Additional Testosterone treatment in heart failure.
Not Applicable
- Conditions
- Health Condition 1: I508- Other heart failure
- Registration Number
- CTRI/2021/01/030292
- Lead Sponsor
- AIIMS Rishikesh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Male participants , >60 year age, in inpatient and outpatients, who have chronic stable heart failure irrespective of underlying etiology and whose treatment has not been modified in past 4 weeks.
Chronic stable heart failure with NYHA class II or III
Testosterone treatment naive patients
Patients willing to provide written informed consent
Exclusion Criteria
Any contraindication to testosterone therapy
Deranged Prostate specific antigen
Deranged liver function
Deranged renal function (serum creatinine > 1.5mg/dl)
Malignancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in functional capacity assessment by 6 minutes walk test <br/ ><br>Change in Frailty assessment by using FRIED criteria of Frailty Phenotype <br/ ><br>Change in quality of life assessment using kansas city cardiomyopathy questionnaireTimepoint: 12 weeks
- Secondary Outcome Measures
Name Time Method Status of cardiac remodeling by echocardiography in the form of improved ejection fraction as a prognostic marker for disease progression <br/ ><br>Change in status of BNP level as a surrogate marker <br/ ><br>Adverse drug reaction related to testosterone transdermal patchTimepoint: 12 weeks