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Investigating the effects of rosuvastatin in the acute cardiomyopathy induced anthracycline in cancer patients under chemotherapy

Protocol summary

Summary
Objectives: This study aimed to assess the effectiveness of rosuvastatin in reducing the acute cardiomyopathy in the patients undergoing chemotherapy with anthracycline. Design: Randomized, clinical, single-blind, placebo-controlled, single-center, third-phase trial Main inclusion criteria: Cancerous patients undergoing treatment with anthracycline (doxorubicin) in Baghban Special Clinic in April 2016 to April 2017 include. Main exclusion criteria: Patients with history of myocardial infarction; coronary artery disease; patients in the early stages of chemotherapy or radiotherapy; acute restraint or dilated cardiomyopathy; mitral and aortic valvular diseases in initial echocardiography Sample size was calculate 100 people. Method: Patients will randomly located in control group (not receiving rosuvastatin) and rosuvastatin group (receiving rosuvastatin). Studied interventions: In rosuvastatin, 20 mg rosuvastatin use per day before camotherapy up to 6 months. The control group also uses the placebo. The placebo has a similar dose to rosuvastatin (20 mg per day). Main outcome variables: Diastolic and systolic diameter and volume, and ejection fraction of left ventricular and mitral inflow with Doppler pulse (E, A, wave, E/A wave, E-wave deceleration time), and pulmonary venous flow, and Doppler tissue, mitral annulus, E/é ratio are calculated.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016121213090N3
Registration date: 2017-05-08, 1396/02/18
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-05-08, 1396/02/18
Registrant information
Name
Maryam Nabati
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1222 4002
Email address
m.nabati@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University Of Medical Sciences
Expected recruitment start date
2017-01-20, 1395/11/01
Expected recruitment end date
2018-04-05, 1397/01/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effects of rosuvastatin in the acute cardiomyopathy induced anthracycline in cancer patients under chemotherapy
Public title
A clinical trial to investigate the efficiency of rosuvastatin in acute cardiomyopathy induced anthracycline
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Cancerous patients undergoing treatment with anthracycline Exclusion criteria: Patients with history of myocardial infarction; coronary artery disease; patients in the early stages of chemotherapy or radiotherapy; acute restraint or dilated cardiomyopathy; mitral and aortic valvular diseases in initial echocardiography; patients with a history or any symptoms associated with heart failure; hypersensivity to rosuvastatin; active liver diseases; and impaired liver tests; pregnant and lactating women.
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Study randomization method is four blocks.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Deputy of Research Mazandaran University Of Medical Sciences, Moalem Square, Sari, Iran
City
Sari
Postal code
Approval date
2016-12-21, 1395/10/01
Ethics committee reference number
IR.MAZUMS.REC.95.2211

Health conditions studied

1

Description of health condition studied
Cardiomyopathy
ICD-10 code
I42
ICD-10 code description
Cardiomyopathy

Primary outcomes

1

Description
triglycerides level
Timepoint
0 and 6 month
Method of measurement
mg/dl

Secondary outcomes

1

Description
left ventricle ejection fraction
Timepoint
percent
Method of measurement
echocardiography

Intervention groups

1

Description
Intervention group: Rosuvastatin, 20 mg oral pill (by Fanda Pharmaceutical Co.) per day for six months
Category
Treatment - Drugs

2

Description
Control group: placebo, 20 mg oral pill (by School of Pharmacy, Mazandaran University of Medical Sciences) per day for six months
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Fatemeh Zahra Hospital Of Sari
Full name of responsible person
Jamil Esmailian
Street address
Sari Training Building, Fatemeh Zahra Hospital, Artesh Blvd, Sari, Iran
City
Sari

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Mazandaran University of Medical Sciences
Full name of responsible person
Ahmad Ali Enayati
Street address
University of Medical Sciences, Valiasr Highway, Juibar Crossroad, Imam Square, Sari, Iran
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Mazandaran University of Medical Sciences
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
Student Research Committee, Mazandaran University Of Medical Sciences
Full name of responsible person
Jamil Esmailian
Position
Residency Of Cardiology
Other areas of specialty/work
Street address
Building Research Council of Mazandaran University Of Medical Sciences, Moalem Square, Sari, Iran
City
Sari
Postal code
Phone
+98 11 3322 1755
Fax
Email
Jamil.Esmailian@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University Of Medical Sciences
Full name of responsible person
Maryam Nabati
Position
Assistant Professor Of Cardiology
Other areas of specialty/work
Street address
Education department, Fateme Zahra Hospital, Artesh Boulevard, Sari. Iran
City
Sari
Postal code
Phone
+98 11 3304 4866
Fax
Email
dr.mr.nabati@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Student Research Committee, Mazandaran University of Medical Sciences
Full name of responsible person
Jamil Esmailian
Position
Residency of Cardiology
Other areas of specialty/work
Street address
Sari Training Building, Fatemeh Zahra Hospital, Artesh Blvd, Sari, Iran
City
Sari
Postal code
Phone
00
Fax
Email
Jamil.esmailian@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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