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IRCT20210216050375N1 IRCT 2021-02-27 Mashhad University of Medical Sciences Urolihin A in heart Failure Evaluation of urolithin A efficacy in heart failure patients with reduced ejection fraction 2021-08-23 anticipated 10 Complete https://irct.ir/trial/54352 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Crossover, Purpose: Treatment, Randomization description: Simple randomization with random number tables using www.randomization.com, Blinding description: Participant, clinician and statisticians will be unaware of the assigned treatment. 3 heart failure with reduced ejection fraction. Intervention 1: Intervention group: Patients will receive 250 mg Urolithin A BID for one month. Intervention 2: Control group: placebo pills BID for one month. 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 Based on the results decision will be made in the future
public Milad Iranshahi
Vakil Abad Blvd, school of pharmacy, Mashhad University of Medical Sciences
Mashhad Iran (Islamic Republic of) 9177948954 009831801253 iranshahiml@mums.ac.ir Mashhad University of Medical Sciences scientific Milad Iranshahi
Vakil Abad Blvd
Mashhad Iran (Islamic Republic of) 9177948954 009831801253 iranshahiml@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Male Between the ages 25 to 85 years Left ventricular ejection fraction equal or lower than 40% New York Heart Association functional class equal or greater than II Received standard treatment of heart failure (including Angiotensin-converting enzyme 2 inhibitors or Angiotensin II receptor inhibitors and beta blockers) for at least 2 weeks Signed informed consent 20 years 85 years Male History of myocardial infarction during the 8 past weeks History of any malignant disease Renal failure (eGFR lower than 20 ml/1.73 m2/min) hepatic disorder (aminotransferase > 2x upper limit of normal) Extensive heart surgery or angioplasty during the past 30 days Allergy and/or hypersensitivity to specific drugs or substances related to drug used in this clinical trial uncontrolled high blood pressure (Systolic blood pressure higher than 180 mmHg and diastolic blood pressure higher than 100 mmHg) I50 Heart failure Treatment - Drugs Placebo Intervention group: Patients will receive 250 mg Urolithin A BID for one month. Control group: placebo pills BID for one month Left ventricular ejection fraction. Timepoint: Before and 1 month after intervention. Method of measurement: Echocardiography. N-terminal pro b-type natriuretic peptide (NTproBNP). Timepoint: Before and 1 month after intervention. Method of measurement: Evaluation in serum by using a commercially available kit. NYHA functional class. Timepoint: Before and 1 month after intervention. Method of measurement: Evaluation of symptoms by clinician. Serum cardiac troponin. Timepoint: Before and 1 month after intervention. Method of measurement: Evaluation in serum by using a commercially available kit. Mashhad University of Medical Sciences Approved 2021-02-13 Ethics committee of Mashhad University of Medical Sciences Azadi square, Mashhad University of Medical Sciences Mashhad Razavi Khorasan Iran (Islamic Republic of)