Adjuvant Testosterone Therapy in Chronic Heart Failure (ATTIC) – A Randomised Open-Label Trial

ABSTRACT Introduction Heart failure is a major contributor to morbidity and mortality in the geriatric population, with no promising therapy currently available with considerable benefit. Testosterone therapy is an emerging viable treatment option given its beneficial effects, including improving cardiac functional capacity, alleviating symptoms, and low cost, amongst others. Methods We have planned an open-label, parallel design, 1:1 randomized controlled trial which aims to recruit 160 adult males above the age of 60 diagnosed with chronic stable heart failure fulfilling the eligibility criteria. The participants will be randomized into two groups of 80 each. Both groups will receive standard recommended treatment regime of chronic stable heart failure and intervention arm participants will receive additional testosterone gel. All participants will be assessed at baseline, 4 weeks, 6 weeks and 12 weeks. The primary endpoints will assess the difference in functional capacity, frailty and quality of life at 3 months compared to baseline. The secondary endpoints will include the mean change from baseline at 3 months in cardiac remodelling using echocardiography, serum brain natriuretic peptide levels, the incidence of adverse drug reaction. Statistical Analysis The data will be analysed with the help of SPSS software. Primary objectives of change in 6MWT, Frailty index and quality of life will be analysed using the student t-test. The statistical significance will be defined as p-value <0.05 and taking confidence level as 95%. Ethical clearance Institutional Ethics Committee clearance taken via letter no AIIMS/IEC/20/847, dated 21/11/2020