Protocol summary

Summary
Patients with heart failure and LVEF less than 35% and NYHA FC II and more will be selected . Primary data including echocardiographic measures and laboratory data including BS, Uric acid , Cr, BUN , CRP , CBC , Total Chl , TG , LDL , HDL , Bil (T and D) , AST , ALT and 6-minute walk test and complete history taking will be taken . Drug history of patients will be scrutinized and will be adjusted so that every patient taking at least the standard 4-drug heart failure regimen at least for 2 weeks . According to inclusion and exclusion criteria patients will be entered to the study and randomly assigned into two groups . Drug and placebo will be started with 25mg single dose at bedtime and gradually increasing upto maximum dosage of 50mg twice daily. Patients will be visited at 2 , 4 , 8 and 12 weeks and monitored for vital signs , probable adverse drug reactions and all the clinical and paraclinical data will be examined again at the end of the survey and collected data will be analyzed . In addition if during the follow up visits , any adverse reaction or intolerance were seen , the patient will quit from the study.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201101045544N1
Registration date: 2011-06-06, 1390/03/16
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-06-06, 1390/03/16
Registrant information
Name
Hossein Navid
Name of organization / entity
Shaheed Rajaee Heart Hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 2200 0946
Email address
dr_hona@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research shahid Rajaee research center
Expected recruitment start date
2011-01-21, 1389/11/01
Expected recruitment end date
2011-05-22, 1390/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Double Blind Randomized Clinical Trial for Evaluation of Sildenafil and placebo effects on improvement of clinical and paraclinical measures on patients with severe Systolic Heart Failure
Public title
Evaluation of Sildenafil and placebo effects on improvement of clinical and paraclinical measures on patients with severe heart failure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : Adult with at least class II CHF ; Able to give Informed consent Exclusion Criteria : Unable to give informed consent ; Currently taking nitrates ; Comorbid condition(s) that could limit walking ; resting SBP<90mmHg
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Medical Ethics Committee of Tehran University of medical science
Street address
Pardis Hemmat branch
City
Tehran
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
4258

Health conditions studied

1

Description of health condition studied
Ischemic cardiomyopathy
ICD-10 code
125.5
ICD-10 code description
Ischaemic cardiomyopathy

2

Description of health condition studied
Dilated cardiomyopathy
ICD-10 code
142.0
ICD-10 code description
Congestive cardiomyopathy

Primary outcomes

1

Description
exertional dyspnea
Timepoint
before trial and then every 2 weeks for one month and monthly thereafter
Method of measurement
NYHA functional class classification

2

Description
6-minute walk test
Timepoint
Before and after trial
Method of measurement
total distance walked

3

Description
Quality of life (QoL)
Timepoint
Before and at the end
Method of measurement
MacNew HRQL Questionnaire- Farsi version

4

Description
Left ventricular ejection fraction(EF)
Timepoint
before and at the end
Method of measurement
Echocardiography with Vivid3 for measuring LVEF by 2D and simpson method.

Secondary outcomes

1

Description
mortality
Timepoint
every 2 week twice then monthly for 3 month.
Method of measurement
Mortality

2

Description
Headache
Timepoint
every 2 week twice then monthly for 3 month.
Method of measurement
Questionnaire

3

Description
Hypotension
Timepoint
every 2 week twice then monthly for 3 month
Method of measurement
BP measurement with mercury sphygmomanometer

4

Description
Priapism
Timepoint
every 2 week twice then monthly for 3 month
Method of measurement
Questionnaire

Intervention groups

1

Description
According to the study design (Randomized and double blinded) ; eligible patients are given by chance drug or placebo with dose of 25mg at bedtime for 1 week and up titrated to 25mg twice daily for the next week . After 2week visit according to the patient`s condition dose will be increased up to 50mg twice daily .
Category
Treatment - Drugs

2

Description
According to the study design (Randomized and double blinded) ; eligible patients are given by chance drug or placebo with dose of 25mg at bedtime for 1 week and up titrated to 25mg twice daily for the next week . After 2week visit according to the patient`s condition dose will be increased up to 50mg twice daily .
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Rajaee Heart center
Full name of responsible person
Hossein Navid
Street address
Valiasr (AJ) st , Niayesh Highway
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research shahid Rajaee research center
Full name of responsible person
Majid Hghjoo M.D
Street address
Shahid Rajaee Hospital , Valiasr st , Niayesh Highway
City
Tehran
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 shahid Rajaee research center
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
Shahid Rjaee Heart Center
Full name of responsible person
Hossein Navid M.D
Position
Resident of cardiology
Other areas of specialty/work
Street address
Valiasr (Aj) , Niayesh Highway
City
Tehran
Postal code
Phone
+98 21 23921
Fax
Email
dr_hona@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Rajaee Heart Center
Full name of responsible person
Ahmad Amin M.D
Position
Associated Professor
Other areas of specialty/work
Street address
Valiasr (AJ) st , Niayesh Highway
City
Tehran
Postal code
Phone
+98 21 2392 2172
Fax
Email
aamin@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Rajaee Heart Center
Full name of responsible person
Hossein Navid M.D
Position
Resident of cardiology
Other areas of specialty/work
Street address
Valiasr (AJ) , Niayesh Highway
City
Tehran
Postal code
Phone
+98 21 23921
Fax
Email
dr_hona@yahoo.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...