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Current Heart Failure Reports
Published in: Current Heart Failure Reports 2/2017

Open Access 01-04-2017 | Clinical Trials (J Butler, Section Editor)

Registry-Based Pragmatic Trials in Heart Failure: Current Experience and Future Directions

Authors: Lars H. Lund, Jonas Oldgren, Stefan James

Published in: Current Heart Failure Reports | Issue 2/2017

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Abstract

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.

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.
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Metadata
Title
Registry-Based Pragmatic Trials in Heart Failure: Current Experience and Future Directions
Authors
Lars H. Lund
Jonas Oldgren
Stefan James
Publication date
01-04-2017
Publisher
Springer US
Published in
Current Heart Failure Reports / Issue 2/2017
Print ISSN: 1546-9530
Electronic ISSN: 1546-9549
DOI
https://doi.org/10.1007/s11897-017-0325-0

Other articles of this Issue 2/2017

Current Heart Failure Reports 2/2017 Go to the issue

Self-Care and Health Outcomes (R Gallagher and R Clark, Section Editors)

Role of the Pharmacist for Improving Self-care and Outcomes in Heart Failure

Biomarkers of Heart Failure (W H W Tang and J Grodin, Section Editors)

Clinical Phenotyping of Heart Failure with Biomarkers: Current and Future Perspectives

Pharmacologic Therapy (W H W Tang, Section Editor)

Potential Expanded Indications for Neprilysin Inhibitors

Pharmacologic Therapy (W H W Tang, Section Editor)

Diuretic Strategies in Acute Decompensated Heart Failure

Nonpharmacologic Therapy: Surgery, Ventricular Assist Devices, Biventricular Pacing, and Exercise (A Hasan, Section Editor)

Percutaneous Ventricular Restoration with a Partitioning Device for Ischemic Heart Failure Treatment

Self-Care and Health Outcomes (R Gallagher and R Clark, Section Editors)

Factors Related to Self-Care in Heart Failure Patients According to the Middle-Range Theory of Self-Care of Chronic Illness: a Literature Update

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