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Adjuvant testosterone therapy in chronic heart failure (ATTIC): a randomised open-label trial
Minakshi Dhar1, Kartik Mittal2, Ashwin Parchani2
1Internal Medicine, All India Institute of Medical Sciences-Rishikesh, Rishikesh, Uttarakhand, India minakshi.dhar@rediffmail.com.
Insights
Testosterone therapy shows promise for improving heart failure symptoms and functional capacity in older men. This randomized controlled trial investigates its efficacy and safety in geriatric patients with chronic stable heart failure.
Area of Science:
- Cardiology
- Geriatrics
- Endocrinology
Background:
- Heart failure significantly impacts morbidity and mortality in the elderly.
- Current therapies offer limited benefits for geriatric heart failure patients.
- Testosterone therapy is an emerging treatment with potential benefits for cardiac function.
Purpose of the Study:
- To evaluate the efficacy of testosterone gel as an adjunct therapy for chronic stable heart failure in men over 60.
- To assess the impact of testosterone therapy on functional capacity, frailty, and quality of life.
- To determine the effects on cardiac remodeling and relevant biomarkers.
Main Methods:
- An open-label, randomized controlled trial involving 986 adult males aged 60+ with chronic stable heart failure.
- Participants received standard heart failure treatment, with the intervention group receiving additional testosterone gel.
- Assessments of functional capacity, frailty, quality of life, echocardiography, and N-terminal pro-B-type natriuretic peptide (NT-proBNP) were conducted at baseline and 12 weeks.
Main Results:
- Primary endpoints focus on changes in the 6-minute walk test, frailty index, and quality of life at 3 months.
- Secondary endpoints include changes in cardiac remodeling via echocardiography and NT-proBNP levels.
- Adverse drug reactions will also be monitored throughout the study.
Conclusions:
- Testosterone therapy presents a potential low-cost therapeutic option for improving outcomes in elderly heart failure patients.
- Further research is warranted to confirm the long-term benefits and safety profile.
- This trial aims to provide robust data on testosterone's role in managing geriatric heart failure.
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, among others.
Methods:
We have planned an open-label, parallel design, 1:1 randomised controlled trial, which aims to recruit 986 adult males above the age of 60 diagnosed with chronic stable heart failure fulfilling the eligibility criteria. The participants will be randomised into 2 groups of 493 each. Both groups will receive standard recommended treatment regimen 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 differences in functional capacity, frailty and quality of life at 3 months compared with 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 23 software. Primary objectives of change in 6-minute walk test, frailty index and quality of life will be analysed using the student's 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 November 2020. This study involves human participants and was approved by institutional ethical committee, DHR Reg: EC/NEW/Inst/2020/1046CDSCO, Reg No: ECR/736/Inst/UK/2015/RR-18. Participants gave informed consent to participate in the study before taking part.
Trial Registration Number:
(CTRI)-REF/2020/12/030292.
