title: Registry-Based Pragmatic Trials in Heart Failure: Current Experience and Future Directions.
abstract: 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.
  
  
  
  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.
authors.affiliation: Department of Medicine, Unit of Cardiology, Karolinska Institutet, Solna, Sweden. lars.lund@alumni.duke.edu.|Department of Cardiology, Karolinska University Hospital, 117 76, Stockholm, Sweden. lars.lund@alumni.duke.edu.
authors.forename: Lars H
authors.initials: LH
authors.lastname: Lund
authors.affiliation: Uppsala Clinical Research Center and Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden.
authors.forename: Jonas
authors.initials: J
authors.lastname: Oldgren
authors.affiliation: Uppsala Clinical Research Center and Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden.
authors.forename: Stefan
authors.initials: S
authors.lastname: James
mesh_terms: D002908:Chronic Disease; D005240:Feasibility Studies; D006333:Heart Failure / Q000628:therapy*; D006801:Humans; D018579:Patient Selection / Q000941:ethics; D064792:Pragmatic Clinical Trials as Topic / Q000941:ethics / Q000331:legislation & jurisprudence; D011446:Prospective Studies; D016032:Randomized Controlled Trials as Topic / Q000941:ethics / Q000331:legislation & jurisprudence; D012042:Registries
keywords: Cost; Heart failure; Pragmatic clinical trial; Prospective randomized clinical trial; Registry; Registry-based pragmatic trial; Registry-based prospective randomized clinical trial