Document Type

Technical Report

Date of this Version

1-15-2008

Publication Source

Heart & Lung: The Journal of Acute and Critical Care

Volume

37

Issue

1

Start Page

28

Last Page

35

DOI

10.1016/j.hrtlng.2007.02.002

Abstract

Background

We examined the utility of an index of clinical exacerbations of heart failure (HF) as a surrogate measure of outcome for use in modestly sized clinical trials and observational studies.

Methods

Electronic records of 189 outpatients with HF in a US Veterans Affairs Medical Center were examined over a 2- to 3-year period. Data collected included patient characteristics, clinical exacerbations of HF, hospitalizations, and deaths. Subsets of patient were also assessed for HF-related level of functioning.

Results

Episodes of clinical exacerbation could be detected reliably (kappa = .83). An index of episodes (number of episodes divided by the time in years) was associated with lower quality of life, higher functional class, increased rate of HF hospitalization, poorer exercise tolerance, and up to 30% increased risk of mortality across 2 years.

Conclusions

The index of HF exacerbations is potentially a useful surrogate end point for use in clinical HF research.

Copyright/Permission Statement

© 2008. This manuscript version is made available under the CC-BY-NC-ND 4.0 license http://creativecommons.org/licenses/by-nc-nd/4.0/

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Date Posted: 02 November 2018

This document has been peer reviewed.