Evidence map›Paper›PMID 35641010›Full record

Trial reportBMJ open2022

Adjuvant testosterone therapy in chronic heart failure (ATTIC): a randomised open-label trial.

Minakshi Dhar, Kartik Mittal, Ashwin Parchani, Manu Sharma, Yogesh Bahurupi, Sanjay Kalra, Nowneet Kumar Bhat

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMJ open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
0.6field-weighted citation impact, top 32% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 4 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 2 institutions in 1 country.

Minakshi DharInternal Medicine, All India Institute of Medical Sciences-Rishikesh, Rishikesh, Uttarakhand, India minakshi.dhar@rediffmail.com.ORCID 0000-0001-6336-5179
Kartik MittalInternal Medicine, All India Institute of Medical Sciences-Rishikesh, Rishikesh, Uttarakhand, India.
Ashwin ParchaniInternal Medicine, All India Institute of Medical Sciences-Rishikesh, Rishikesh, Uttarakhand, India.
Manu SharmaInternal Medicine, All India Institute of Medical Sciences-Rishikesh, Rishikesh, Uttarakhand, India.
Yogesh BahurupiCommunity and Family Medicine, All India Institute of Medical Sciences-Rishikesh, Rishikesh, Uttarakhand, India.ORCID 0000-0003-2433-1624
Sanjay KalraDepartment of Endocrinology, Bharti Hospital, Karnal, Haryana, India.
Nowneet Kumar BhatPediatrics, All India Institute of Medical Sciences-Rishikesh, Rishikesh, Uttarakhand, India.
All India Institute of Medical Sciences Rishikesh · INBharti Hospital · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionHeart 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.

methodsWe 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.

Indexed as

FrailtyHeart FailureAdultAgedChronic DiseaseHumansMaleQuality of LifeTestosteroneTestosteroneechocardiographygeriatric medicineheart failure

Identifiers

PMID35641010
PMCPMC9157332
OpenAlexW4281668257

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.