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Additional Testosterone treatment in heart failure.

Adjuvant testosterone therapy in chronic heart failure - A Randomized Open Label Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/01/030292
Enrollment
160
Registered
2021-01-06
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: I508- Other heart failure

Interventions

Intervention1: Testosterone: 5mg testosterone gel+recommended standard therapy for chronic stable heart failure Duration 12 week Route - Transdermal Control Intervention1: Recommended standard therapy

Sponsors

AIIMS Rishikesh
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: Any contraindication to testosterone therapy Deranged Prostate specific antigen Deranged liver function Deranged renal function (serum creatinine > 1.5mg/dl) Malignancy

Design outcomes

Primary

MeasureTime frame
Change in functional capacity assessment by 6 minutes walk test Change in Frailty assessment by using FRIED criteria of Frailty Phenotype Change in quality of life assessment using kansas city cardiomyopathy questionnaireTimepoint: 12 weeks

Secondary

MeasureTime frame
Status of cardiac remodeling by echocardiography in the form of improved ejection fraction as a prognostic marker for disease progression Change in status of BNP level as a surrogate marker Adverse drug reaction related to testosterone transdermal patchTimepoint: 12 weeks

Countries

India

Contacts

Public ContactDr Minakshi Dhar

AIIMS Rishikesh

minakshi.dhar@rediffmail.com7060002778

Outcome results

None listed

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