Beneficial effects of Testosterone therapy on functional capacity, cardiovascular parameters, and quality of life in patients with Congestive Heart Failure
Methods: A total of 50 male patients who suffered from congestive heart failure were recruited in a double-blind, placebo-controlled trial and randomized to receive an intramuscular (gluteal) long-acting androgen injection (1 mL of testosterone enatated 250mg/ml) once every four weeks for 12 weeks or receive intramuscular injections of saline (1 mL of 0.9% wt/vol NaCl) with the same protocol. Measurements to the study including assessment of cardiovascular parameters, quality of life and depression status were performed before intervention and also as endpoint after 12 weeks. Also, the changes in body weight, muscle strength, 6-min walk distance (6MWD), functional capacity as well as hemodynamic indicators were assessed at baseline and also at the end of each month in both groups and compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013070113828N1
Registration date:2013-10-20, 1392/07/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-10-20, 1392/07/28
Registrant information
Name
Ahmad Mirdamadi
Name of organization / entity
Islamic Azad university ,Najafabad branch
Country
Iran (Islamic Republic of)
Phone
+98 31 1223 8028
Email address
drsamirdamadi@pmd.iaun.ac.ir
Recruitment status
Recruitment complete
Funding source
Islamic Azad University, Najafabad Branch
Expected recruitment start date
2013-09-14, 1392/06/23
Expected recruitment end date
2014-03-14, 1392/12/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Beneficial effects of Testosterone therapy on functional capacity, cardiovascular parameters, and quality of life in patients with Congestive Heart Failure
Public title
Evaluation of Testosterone therapy in Heart Failure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria were: 1 -Male Gender and age 50-80 with 2 - Heart Failure approved by Echocardiography and 6MWT test 3 -Having clinically stable heart condition in the last three months and not hospitalized for heart failure problems 4 - Classes II and III are classified as being in NYHA 5 - Ejection fraction(EF) less than 40 percent 6 - No signs of unstable angina and myocardial infarction in recent months 7 - Absence of severe liver and pulmonary disease 8 -Absence of uncontrolled hypertension 9 - No erytrocytosis (hematocrit ≥ 50%) 10 - No history of breast and prostate cancer and no history of prostate nodules, 11 - Absence of lower urinary tract symptoms and severe BPH disease and high levels of PSA 12 -Consent patients into the study.
Exclusion criteria were: 1 - Cancel patient continued therapy 2 -Patient not continue more than a month after the injection,3 - oversensitivity to drug and important side effects - 4 patients died during the study.
Age
From 50 years old to 80 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Isfahan University Of Medical Sciences
Street address
Isfahan University, Azadi Square, Isfahan
City
Isfahan
Postal code
Approval date
2013-09-12, 1392/06/21
Ethics committee reference number
12/پ/4/م/182
Health conditions studied
1
Description of health condition studied
Congestive Heart Failure
ICD-10 code
I50
ICD-10 code description
I50.0
Primary outcomes
1
Description
Assessment of Cardiovascular parameter like Ejection Fraction/Diastolic function and Left Ventricular Dimentions at the end of Systole and Diastole
Timepoint
Before intervention and also as endpoint after 12 weeks
Method of measurement
Echocardiography
2
Description
Quality Of Llife
Timepoint
Before intervention and also at endpoint after 12 weeks
Method of measurement
Quality Of Llife Questionnaire
3
Description
Depression status
Timepoint
Before intervention and also at endpoint after 12 weeks
Method of measurement
Beck Questionnaire
4
Description
Changes in body weight
Timepoint
Baseline and also at the end of each month
Method of measurement
Weight scale
5
Description
Muscle strength
Timepoint
Baseline and also at the end of each month
Method of measurement
Hand Dynamometer
6
Description
6-Minute Walk Distance (6MWD)
Timepoint
Baseline and also at the end of each month
Method of measurement
Measurment of distance that patients had walked within 6 minute in hospital coridour
Secondary outcomes
1
Description
PSA measure
Timepoint
Before intervention and also as endpoint after 12 weeks
Method of measurement
ELISA Method
Intervention groups
1
Description
Case group:Patients with Heart Failure who undergo intramuscular injection of long acting testosterone(1 mL of testosterone enatated 250mg/ml)each 4 weeks up to 12 weeks.
Category
Treatment - Drugs
2
Description
Placebo group:Patients with heart failure who undergo saline injection(1ml)each 4 weeks each 4 weeks up to 12 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfafan Hospital
Full name of responsible person
Dr.Mirdamadi
Street address
Sheikhbahaei Street, Isfahan
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University, Najafabad Branch
Full name of responsible person
Dr.Mirdamadi
Street address
Najafabad, Isfahan
City
Najafabad
Grant name
Grant code / Reference number
Nothing
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University, Najafabad Branch
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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University, Najafabad Branch
Full name of responsible person
Dr.Mirdamadi
Position
Cardiologist,Fellowship of Echocardiography/Assistant professor of medical school
Other areas of specialty/work
Street address
Sheikhbahaei Street, Isfahan Hospital,
City
Isfahan
Postal code
Phone
+98 31 1233 0015
Fax
+98 31 1223 8028
Email
drsamirdamadi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University, Najafabad Branch
Full name of responsible person
Dr.Mirdamadi
Position
Cardiologist,Fellowship of Echocardiography/Assistant professor of medical school
Other areas of specialty/work
Street address
Sheikhbahaei Street, Isfahan Hospital,
City
Isfahan
Postal code
Phone
+98 31 1233 0015
Fax
+98 31 1223 8028
Email
drsamirdamadi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)