Evidence map›Paper›PMID 33406882›Full record

ReviewCirculation2021

Challenges of Cardio-Kidney Composite Outcomes in Large-Scale Clinical Trials.

Ravi B Patel, Jozine M Ter Maaten, João Pedro Ferreira, Finnian R McCausland, Sanjiv J Shah, Patrick Rossignol, Scott D Solomon, Muthiah Vaduganathan, Milton Packer, Aliza Thompson and 2 more

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Circulation, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 2 pooled it
–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

21 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Guideline
  2. Pooled it
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  4. Cardiorenal outcomes of weight loss interventions in people with CKD and type 2 diabetes.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2026
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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

12 authors.

Ravi B Patel *Division of Cardiology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL (R.B.P., S.J.S.).
Jozine M Ter Maaten *Department of Cardiology, University of Groningen, University Medical Centre, the Netherlands (J.M.T.M.).
João Pedro FerreiraUniversité de Lorraine, INSERM, Centre d'Investigations Cliniques, INI CRCT, and INSERM U1116, CHRU Nancy, France (J.P.F., P.R., F.Z.).
Finnian R McCauslandRenal Division, Department of Medicine (F.R.M.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA.
Sanjiv J ShahDivision of Cardiology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL (R.B.P., S.J.S.).
Patrick RossignolUniversité de Lorraine, INSERM, Centre d'Investigations Cliniques, INI CRCT, and INSERM U1116, CHRU Nancy, France (J.P.F., P.R., F.Z.).
Scott D SolomonHeart and Vascular Center (S.D.S., M.V.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA.
Muthiah VaduganathanHeart and Vascular Center (S.D.S., M.V.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA.
Milton PackerBaylor Heart and Vascular Institute, Baylor University Medical Center, Dallas, TX (M.P.).
Aliza ThompsonDivision of Cardiology and Nephrology, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD (A.T., N.S.).
Norman StockbridgeDivision of Cardiology and Nephrology, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD (A.T., N.S.).
Faiez ZannadUniversité de Lorraine, INSERM, Centre d'Investigations Cliniques, INI CRCT, and INSERM U1116, CHRU Nancy, France (J.P.F., P.R., F.Z.).

Funding

The Harvard Clinical and Translational Science CenterUL1TR002541 · NCATS · HARVARD MEDICAL SCHOOL · PI NADLER, LEE MARSHALL · 2018 to 2022
$93.0M
Northwestern University Clinical and Translational Science Institute (NUCATS)UL1TR001422 · NCATS · NORTHWESTERN UNIVERSITY AT CHICAGO · PI D'AQUILA, RICHARD · 2015 to 2023
$56.8M
Northwestern University Clinical and Translational Science Institute (NUCATS)KL2TR001424 · NCATS · NORTHWESTERN UNIVERSITY AT CHICAGO · PI SHARMA, LEENA · 2015 to 2023
$8.1M
NCATS NIH HHS KL2 TR001424NCATS NIH HHS UL1 TR001422NCATS NIH HHS UL1 TR002541
6 · The paper itself

Abstract

Patients with chronic cardiovascular or metabolic diseases, including diabetes, hypertension, obesity, and heart failure, often have comorbid kidney disease. Long-term outcomes are worse in the setting of both cardiac and kidney disease compared with either disease in isolation. In addition, the clinical presentations of certain acute cardiovascular events (such as heart failure) and worsening kidney function overlap and may be challenging to distinguish. Recently, certain novel treatments have demonstrated beneficial effects on both cardiac and kidney outcomes. Sodium-glucose cotransporter-2 inhibitors have exhibited concordant risk reduction and clinically important benefits in chronic kidney disease with and without diabetes, diabetes and established cardiovascular disease or multiple atherosclerotic vascular disease risk factors, and heart failure with reduced ejection fraction with and without diabetes. Primary trial results have revealed that sacubitril-valsartan therapy improves cardiovascular outcomes in patients with chronic heart failure with reduced ejection fraction and post hoc analyses suggest favorable kidney effects. A concordant pattern of kidney benefit with sacubitril-valsartan has also been observed in chronic heart failure with preserved ejection fraction. Given the complex interplay between cardiac and kidney disease and the possibility that treatments may show concordant cardio-kidney benefits, there has been recent interest in formally acknowledging, defining, and using composite cardio-kidney outcomes in future cardiovascular trials. This review describes potential challenges in use of such outcomes that should be considered and addressed before their incorporation into such trials.

Indexed as

AminobutyratesAngiotensin Receptor AntagonistsBiphenyl CompoundsCardiovascular DiseasesClinical Trials as TopicDiabetes Mellitus, Type 2Drug CombinationsHeart FailureHumansRenal Insufficiency, ChronicSodium-Glucose Transporter 2 InhibitorsTreatment OutcomeValsartanAminobutyratesAngiotensin Receptor AntagonistsBiphenyl CompoundsDrug Combinationssacubitril and valsartan sodium hydrate drug combinationSodium-Glucose Transporter 2 InhibitorsValsartancardiovascular diseasesclinical trialkidney diseases

Identifiers

PMID33406882
PMCPMC7920916

What OpenQuestion 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 OpenQuestion graph.