Adjuvant testosterone therapy in chronic heart failure (ATTIC): a randomised open-label trial Article Swipe
Minakshi Dhar
,
Kartik Mittal
,
Ashwin Parchani
,
Manu Sharma
,
Yogesh Bahurupi
,
Sanjay Kalra
,
Nowneet Kumar Bhat
·
YOU?
·
· 2022
· Open Access
·
· DOI: https://doi.org/10.1136/bmjopen-2021-056994
YOU?
·
· 2022
· Open Access
·
· DOI: https://doi.org/10.1136/bmjopen-2021-056994
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.
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Metadata
- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.1136/bmjopen-2021-056994
- https://bmjopen.bmj.com/content/bmjopen/12/5/e056994.full.pdf
- OA Status
- gold
- Cited By
- 4
- References
- 27
- Related Works
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- OpenAlex ID
- https://openalex.org/W4281668257
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
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https://openalex.org/W4281668257Canonical identifier for this work in OpenAlex
- DOI
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https://doi.org/10.1136/bmjopen-2021-056994Digital Object Identifier
- Title
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Adjuvant testosterone therapy in chronic heart failure (ATTIC): a randomised open-label trialWork title
- Type
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articleOpenAlex work type
- Language
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enPrimary language
- Publication year
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2022Year of publication
- Publication date
-
2022-05-01Full publication date if available
- Authors
-
Minakshi Dhar, Kartik Mittal, Ashwin Parchani, Manu Sharma, Yogesh Bahurupi, Sanjay Kalra, Nowneet Kumar BhatList of authors in order
- Landing page
-
https://doi.org/10.1136/bmjopen-2021-056994Publisher landing page
- PDF URL
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https://bmjopen.bmj.com/content/bmjopen/12/5/e056994.full.pdfDirect link to full text PDF
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YesWhether a free full text is available
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goldOpen access status per OpenAlex
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https://bmjopen.bmj.com/content/bmjopen/12/5/e056994.full.pdfDirect OA link when available
- Concepts
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Medicine, Adjuvant, Attic, Heart failure, Open label, Testosterone (patch), Clinical trial, Alternative medicine, Internal medicine, Randomized controlled trial, Intensive care medicine, Physical therapy, Pathology, Structural engineering, Engineering, RoofTop concepts (fields/topics) attached by OpenAlex
- Cited by
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4Total citation count in OpenAlex
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2025: 2, 2023: 2Per-year citation counts (last 5 years)
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27Number of works referenced by this work
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10Other works algorithmically related by OpenAlex
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