Clinical exacerbations as a surrogate end point in heart failure research

Steven L. Sayers; Barbara Riegel; Lee R. Goldberg; James C. Coyne; Frederick F. Samaha

doi:10.1016/j.hrtlng.2007.02.002

Clinical exacerbations as a surrogate end point in heart failure research

Steven L. Sayers^*, Barbara Riegel, Lee R. Goldberg, James C. Coyne, Frederick F. Samaha

^*Corresponding author for this work

Health Psychology Research (HPR)

Research output: Contribution to journal › Article › Academic › peer-review

1 Citation (Scopus)

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.

Original language	English
Pages (from-to)	28-35
Number of pages	8
Journal	Heart and lung
Volume	37
Issue number	1
DOIs	https://doi.org/10.1016/j.hrtlng.2007.02.002
Publication status	Published - 2008

Keywords

LEFT-VENTRICULAR DYSFUNCTION
ASSOCIATION
MORTALITY
SURVIVAL
HEALTH
BLACK
RACE

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title = "Clinical exacerbations as a surrogate end point in heart failure research",

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.",

keywords = "LEFT-VENTRICULAR DYSFUNCTION, ASSOCIATION, MORTALITY, SURVIVAL, HEALTH, BLACK, RACE",

author = "Sayers, {Steven L.} and Barbara Riegel and Goldberg, {Lee R.} and Coyne, {James C.} and Samaha, {Frederick F.}",

year = "2008",

doi = "10.1016/j.hrtlng.2007.02.002",

language = "English",

volume = "37",

pages = "28--35",

journal = "Heart and lung",

issn = "0147-9563",

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TY - JOUR

T1 - Clinical exacerbations as a surrogate end point in heart failure research

AU - Sayers, Steven L.

AU - Riegel, Barbara

AU - Goldberg, Lee R.

AU - Coyne, James C.

AU - Samaha, Frederick F.

PY - 2008

Y1 - 2008

N2 - 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.

AB - 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.

KW - LEFT-VENTRICULAR DYSFUNCTION

KW - ASSOCIATION

KW - MORTALITY

KW - SURVIVAL

KW - HEALTH

KW - BLACK

KW - RACE

U2 - 10.1016/j.hrtlng.2007.02.002

DO - 10.1016/j.hrtlng.2007.02.002

M3 - Article

SN - 0147-9563

VL - 37

SP - 28

EP - 35

JO - Heart and lung

JF - Heart and lung

IS - 1

ER -

Clinical exacerbations as a surrogate end point in heart failure research

Abstract

Keywords

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