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Registry-Based Pragmatic Trials in Heart Failure: Current Experience and Future Directions
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.ORCID iD: 0000-0003-4413-9736
2017 (English)In: Current Heart Failure Reports, ISSN 1546-9530, E-ISSN 1546-9549, Vol. 14, no 2, p. 59-70Article in journal (Refereed) Published
Abstract [en]

PURPOSE OF REVIEW: Randomized controlled trials (RCTs) in heart failure (HF) are becoming increasingly complex and expensive to conduct and if positive deliver expensive therapy tested only in selected populations.

RECENT FINDINGS: Electronic health records and clinical cardiovascular quality registries are providing opportunities for pragmatic and registry-based prospective randomized clinical trials (RRCTs). Simplified regulatory, ethics, and consent procedures; recruitment integrated into real-world care; and simplified or automated baseline and outcome collection allow assessment of study power and feasibility, fast and efficient recruitment, delivery of generalizable findings at low cost, and potentially evidence-based and novel use of generic drugs with low costs to society. There have been no RRCTs in HF to date. Major challenges include generating funding, international collaboration, and the monitoring of safety and adherence for chronic HF treatments. Here, we use the Spironolactone Initiation Registry Randomized Interventional Trial in Heart Failure with Preserved Ejection Fraction (SPIRRIT-HFpEF), to be conducted in the Swedish Heart Failure Registry, to exemplify the advantages and challenges of HF RRCTs.

Summary: There have been no RRCTs in HF to date. Major challenges include generating funding, international collaboration, and the monitoring of safety and adherence for chronic HF treatments. Here, we use the Spironolactone Initiation Registry Randomized Interventional Trial in Heart Failure with Preserved Ejection Fraction (SPIRRIT-HFpEF), to be conducted in the Swedish Heart Failure Registry, to exemplify the advantages and challenges of HF RRCTs.

Place, publisher, year, edition, pages
2017. Vol. 14, no 2, p. 59-70
Keywords [en]
Cost, Heart failure, Pragmatic clinical trial, Prospective randomized clinical trial, Registry, Registry-based pragmatic trial, Registry-based prospective randomized clinical trial
National Category
Cardiac and Cardiovascular Systems
Identifiers
URN: urn:nbn:se:uu:diva-342944DOI: 10.1007/s11897-017-0325-0PubMedID: 28247180OAI: oai:DiVA.org:uu-342944DiVA, id: diva2:1185345
Available from: 2018-02-23 Created: 2018-02-23 Last updated: 2018-03-29Bibliographically approved

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Oldgren, JonasJames, Stefan

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