Investigating the effect of nandrolone on the quality of life in female patients with heart failure
Design
A single-blinded clinical trial with parallel groups and phase 3 that will be conducted on 90 patients. Patients will be assigned to one of the intervention or placebo groups using the block randomization method using the generated -computer numbers by the Random Allocation software.
Settings and conduct
This study will be conducted on women with heart failure referred to Tabriz Shahid Madani Hospital .The study will be conducted as a single-blind clinical trial. The patient will be blind about her allocation to the intervention or placebo group. The Syringes of drug and placebo will be similar in shape, size and color.
Participants/Inclusion and exclusion criteria
In this study, women over 50 years old with FCII and FCIII heart failure will be included. Patients with the occurrence of ischemia in the last 6 months of the disease, hormonal disorders, hypertension and OCP use will not be included in the study.
Intervention groups
Patients in the intervention group will receive nandrolone decanoate 25 mg intramuscularly once a week for one month, and in the placebo group, 25 mg vials of isotonic solution will be provided by Caspian Pharmaceutical Company.
Main outcome variables
Quality of Life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231116060079N1
Registration date:2023-12-30, 1402/10/09
Registration timing:prospective
Last update:2023-12-30, 1402/10/09
Update count:0
Registration date
2023-12-30, 1402/10/09
Registrant information
Name
Mohammadreza Taban
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3337 3919
Email address
taban@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-21, 1402/11/01
Expected recruitment end date
2024-04-19, 1403/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of nandrolone on the quality of life in female patients with heart failure
Public title
Investigating the effect of nandrolone on the quality of life
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Women with heart failure FCII and FCIII
Ejection Fraction less than and equal to 40
Age over 50 years
Exclusion criteria:
Occurrence of ischemia in the last 6 months of the disease
Hormonal disorders
Consumption of oral contraceptive pill (OCP)
Hypertension
Age
From 50 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly with Block randomization assigned to one of the intervention or placebo groups using computer-generated numbers produced by the Random allocation software. Thus, in this software, the number of groups and the total sample size will be entered, and then the "randomization” will be implemented in the block section. Then, the computer-generated number list will be given to the physician, and the physician will assign patients to groups according to the determined order by the software for entry into one of the groups. Thus, the randomization process will continue until the final sample size is reached.
Blinding (investigator's opinion)
Single blinded
Blinding description
The study will be conducted as a single-blind clinical trial. The patient will be blind about her allocation to the intervention or placebo group. The Syringes of drug and placebo will be similar in shape, size and color.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences., 29 Bahman Blvd., Tabriz., Iran.
City
Tabriz
Province
East Azarbaijan
Postal code
5166616441
Approval date
2023-10-02, 1402/07/10
Ethics committee reference number
IR.TBZMED.REC.1402.489
Health conditions studied
1
Description of health condition studied
Heart failure
ICD-10 code
I50
ICD-10 code description
Heart failure
Primary outcomes
1
Description
Quality of Life
Timepoint
Before and six weeks after the intervention
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Cardiac ejection fraction
Timepoint
Before and six weeks after the intervention
Method of measurement
Eco-cardiography
Intervention groups
1
Description
Intervention group: Patients in the intervention group will receive nandrolone decanoate 25 mg intramuscularly once a week for one month that will be provided by Caspian Pharmaceutical Company.
Category
Treatment - Other
2
Description
Control group: Patients in the placebo group will receive 25 mg vials of isotonic solution will be provided by Caspian Pharmaceutical Company.