Elsevier

American Heart Journal

Volume 189, July 2017, Pages 177-183
American Heart Journal

Trial Design
Change the management of patients with heart failure: Rationale and design of the CHAMP-HF registry

https://doi.org/10.1016/j.ahj.2017.04.010Get rights and content

Abstract

Heart failure (HF) with reduced ejection fraction (HFrEF) is a common and costly condition that diminishes patients' health status and confers a poor prognosis. Despite the availability of multiple guideline-recommended pharmacologic and cardiac device therapies for patients with chronic HFrEF, outcomes remain suboptimal. Currently, there is limited insight into the rationale underlying clinical decisions by health care providers and patient factors that guide the use and intensity of outpatient HF treatments. A better understanding of current practice patterns has the potential to improve patients' outcomes. The CHAnge the Management of Patients with Heart Failure (CHAMP-HF) registry will evaluate the care and outcomes of patients with chronic HFrEF by assessing real-world treatment patterns, as well as the reasons for and barriers to medication treatment changes. CHAMP-HF will enroll approximately 5,000 patients with chronic HFrEF (left ventricular ejection fraction ≤40%) at approximately 150 US sites, and patients will be followed for a maximum duration of 24 months. Participating sites will collect data from both providers (HF history, examination findings, results of diagnostic studies, pharmacotherapy treatment patterns, decision-making factors, and clinical outcomes) and patients (medication adherence and patient-reported outcomes). The CHAMP-HF registry will provide a unique opportunity to study practice patterns and the adoption of new HF therapies across a diverse mix of health care providers and outpatient practices in the United States that care for HFrEF patients.

Section snippets

Registry objectives and outcomes

The primary objective of the CHAMP-HF registry is to examine rationale for HF treatment changes. The primary outcome will be the proportion of patients within categories of reasons for an HF treatment change (Table I). Secondary objectives include the following: assessment of reasons for nonpharmacological HF treatment changes, provider- and patient-reported decision-making factors and perceptions of treatment, and provider- and patient-reported HF-related health care resource utilization. Key

Study design

The CHAMP-HF registry will be a prospective, observational, nonrandomized study of adult outpatients with HFrEF at participating US sites. Patients with chronic HFrEF who are treated with at least 1 oral pharmacotherapy as part of routine outpatient HF management will be consecutively recruited. Sites will enroll patients during the course of an outpatient visit. Patients will be followed for a maximum duration of 24 months or until death or study withdrawal. Because this is a prospective

Study oversight and leadership

The CHAMP-HF registry is led by an independent steering committee comprised of HF specialists, cardiologists, and outcomes researchers. Enrolling centers will obtain site-specific institutional review board approval pursuant to local regulations. All patients will be required to sign written informed consent prior to collection of any study data. The CHAMP-HF registry is sponsored by Novartis Pharmaceuticals Corporation (East Hanover, NJ). Data will be managed by United BioSource Corporation

Conclusions

The CHAMP-HF registry will provide a unique opportunity to study the adoption of new HF therapies across a diverse mix of health care providers and outpatient facilities currently providing care to HFrEF patients in the United States. The study will focus on contemporary reasons for medication treatment changes and defining patient- and practice-level characteristics associated with the adoption of new clinical evidence. These data will have important implications for improving patient care by

Sources of funding

The CHAMP-HF registry is sponsored by Novartis Pharmaceuticals Corporation.

Conflict of interest disclosures

The following relationships exist related to this presentation:

Adam DeVore reports research funding from the American Heart Association, Amgen, and Novartis and serving as a consultant for Novartis.

Laine Thomas reports research funding from Novartis.

Nancy M. Albert reports serving as a consultant to Novartis.

Javed Butler has received research support from the National Institutes of Health and the European Union and serves as a consultant for Amgen, Bayer, Boehringer Ingelheim, Cardiocell, CVRx,

References (24)

  • Writing Committee Members et al.

    2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines

    Circulation

    (2013)
  • R.K. Cheng et al.

    Outcomes in patients with heart failure with preserved, borderline, and reduced ejection fraction in the Medicare population

    Am Heart J

    (2014)

    • Cited by (0)

    Deepak L. Bhatt, MD, MPH served as guest editor for this article.

    View full text
    © 2017 Elsevier Inc. All rights reserved.