Heart Failure preserved Ejection Fraction. Left ventricular failure
Conditions
Interventions
Intervention 1: Intervention group: Tablet Empagliflozin 10 milligram daily over 6 months produced by Dr. Abidi pharmacy. Intervention 2: Control group: placebo, daily over 6 months produced by Dr.
Sponsors
Abidi pharmacy
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Inclusion criteria
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
Exclusion criteria: Poor echocardiography finding History of cancer within 3 years prior to enrollment Uncontrolled hypothyroidism (TSH>4.5) or Hyperthyroidism (TSH3 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 HbA1c >9.5% within 3 months before screening in type 2 diabetes patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Hospilization due to heart failure. Timepoint: Time Frame: Randomization through each subject's last visit, up to a maximum of 26 weeks per subject. Method of measurement: Question.;Mortality due to heart failure. Timepoint: Randomization through each subject's last visit, up to a maximum of 26 weeks per subject. Method of measurement: Evaluate during follow up.;Change mean blood pressure in setting position. Timepoint: 0_12_26 Week. Method of measurement: Question.;? Change mean peak VO2 ("V" for volume, "O2" for oxygen) (mL/kg/min). Timepoint: 0_12_26 Week. Method of measurement: cardiopulmonary exercise test.;Myocardial oxygen consumption. Timepoint: 0_12_26 Week. Method of measurement: SBP* HR.;Six minutes’ walking distance. Timepoint: 0_12_26 Week. Method of measurement: six minutes’ walking test.;Mortality due to renal failure. Timepoint: Time Frame: Randomization through each subject's last visit, up to a maximum of 26 weeks per subject. Method of measurement: evaluate during follow up.;Hospitalization due to renal failure. Timepoint: Randomization through each subject's last visit, up to a maximum of 26 weeks per subject. Method of measurement: Question.;Assessment of renal function over time. Timepoint: 0_12_26 Weeks. Method of measurement: Glomerular Filtration Rate (GFR) equation with CKD-EPI.;Renal replacement therapy. Timepoint: Randomization through each subject's last visit, up to a maximum of 26 weeks per subject. Method of measurement: Question.;Progression of albuminuria. Timepoint: 0_12_26 Week. Method of measurement: urinary albumin to creatinine ratio.;All-cause Mortality. Timepoint: Randomization through each subject's last visit, up to a maximum of 26 weeks per subject. Method of measurement: Evaluate during follow up.;Total Hospitalizations (Including Repeat Hospitalizations) for the Management of Heart Failure. Timepoint: Randomization through each subject's last visit, up to a maximum of 26 weeks per subject. Method of measurement: Questi | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMohammad Ebrahim Khamseh
Iran University of Medical Sciences
Outcome results
None listed