]>
IRCT20190122042450N2 IRCT 2019-05-20 Abidi pharmacy ٍEffect of Empagliflozin in ِheart failure preserved ejection fraction Effect of Empagliflozin on diastolic function and renal dynamics and biochemical parameters in people with heart failure with preserved ejection fraction 2019-06-21 anticipated 200 Complete https://irct.ir/trial/38874 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 4 block randomization: Each lables has one letter A or B. Randomization sequence will be created using www.sealedenvelope.com using random block sizes of 4 based on treatment group A or B for 200 patients, Blinding description: In this trial we use Empagliflozin and placebo with same package ,color and shape with different cod combination number (based on table of random numbers ) and letters A & B. After enrollment , one code is assigned to each patient , which will be recognized by this code until the end of this study. Participants, Principle Investigator,Cardiologist, , laboratory technician, outcome assessor & data analyser, all of them are blind because they don't know this cod is Empagliflozin or placebo. 3 Heart Failure preserved Ejection Fraction. 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. Abidi pharmacy. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Mohammad Ebrahim Khamseh
Behafarin ST, KarimkhanAVE, Vali-asr Sq, Tehran, Iran
Tehran Iran (Islamic Republic of) 1593748711 +98 21 8894 5246 khamseh.m@iums.ac.ir Iran University of Medical Sciences scientific Mohammad Ebrahim Khamseh
Behafarin ST, Karimkhan AVE, Vali-asr Sq, Tehran, Iran
Tehran Iran (Islamic Republic of) 1593747811 +98 21 8894 5246 khamseh.m@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) 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 40 years 80 years Both 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 یا 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 I50.1 Left ventricular failure Treatment - Drugs Placebo Intervention group: Tablet Empagliflozin 10 milligram daily over 6 months produced by Dr. Abidi pharmacy Control group: placebo, daily over 6 months produced by Dr. Abidi pharmacy 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. 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: Question. Duration of admission. Timepoint: Randomization through each subject's last visit, up to a maximum of 26 weeks per subject. Method of measurement: Question. Measured Quality of Life. Timepoint: 0_26 Week. Method of measurement: Filling Short Form-36،MLHF، NYHA. Anthropometric findings. Timepoint: 0_12_26 Week. Method of measurement: Scale and Meter. Mean Diuretic dosage taking. Timepoint: 0_12_26 Week. Method of measurement: Question. Mean spirometry findings. Timepoint: 0_26 Week. Method of measurement: اسپیرومتری. Incidence of acute renal failure (AKI). Timepoint: Randomization through each subject's last visit, up to a maximum of 26 weeks per subject. Method of measurement: Observe BUN & Cr during study. Hypoglycemia. Timepoint: Randomization through each subject's last visit, up to a maximum of 26 weeks per subject. Method of measurement: Question and BS chart. Hyperkalemia. Timepoint: 0_12_26 week. Method of measurement: Lab test. Changes in the albuminuria. Timepoint: 0_12_26 week. Method of measurement: Lab test. Urinary tract/genital infection. Timepoint: Randomization through each subject's last visit, up to a maximum of 26 weeks per subject. Method of measurement: Question. Diabetes ketoacidosis. Timepoint: Randomization through each subject's last visit, up to a maximum of 26 weeks per subject. Method of measurement: See hospitalization records. Foot ulcer/Amputation. Timepoint: Randomization through each subject's last visit, up to a maximum of 26 weeks per subject. Method of measurement: Question. High sensitivity C reactive protein (mg/L), Interleukin1، troponin I، N terminal pro-BNP (pg/mL) levels. Timepoint: 0 , 26 Week. Method of measurement: Lab test. Abidi pharmacy Approved 2019-02-24 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran Tehran Tehran Iran (Islamic Republic of)