The study of the safety and effect of high dose allopurinol on the clinical, laboratory and echocardiographic variables in patients with severe left ventricle systolic dysfunction
The aim of the study is to evaluate the safety and effect of high dose allopurinol on the clinical, laboratory and echocardiographic variables in patients with severe left ventricle systolic dysfunction.
In this clinical trial study 30 patients referring to Rajaie cardiovascular medical and research center heart failure clinics from 18 to 80 years old who had severe heart failure and New York heart association functional class II-III and had informed consent for participating in the study were included. Patients must have had a complete optimal treatment for at least one month before entrance into the study. The diagnosis of severe left ventricular systolic dysfunction is according to the echocardiography done by a single echocardiologist and is defined as Left ventricle ejection fraction of less than 35%. The exclusion criteria are glomerular filtration rate of less than 60ml/min, gout, severe liver failure, patients without informed consent or those that have had sensitivity to allopurinol.
Allopurinol is started with the dose of 600 mg daily in patients not taking it and increased to this dose in patients taking the medicine from before. The patients are observed for 3 three months. They have initial echocardiographic evaluation, strain imaging, laboratory testing and 6 minute walk test. And after 3 months they again have complete echocardiographic evaluation, strain imaging, laboratory testing and 6 minute walk test. The main adverse effects that will be noted are skin rashes and gasterointestinal problems.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015112125171N1
Registration date:2016-05-23, 1395/03/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-05-23, 1395/03/03
Registrant information
Name
Mohammad Mostafa Ansari Ramandi
Name of organization / entity
Rajaie Cardiovascular Medical and Research Center, Iran University of Medical Sciences, Tehran, Iran
Country
Iran (Islamic Republic of)
Phone
+98 88233597
Email address
naderi@rhc.ac.ir
Recruitment status
Recruitment complete
Funding source
Rajaie cardiovascular medical and research center
Expected recruitment start date
2016-02-28, 1394/12/09
Expected recruitment end date
2016-03-06, 1394/12/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The study of the safety and effect of high dose allopurinol on the clinical, laboratory and echocardiographic variables in patients with severe left ventricle systolic dysfunction
Public title
The study of the safety and effect of high dose allopurinol in patients with severe heart failure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age of 18-80 years old; severe left ventricle systolic dysfunction (Ejection fraction of less than 35%) on optimal medical treatment for at least one month with New York heart association functional class of II-III; having informed written consent.
Exclusion criteria: Below the age of 18 and above the age of 80 years old; glomerular filtration rate of less than 60ml/min; serum creatinine level of more than 3mg/dl; severe hepatic failure; use of azathioprin; use of 6mercaptopurin; use of warfarin; known history of sensitivity to allopurinol.
Age
From 18 years old to 80 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Rajaie Cardiovascular Medical and Research Center, Iran University of Medical Sciences, Tehran, Iran
Street address
Rajaie Cardiovascular Medical and Research Centeق, Tehran, Iran
City
Tehran
Postal code
Approval date
2016-02-27, 1394/12/08
Ethics committee reference number
RHC.AC.IR.REC.1394.35
Health conditions studied
1
Description of health condition studied
Heart failure
ICD-10 code
150
ICD-10 code description
Primary outcomes
1
Description
ProBNP
Timepoint
3 month
Method of measurement
Laboratory kit
2
Description
6 minute walk test
Timepoint
3 month
Method of measurement
Rehabilitation department of the center
3
Description
Strain echocardiography
Timepoint
3 month
Method of measurement
Vivid 6s echocardiography system
4
Description
Quality of life of the patients
Timepoint
3 month
Method of measurement
IHF-QoL
Secondary outcomes
1
Description
Skin rash
Timepoint
during the 3 months
Method of measurement
Medical history and physical exam
2
Description
Gastrointestinal compliations
Timepoint
during the 3 months
Method of measurement
Medical history and physical exam
Intervention groups
1
Description
Using 600 mg allopurinol daily for 3 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rajaie Cardiovascular Medical and Research Center. Tehran, Iran
Full name of responsible person
Mohammad Mostafa Ansari-Ramandi
Street address
Rajaie Cardiovascular Medical and Research Center. Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rajaie Cardiovascular Medical and Research Center, Iran University of Medical Sciences, Tehran, Iran
Full name of responsible person
Majid Maleki
Street address
Rajaie Cardiovascular Medical and Research Center, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rajaie Cardiovascular Medical and Research Center, Iran University of Medical Sciences, Tehran, Iran
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Rajaie Cardiovascular Medical and Research Center. Tehran, Iran
Full name of responsible person
Mohammad Mostafa Ansari-Ramandi
Position
Cardiology resident
Other areas of specialty/work
Street address
Rajaie Cardiovascular Medical and Research Center. Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8823 3597
Fax
Email
dr_mm_ansari@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rajaie Cardiovascular Medical and Research Center, Iran University of Medical Sciences, Tehran, Iran
Full name of responsible person
Nasim Naderi
Position
Cardiologist, heart failure specialist
Other areas of specialty/work
Street address
Rajaie Cardiovascular Medical and Research Centeق, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2392 2115
Fax
Email
dr_mm_ansari@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Rajaie Cardiovascular Medical and Research Center, Iran University of Medical Sciences, Tehran, Iran
Full name of responsible person
Mohammad Mostafa Ansari-Ramandi
Position
Cardiology resident
Other areas of specialty/work
Street address
Rajaie Cardiovascular Medical and Research Center. Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8823 3597
Fax
Email
dr_mm_ansari@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)