Evidence map›Paper›PMID 28681133›Full record

ReviewJournal of cardiovascular translational research2017

Innovative Clinical Trial Designs for Precision Medicine in Heart Failure with Preserved Ejection Fraction.

Sanjiv J Shah

Abstract readReview
In one paragraph

Review in Journal of cardiovascular translational research, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 1 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

23 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Article
  4. Review
  5. Review
  6. Article
  7. Article
  8. Review
  9. Update on Atrial Shunt Therapy for Treatment of Heart Failure.Structural heart : the journal of the Heart Team · 2022
    Review
  10. Review
  11. Review
  12. Review
  13. The PARAGON-HF trial: the sacubitril/valsartan in heart failure with preserved ejection fraction.European heart journal supplements : journal of the European Society of Cardiology · 2020
    Article
  14. Innovative highlights of clinical drug trial design.Translational research : the journal of laboratory and clinical medicine · 2020
    Review
  15. Review
  16. Article
  17. 20th Annual Feigenbaum Lecture: Echocardiography for Precision Medicine-Digital Biopsy to Deconstruct Biology.Journal of the American Society of Echocardiography : official publication of the American Society of Echocardiography · 2019
    Article
  18. Article
  19. Review
  20. Article
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

1 author.

Sanjiv J ShahT1 Center for Cardiovascular Therapeutics, Division of Cardiology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA. sanjiv.shah@northwestern.edu.ORCID http://orcid.org/0000-0002-5655-8201

Funding

Transition from Risk Factors to Early HF: Prevalence, Pathogenesis, and PhenomicsR01HL127028 · NHLBI · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI BERTONI, ALAIN GERALD, SHAH, SANJIV J · 2015 to 2018
$6.5M
Study of Cardiac Mechanics in Systemic HypertensionR01HL107577 · NHLBI · NORTHWESTERN UNIVERSITY AT CHICAGO · PI SHAH, SANJIV J · 2011 to 2019
$4.1M
NHLBI NIH HHS R01 HL107577NHLBI NIH HHS R01 HL127028
6 · The paper itself

Abstract

A major challenge in the care of patients with heart failure and preserved ejection fraction (HFpEF) is the lack of proven therapies due to disappointing results from randomized controlled trials (RCTs). The heterogeneity of the HFpEF syndrome and the use of conventional RCT designs are possible reasons underlying the failure of these trials. There are several factors-including the widespread adoption of electronic health records, decreasing costs of obtaining high-dimensional data, and the availability of a wide variety of potential therapeutics-that have evolved to enable more innovative clinical trial designs in HFpEF. Here, we review the current landscape of HFpEF RCTs and present several innovative RCT designs that could be implemented in HFpEF, including enrichment trials, adaptive trials, umbrella trials, basket trials, and machine learning-based trials (including examples for each). Our hope is that the description of the aforementioned innovative trial designs will stimulate new approaches to clinical trials in HFpEF.

Indexed as

Research DesignStroke VolumeHeart FailureHumansMachine LearningPhenotypePrecision MedicineRandomized Controlled Trials as TopicTreatment OutcomeClinical trialsHeart failure with preserved ejection fractionPersonalized medicinePrecision medicineTreatment

Identifiers

PMID28681133
PMCPMC5571647

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.