. 2025 Feb 4;40(2):371-384.

doi: 10.1093/ndt/gfae156.

Heart failure events in randomized controlled trials for adults receiving maintenance dialysis: a meta-epidemiologic study

David Collister^{1

2

3}, Lonnie Pyne^{2

4

5}, Arrti A Bhasin⁴, Brendan Smyth^{6

7}, William Herrington⁸, Meg Jardine^{7

9}, Patrick B Mark¹⁰, Sunil Badve^{11

12

13}, Patrick Rossignol^{14

15}, Laura M Dember¹⁶, Christoph Wanner¹⁷, Justin Ezekowitz^{3

18}, P J Devereaux^{2

4

19}, Patrick Parfrey²⁰, Ron Gansevoort²¹, Michael Walsh^{1

2

4}

Affiliations

¹ Division of Nephrology, Department of Medicine, University of Alberta, Edmonton, Canada.
² Population Health Research Institute, Hamilton, Canada.
³ Canadian Vigour Center, Edmonton, Canada.
⁴ Department of Health Research Methodology, Evidence & Impact, McMaster University, Hamilton, Canada.
⁵ Division of Nephrology, Department of Medicine, McMaster University, Hamilton, Canada.
⁶ Department of Renal Medicine, St George Hospital, Kogarah, Australia.
⁷ NHMRC Clinical Trials Centre, University of Sydney, Camperdown, Australia.
⁸ MRC Population Health Research Unit, Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.
⁹ Department of Renal Medicine, Concord Repatriation General Hospital, Sydney, Australia.
¹⁰ School of Cardiovascular and Metabolic Health, University of Glasgow, Glasgow, UK.
¹¹ Department of Nephrology, St George Hospital, Sydney, NSW, Australia.
¹² Faculty of Medicine & Health, UNSW, Sydney, NSW, Australia.
¹³ Renal and Metabolic Division, The George Institute for Global Health, Sydney, NSW, Australia.
¹⁴ Centre d'Investigations Cliniques-Plurithématique 14-33, Université de Lorraine, Inserm U1116, CHRU Nancy, and F-CRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists), Nancy, France.
¹⁵ Medicine and Nephrology-Dialysis Departments, Princess Grace Hospital, and Monaco Private Hemodialysis Centre, Monaco, Monaco.
¹⁶ Renal-Electrolyte and Hypertension Division and Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
¹⁷ Department of Clinical Research and Epidemiology, DZHI and University Hospital, Würzburg, Germany.
¹⁸ Division of Cardiology, Department of Medicine, University of Alberta, Edmonton, Canada.
¹⁹ Divisions of Cardiology and Perioperative Medicine, Department of Medicine, McMaster University, Hamilton, Canada.
²⁰ Division of Nephrology, Department of Medicine, Faculty of Medicine, Memorial University Newfoundland, St. John's, Canada.
²¹ Department of Nephrology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.

PMID: 38986509
PMCID: PMC11792648
DOI: 10.1093/ndt/gfae156

Heart failure events in randomized controlled trials for adults receiving maintenance dialysis: a meta-epidemiologic study

David Collister et al. Nephrol Dial Transplant. 2025.

. 2025 Feb 4;40(2):371-384.

doi: 10.1093/ndt/gfae156.

Authors

Affiliations

¹ Division of Nephrology, Department of Medicine, University of Alberta, Edmonton, Canada.
² Population Health Research Institute, Hamilton, Canada.
³ Canadian Vigour Center, Edmonton, Canada.
⁴ Department of Health Research Methodology, Evidence & Impact, McMaster University, Hamilton, Canada.
⁵ Division of Nephrology, Department of Medicine, McMaster University, Hamilton, Canada.
⁶ Department of Renal Medicine, St George Hospital, Kogarah, Australia.
⁷ NHMRC Clinical Trials Centre, University of Sydney, Camperdown, Australia.
⁸ MRC Population Health Research Unit, Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.
⁹ Department of Renal Medicine, Concord Repatriation General Hospital, Sydney, Australia.
¹⁰ School of Cardiovascular and Metabolic Health, University of Glasgow, Glasgow, UK.
¹¹ Department of Nephrology, St George Hospital, Sydney, NSW, Australia.
¹² Faculty of Medicine & Health, UNSW, Sydney, NSW, Australia.
¹³ Renal and Metabolic Division, The George Institute for Global Health, Sydney, NSW, Australia.
¹⁴ Centre d'Investigations Cliniques-Plurithématique 14-33, Université de Lorraine, Inserm U1116, CHRU Nancy, and F-CRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists), Nancy, France.
¹⁵ Medicine and Nephrology-Dialysis Departments, Princess Grace Hospital, and Monaco Private Hemodialysis Centre, Monaco, Monaco.
¹⁶ Renal-Electrolyte and Hypertension Division and Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
¹⁷ Department of Clinical Research and Epidemiology, DZHI and University Hospital, Würzburg, Germany.
¹⁸ Division of Cardiology, Department of Medicine, University of Alberta, Edmonton, Canada.
¹⁹ Divisions of Cardiology and Perioperative Medicine, Department of Medicine, McMaster University, Hamilton, Canada.
²⁰ Division of Nephrology, Department of Medicine, Faculty of Medicine, Memorial University Newfoundland, St. John's, Canada.
²¹ Department of Nephrology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.

PMID: 38986509
PMCID: PMC11792648
DOI: 10.1093/ndt/gfae156

Abstract

Background and hypothesis: Heart failure is characterized as cardiac dysfunction resulting in elevated cardiac filling pressures with symptoms and signs of congestion. Distinguishing heart failure from other causes of similar presentations in patients with kidney failure is challenging but necessary, and is needed in randomized controlled trials (RCTs) to accurately estimate treatment effects. The objective of this study was to review heart failure events, their diagnostic criteria, and adjudication in RCTs of patients with kidney failure treated with dialysis. We hypothesized that heart failure events, diagnostic criteria, and adjudication were infrequently reported in RCTs in dialysis.

Methods: We conducted a meta-epidemiologic systematic review of RCTs from high-impact medical, nephrology, and cardiology journals from 2000 to 2020. RCTs were eligible if they enrolled adults receiving maintenance dialysis for kidney failure and evaluated any intervention.

Results: Of 561 RCTs in patients receiving dialysis, 36 (6.4%) reported heart failure events as primary (10, 27.8%) or secondary (31, 86.1%) outcomes. Ten of the 36 (27.8%) RCTs provided heart failure event diagnostic criteria and five of these (50%) adjudicated heart failure events. These 10 RCTs included event diagnostic criteria for heart failure or heart failure hospitalizations, and their criteria included dyspnoea (5/10), oedema (2/10), rales/crackles (4/10), chest X-ray pulmonary oedema or vascular redistribution (4/10), treatment in an acute setting (6/10), and ultrafiltration or dialysis (4/10). No study explicitly distinguished heart failure from volume overload secondary to non-adherence or underdialysis.

Conclusion: Overall, we found that heart failure events are infrequently reported in RCTs in dialysis and are heterogeneously defined. Further research is required to develop standardized diagnostic criteria that are practical and meaningful to patients and clinicians.

Keywords: dialysis; event diagnostic criteria; heart failure; meta-epidemiology.

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Conflict of interest statement

None declared.

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References

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Heart failure events in randomized controlled trials for adults receiving maintenance dialysis: a meta-epidemiologic study

Affiliations

Heart failure events in randomized controlled trials for adults receiving maintenance dialysis: a meta-epidemiologic study

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

Publication types

MeSH terms

Grants and funding

LinkOut - more resources

Full Text Sources

Medical