Protocol summary

Summary
This study is a sequential single blind randomized trial on 18-70 years age, new diagnosed cancer patients that should undergo antracyclin therapy. Written informed consent are obtained from all patients. Before initiation of chemotherapy, all patients undergo echocardiography by Vivid S5 and the images are stored for off line analysis. Left ventricular end diastole and end systole diameters are measured and LVEF is calculated by Simpson method. Evaluation for diastolic function is performed by mitral inflow evaluation: pulse doppler (E,A wave, E/A ratio, E wave deceleration time), pulmonary veins flow and tissue doppler of mitral valve annulus. E/e' ratio is calculated for determination of filling pressure. Patients are inserted randomly in control(no carvedilol)and intervention(carvedilol)groups. Age,sex and other variables are similar in two groups. In the intervention group, carvedilol is initiated at least 24 hours before first cycle of chemotherapy. Initial dose is 3.12mg BID( in patients with systolic blood pressure more than 90-100mmHg). Dose is gradually increased after one week. If systolic blood pressure is more than 90 mmHg , maximum dose is increased to 6.25mg BID. Patients in intervention group are evaluated for hypotension, bradycardia and etc. If hypotension occurs, carvedilol is decreased or stopped. If systolic blood pressure increased, it is again initiated. All patients receive chemotherapy according to protocol.One month later,cardiac Troponin I is measured. Then, in the terminal part of follow up, after 6months, patients undergo echocardiography that echocardiographer is blinded. Two groups are compared for change in left ventricular systolic and diastolic performance and Troponin levels.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014121213090N2
Registration date: 2015-01-09, 1393/10/19
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-01-09, 1393/10/19
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
2015-01-30, 1393/11/10
Expected recruitment end date
2016-01-30, 1394/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficiency of carvedilol in the protection of Anthracycline-induced cardiomyophy in cancer patients undergoing chemotheraphy compared with control group
Public title
Efficiency of carvedilol in the protection of Anthracycline-induced cardiomyophy in cancer patients undergoing chemotheraphy compared with control group
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Cancer patients; 18-70 years old; newly diagnosed; candidate for antracyclin therapy. Exclusion criteria: history of myocardial infarction; coronary artery disease; LVEF<50%; significant valvular heart disease; history of congestive heart failure; sinus bradycardia, complete heart block, systolic blood pressure less than 90 mmHg.
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
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
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Mazandaran University of Medical Sciences Ethics Committee
Street address
Mazandaran University of Medical Sciences
City
Sari
Postal code
Approval date
2014-11-19, 1393/08/28
Ethics committee reference number
28 8 2014

Health conditions studied

1

Description of health condition studied
Cancer
ICD-10 code
C00-C97
ICD-10 code description
Malignant Neoplasms

Primary outcomes

1

Description
Cardiomyopathy
Timepoint
Before treatment,6 months later
Method of measurement
Echocardiography

Secondary outcomes

1

Description
Level of cardiac Troponin-I
Timepoint
One month after treatment
Method of measurement
Venopuncture

Intervention groups

1

Description
In case group,at least 24 hours before chemotherapy,carvedilol 3.12- 6.25mg BID is initiated and continued till termination of chemotherapy.
Category
Treatment - Drugs

2

Description
Control group receive chemotherapy drug alone.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Toba clinic
Full name of responsible person
Maryam Nabati
Street address
Khazar square
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
Dr Ahmadali Enayati
Street address
Moallem square
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
Mazandaran University of Medical Sciences
Full name of responsible person
Maryam Nabati
Position
Cardiologist, Fellowship of Echocardiography
Other areas of specialty/work
Street address
Fateme Zahra Hospital, Shahrdari Square
City
Sari
Postal code
Phone
+98 11 3332 4002
Fax
Email
dr.mr.nabati@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
Cardiologist, Fellowship of Echocardiography
Other areas of specialty/work
Street address
Fateme Zahra Hospital, Shahrdari Square
City
Sari
Postal code
Phone
+98 11 3332 4002
Fax
Email
dr.mr.nabati@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Maryam Nabati
Position
Cardiologist, Fellowship of Echocardiography
Other areas of specialty/work
Street address
Fatemeh Zahra Hospital
City
Sari
Postal code
48188-13771
Phone
+98 11 3332 4002
Fax
+98 11 3332 4002
Email
Dr.mr.nabati@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
Loading...