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Evaluation of Testosterone therapy in Heart Failure

Beneficial effects of Testosterone therapy on functional capacity, cardiovascular parameters, and quality of life in patients with Congestive Heart Failure

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2013070113828N1
Enrollment
50
Registered
2013-10-20
Start date
2013-09-14
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congestive Heart Failure. I50.0

Interventions

Intervention 1: 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. Intervention
Treatment - Drugs
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.
Placebo group:Patients with heart failure who undergo saline injection(1ml)each 4 weeks each 4 weeks up to 12 weeks

Sponsors

Islamic Azad University, Najafabad Branch
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
50 Years to 80 Years

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
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.;Quality Of Llife. Timepoint: Before intervention and also at endpoint after 12 weeks. Method of measurement: Quality Of Llife Questionnaire.;Depression status. Timepoint: Before intervention and also at endpoint after 12 weeks. Method of measurement: Beck Questionnaire.;Changes in body weight. Timepoint: Baseline and also at the end of each month. Method of measurement: Weight scale.;Muscle strength. Timepoint: Baseline and also at the end of each month. Method of measurement: Hand Dynamometer.;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

MeasureTime frame
PSA measure. Timepoint: Before intervention and also as endpoint after 12 weeks. Method of measurement: ELISA Method.

Countries

Iran (Islamic Republic of)

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026