine, long-acting nitrates, beta blockers ?? Angiotensin Receptor Blockers (ARBs) within 1 month prior to enrollment
History of allergy with Empagliflozin
History of taking Empagliflozin within 12 week prior to enrollment
Active gross hematuria
History of heart or kidney transplant
HF because of restrictive cardiomyopathy, active myocarditis, ,Constrictive Pericarditis, Sever valvular heart stenosis & hypertrophic cardiomyopathy
Uncontrolled Systolic Blood Pressure = 180 mmHg in two outpatient visit
Symptomatic hypotension or SBP < 100 mmHg
In type 2 diabetes patients who have been treated with at least one blood glucose lowering agent (oral, non-insulin) with any dosage change, within 12 weeks prior to enrollment
In type 2 diabetes patients daily dose of insulin would be changed exceed 10% of the base dose within 3 months before screening
7.5% > HbA1c >9.5% within 3 months before screening in type 2 diabetes patients

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The ratio of mitral peak velocity of early filling (E) to early diastolic mitral annular velocity (E') (E/E' ratio)'Changes. Timepoint: Week 0_ 12_ 26. Method of measurement: Echocardiography.