Evidence mapPaperPMID 39191464Full record

ArticleBMJ open2024

Effect of henagliflozin on left ventricular mass index in dialysis patients with HFpEF (HELD-HF): protocol for a multicentre, randomised, double-blind, placebo-controlled trial.

Hao Yan, Wei Wang, Ying Li, Yinghui Qi, Renhua Lu, Yijun Zhou, Weiming Zhang, Shang Liu, Huihua Pang, Yan Fang and 6 more

Abstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
field-weighted citation impact
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

5 citing papers in PubMed.

  1. Review
  2. Review
  3. Article
  4. Cardiac fibrosis: from mechanisms and models to medicines.Trends in pharmacological sciences · 2025
    Review
  5. 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

16 authors.

Hao YanDepartment of Nephrology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.ORCID 0000-0002-7312-8860
Wei WangDepartment of Cardiology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Ying LiDepartment of Nephrology, Shanghai Jiading District Central Hospital, Shanghai, China.
Yinghui QiDepartment of Nephrology, Shanghai Punan Hospital, Shanghai, China.
Renhua LuDepartment of Nephrology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.ORCID 0000-0003-3555-505X
Yijun ZhouDepartment of Nephrology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Weiming ZhangDepartment of Nephrology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Shang LiuDepartment of Nephrology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Huihua PangDepartment of Nephrology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Yan FangDepartment of Nephrology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Zhenyuan LiDepartment of Nephrology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Jieying WangClinical Center for Investigation, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Meng JiangDepartment of Cardiology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Jun PuDepartment of Cardiology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China guleyi@aliyun.com fangwei_sh@126.com pujun310@hotmail.com.ORCID 0000-0002-1245-9690
Leyi GuDepartment of Nephrology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China guleyi@aliyun.com fangwei_sh@126.com pujun310@hotmail.com.ORCID 0000-0003-4358-0132
Wei FangDepartment of Nephrology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China guleyi@aliyun.com fangwei_sh@126.com pujun310@hotmail.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionHeart failure with preserved ejection fraction (HFpEF) is a prevalent comorbidity among patients with end-stage kidney disease. Although sodium-glucose cotransporter 2 inhibitors are validated in treating heart failure and ameliorating left ventricular hypertrophy among non-dialysis patients, the effects on dialysis patients are unknown. We previously investigated the pharmacokinetics of henagliflozin in patients undergoing haemodialysis (HD) or peritoneal dialysis (PD) and clarified its safety. METHODS AND ANALYSIS: This multicentre, randomised, double-blind, placebo-controlled trial is being conducted at three hospitals in Shanghai, China. A target of 108 HD or PD patients with HFpEF are randomly allocated to treatment group (henagliflozin 5 mg/day in addition to standard therapy) or control group (placebo with standard therapy) at a ratio of 1:1. All subjects will be followed up for 24 weeks. The primary outcome is change in echocardiography-measured left ventricular mass index. The secondary interests include changes in left atrial volume index, E/e', e' and N-terminal pro-B-type natriuretic peptide (NT-proBNP). Intergroup comparisons of change in echocardiography-related outcomes from baseline to 24 weeks are based on a linear regression model adjusted for baseline values (analysis of covariance), and repeated measure analysis of variance with Bonferroni adjustment is employed for comparison of change in NT-proBNP. Subgroup analyses of the primary and secondary outcomes are conducted to determine whether the effect of henagliflozin varies according to dialysis modality. The χ ETHICS AND DISSEMINATION: This trial has been approved by the Ethics Committee of Renji Hospital, School of Medicine, Shanghai Jiao Tong University (LY2023-127-B). All participants provide written informed consent before screening. The results of the trial will be disclosed completely in international peer-reviewed journals. Both positive and negative results will be reported. TRIAL REGISTRATION NUMBER: ChiCTR2300073169.

Indexed as

Heart FailureKidney Failure, ChronicRenal DialysisAdultAgedChinaDouble-Blind MethodEchocardiographyFemaleHeart VentriclesHumansHypertrophy, Left VentricularMaleMiddle AgedMulticenter Studies as TopicRandomized Controlled Trials as TopicSodium-Glucose Transporter 2 InhibitorsDialysisHeart failureRandomized Controlled Trial

Identifiers

PMID39191464
PMCPMC11404262

What Socratic holds

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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 Socratic graph.