Evaluation of Urolithin A efficacy in alleviating symptoms of heart failure patients with reduced ejection fraction
Design
Placebo controlled, cross-over, randomized, triple-blinded phase 3 clinical trial on 10 participants. Randomization will be done using randomization.com website.
Settings and conduct
The study will be conducted in Specialized Cardiology Clinic. In cross-over study participants will receive 250 mg BID for 1 month. Washout period will be 2 weeks. Participants, clinician and statistician will be unaware of the assigned treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: male, age between 25 and 85 years, Left ventricular ejection fraction (LVEF) equal or lower than 40%, New York Heart Association functional class equal or greater than II
Exclusion criteria: history of myocardial infarction during the 8 past weeks, history of any malignant disease, renal failure, hepatic disorder
Intervention groups
Intervention group: In cross-over study participants will receive 250 mg BID for 1 month. Washout period will be 2 weeks.
Control group: Participants will receive placebo tablets with similar appearance to intervention group. Tablets contain FDA accepted excipients.
Main outcome variables
LVEF
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210216050375N1
Registration date:2021-02-27, 1399/12/09
Registration timing:prospective
Last update:2021-02-27, 1399/12/09
Update count:0
Registration date
2021-02-27, 1399/12/09
Registrant information
Name
Milad Iranshahy
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3180 1253
Email address
iranshahiml@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-23, 1400/06/01
Expected recruitment end date
2022-03-20, 1400/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of urolithin A efficacy in heart failure patients with reduced ejection fraction
Public title
Urolihin A in heart Failure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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)
Age
From 20 years old to 85 years old
Gender
Male
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
10
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization with random number tables using www.randomization.com
Blinding (investigator's opinion)
Triple blinded
Blinding description
Participant, clinician and statisticians will be unaware of the assigned treatment
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Azadi square, Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948954
Approval date
2021-02-13, 1399/11/25
Ethics committee reference number
IR.MUMS.REC.1399.629
Health conditions studied
1
Description of health condition studied
heart failure with reduced ejection fraction
ICD-10 code
I50
ICD-10 code description
Heart failure
Primary outcomes
1
Description
Left ventricular ejection fraction
Timepoint
Before and 1 month after intervention
Method of measurement
Echocardiography
Secondary outcomes
1
Description
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
2
Description
NYHA functional class
Timepoint
Before and 1 month after intervention
Method of measurement
Evaluation of symptoms by clinician
3
Description
serum cardiac troponin
Timepoint
Before and 1 month after intervention
Method of measurement
Evaluation in serum by using a commercially available kit
Intervention groups
1
Description
Intervention group: Patients will receive 250 mg Urolithin A BID for one month.
Category
Treatment - Drugs
2
Description
Control group: placebo pills BID for one month
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Parsian clinic
Full name of responsible person
Mohammad Ali Ansari
Street address
West Razi Ave, Imam Reza Square
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١۶
Phone
+98 51 3853 9960
Email
amir_saheb2000@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
ِDaneshgah Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3854 1538
Email
tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Milad Iranshahi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Vakil Abad Blvd, school of pharmacy, Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948954
Phone
009831801253
Email
iranshahiml@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Milad Iranshahi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Vakil Abad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948954
Phone
009831801253
Email
iranshahiml@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Milad Iranshahi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Vakil Abad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948954
Phone
009831801253
Email
iranshahiml@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available