Health-Related Quality of Life in Heart Failure With Preserved Ejection Fraction: The PARAGON-HF Trial

PARAGON-HF Investigators

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

Objectives: This study sought to describe baseline health-related quality of life (HRQL) in the PARAGON-HF (Prospective Comparison of ARNI with ARB Global Outcomes in HFpEF) trial, the largest heart failure with preserved ejection fraction (HFpEF) trial to date. Background: There are limited data characterizing HRQL in patients with HFpEF using validated metrics. Methods: The PARAGON-HF trial randomized symptomatic patients with HFpEF (≥45%) ≥50 years of age to either sacubitril/valsartan or valsartan. The study reports comprehensive baseline HRQL using Kansas City Cardiomyopathy Questionnaire (KCCQ) administered at randomization after active run-in period. The study then compares baseline HRQL with patients with heart failure with reduced ejection fraction (HFrEF) (≤40%) enrolled in the PARADIGM-HF (Prospective Comparison of ARNI with an ACE-Inhibitor to Determine Impact on Global Mortality and Morbidity in Heart Failure) trial. Forward multivariable stepwise regression modeling was performed separately in both trials to identify independent clinical correlates of KCCQ-Overall Summary (KCCQ-OS) score. PARADIGM-HF trial patients <50 years of age were excluded to enable comparison. Results: In the PARAGON-HF trial, 4,735 of 4,822 patients (mean age 73 ± 8 years; 48% men) completed baseline KCCQ at randomization. Mean KCCQ-OS score was 71. Women had worse mean KCCQ-OS score than men did. Patients in the PARAGON-HF trial reported lower KCCQ scores in nearly all domains when compared with the PARADIGM-HF trial (KCCQ-OS score 71 ± 19 vs. 73 ± 19; p < 0.001). The strongest independent clinical correlates of adverse HRQL in both the PARAGON-HF and PARADIGM-HF trials were New York Heart Association functional class, female gender, lower extremity edema, body mass index, angina, dyspnea, and paroxysmal nocturnal dyspnea. After accounting for these clinical correlates of adverse HRQL that were common to both HFpEF and HFrEF patients, KCCQ-OS score did not differ significantly. Conclusions: HRQL was largely worse in women and was similar in HFpEF and HFrEF after accounting for variation in demographics, functional status, and symptom burden. (Prospective Comparison of ARNI with ARB Global Outcomes in HFpEF [PARAGON-HF] NCT01920711; Prospective Comparison of ARNI with an ACE-Inhibitor to Determine Impact on Global Mortality and Morbidity in Heart Failure [PARADIGM-HF]; NCT01035255)

Original languageEnglish (US)
Pages (from-to)862-874
Number of pages13
JournalJACC: Heart Failure
Volume7
Issue number10
DOIs
StatePublished - Oct 2019
Externally publishedYes

Fingerprint

Heart Failure
Quality of Life
Cardiomyopathies
Valsartan
Random Allocation
Angiotensin-Converting Enzyme Inhibitors
Paroxysmal Dyspnea
Morbidity
Mortality
Surveys and Questionnaires
Dyspnea
Lower Extremity
Edema
Body Mass Index
Demography

Keywords

  • gender disparity
  • health-related quality of life
  • heart failure with preserved ejection fraction
  • heart failure with reduced ejection fraction
  • regional variation

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Health-Related Quality of Life in Heart Failure With Preserved Ejection Fraction : The PARAGON-HF Trial. / PARAGON-HF Investigators.

In: JACC: Heart Failure, Vol. 7, No. 10, 10.2019, p. 862-874.

Research output: Contribution to journalArticle

@article{79a67b2840124e14a165ea1cc182de0f,
title = "Health-Related Quality of Life in Heart Failure With Preserved Ejection Fraction: The PARAGON-HF Trial",
abstract = "Objectives: This study sought to describe baseline health-related quality of life (HRQL) in the PARAGON-HF (Prospective Comparison of ARNI with ARB Global Outcomes in HFpEF) trial, the largest heart failure with preserved ejection fraction (HFpEF) trial to date. Background: There are limited data characterizing HRQL in patients with HFpEF using validated metrics. Methods: The PARAGON-HF trial randomized symptomatic patients with HFpEF (≥45{\%}) ≥50 years of age to either sacubitril/valsartan or valsartan. The study reports comprehensive baseline HRQL using Kansas City Cardiomyopathy Questionnaire (KCCQ) administered at randomization after active run-in period. The study then compares baseline HRQL with patients with heart failure with reduced ejection fraction (HFrEF) (≤40{\%}) enrolled in the PARADIGM-HF (Prospective Comparison of ARNI with an ACE-Inhibitor to Determine Impact on Global Mortality and Morbidity in Heart Failure) trial. Forward multivariable stepwise regression modeling was performed separately in both trials to identify independent clinical correlates of KCCQ-Overall Summary (KCCQ-OS) score. PARADIGM-HF trial patients <50 years of age were excluded to enable comparison. Results: In the PARAGON-HF trial, 4,735 of 4,822 patients (mean age 73 ± 8 years; 48{\%} men) completed baseline KCCQ at randomization. Mean KCCQ-OS score was 71. Women had worse mean KCCQ-OS score than men did. Patients in the PARAGON-HF trial reported lower KCCQ scores in nearly all domains when compared with the PARADIGM-HF trial (KCCQ-OS score 71 ± 19 vs. 73 ± 19; p < 0.001). The strongest independent clinical correlates of adverse HRQL in both the PARAGON-HF and PARADIGM-HF trials were New York Heart Association functional class, female gender, lower extremity edema, body mass index, angina, dyspnea, and paroxysmal nocturnal dyspnea. After accounting for these clinical correlates of adverse HRQL that were common to both HFpEF and HFrEF patients, KCCQ-OS score did not differ significantly. Conclusions: HRQL was largely worse in women and was similar in HFpEF and HFrEF after accounting for variation in demographics, functional status, and symptom burden. (Prospective Comparison of ARNI with ARB Global Outcomes in HFpEF [PARAGON-HF] NCT01920711; Prospective Comparison of ARNI with an ACE-Inhibitor to Determine Impact on Global Mortality and Morbidity in Heart Failure [PARADIGM-HF]; NCT01035255)",
keywords = "gender disparity, health-related quality of life, heart failure with preserved ejection fraction, heart failure with reduced ejection fraction, regional variation",
author = "{PARAGON-HF Investigators} and Alvin Chandra and Muthiah Vaduganathan and Lewis, {Eldrin F.} and Claggett, {Brian L.} and Rizkala, {Adel R.} and Wenyan Wang and Lefkowitz, {Martin P.} and Shi, {Victor C.} and Anand, {Inder S.} and Junbo Ge and Lam, {Carolyn S.P.} and Maggioni, {Aldo P.} and Felipe Martinez and Milton Packer and Pfeffer, {Marc A.} and Burkert Pieske and Redfield, {Margaret M.} and Rouleau, {Jean L.} and {Van Veldhuisen}, {Dirk J.} and Faiez Zannad and Zile, {Michael R.} and McMurray, {John J.V.} and Solomon, {Scott D.}",
year = "2019",
month = "10",
doi = "10.1016/j.jchf.2019.05.015",
language = "English (US)",
volume = "7",
pages = "862--874",
journal = "JACC: Heart Failure",
issn = "2213-1779",
publisher = "Elsevier BV",
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TY - JOUR

T1 - Health-Related Quality of Life in Heart Failure With Preserved Ejection Fraction

T2 - The PARAGON-HF Trial

AU - PARAGON-HF Investigators

AU - Chandra, Alvin

AU - Vaduganathan, Muthiah

AU - Lewis, Eldrin F.

AU - Claggett, Brian L.

AU - Rizkala, Adel R.

AU - Wang, Wenyan

AU - Lefkowitz, Martin P.

AU - Shi, Victor C.

AU - Anand, Inder S.

AU - Ge, Junbo

AU - Lam, Carolyn S.P.

AU - Maggioni, Aldo P.

AU - Martinez, Felipe

AU - Packer, Milton

AU - Pfeffer, Marc A.

AU - Pieske, Burkert

AU - Redfield, Margaret M.

AU - Rouleau, Jean L.

AU - Van Veldhuisen, Dirk J.

AU - Zannad, Faiez

AU - Zile, Michael R.

AU - McMurray, John J.V.

AU - Solomon, Scott D.

PY - 2019/10

Y1 - 2019/10

N2 - Objectives: This study sought to describe baseline health-related quality of life (HRQL) in the PARAGON-HF (Prospective Comparison of ARNI with ARB Global Outcomes in HFpEF) trial, the largest heart failure with preserved ejection fraction (HFpEF) trial to date. Background: There are limited data characterizing HRQL in patients with HFpEF using validated metrics. Methods: The PARAGON-HF trial randomized symptomatic patients with HFpEF (≥45%) ≥50 years of age to either sacubitril/valsartan or valsartan. The study reports comprehensive baseline HRQL using Kansas City Cardiomyopathy Questionnaire (KCCQ) administered at randomization after active run-in period. The study then compares baseline HRQL with patients with heart failure with reduced ejection fraction (HFrEF) (≤40%) enrolled in the PARADIGM-HF (Prospective Comparison of ARNI with an ACE-Inhibitor to Determine Impact on Global Mortality and Morbidity in Heart Failure) trial. Forward multivariable stepwise regression modeling was performed separately in both trials to identify independent clinical correlates of KCCQ-Overall Summary (KCCQ-OS) score. PARADIGM-HF trial patients <50 years of age were excluded to enable comparison. Results: In the PARAGON-HF trial, 4,735 of 4,822 patients (mean age 73 ± 8 years; 48% men) completed baseline KCCQ at randomization. Mean KCCQ-OS score was 71. Women had worse mean KCCQ-OS score than men did. Patients in the PARAGON-HF trial reported lower KCCQ scores in nearly all domains when compared with the PARADIGM-HF trial (KCCQ-OS score 71 ± 19 vs. 73 ± 19; p < 0.001). The strongest independent clinical correlates of adverse HRQL in both the PARAGON-HF and PARADIGM-HF trials were New York Heart Association functional class, female gender, lower extremity edema, body mass index, angina, dyspnea, and paroxysmal nocturnal dyspnea. After accounting for these clinical correlates of adverse HRQL that were common to both HFpEF and HFrEF patients, KCCQ-OS score did not differ significantly. Conclusions: HRQL was largely worse in women and was similar in HFpEF and HFrEF after accounting for variation in demographics, functional status, and symptom burden. (Prospective Comparison of ARNI with ARB Global Outcomes in HFpEF [PARAGON-HF] NCT01920711; Prospective Comparison of ARNI with an ACE-Inhibitor to Determine Impact on Global Mortality and Morbidity in Heart Failure [PARADIGM-HF]; NCT01035255)

AB - Objectives: This study sought to describe baseline health-related quality of life (HRQL) in the PARAGON-HF (Prospective Comparison of ARNI with ARB Global Outcomes in HFpEF) trial, the largest heart failure with preserved ejection fraction (HFpEF) trial to date. Background: There are limited data characterizing HRQL in patients with HFpEF using validated metrics. Methods: The PARAGON-HF trial randomized symptomatic patients with HFpEF (≥45%) ≥50 years of age to either sacubitril/valsartan or valsartan. The study reports comprehensive baseline HRQL using Kansas City Cardiomyopathy Questionnaire (KCCQ) administered at randomization after active run-in period. The study then compares baseline HRQL with patients with heart failure with reduced ejection fraction (HFrEF) (≤40%) enrolled in the PARADIGM-HF (Prospective Comparison of ARNI with an ACE-Inhibitor to Determine Impact on Global Mortality and Morbidity in Heart Failure) trial. Forward multivariable stepwise regression modeling was performed separately in both trials to identify independent clinical correlates of KCCQ-Overall Summary (KCCQ-OS) score. PARADIGM-HF trial patients <50 years of age were excluded to enable comparison. Results: In the PARAGON-HF trial, 4,735 of 4,822 patients (mean age 73 ± 8 years; 48% men) completed baseline KCCQ at randomization. Mean KCCQ-OS score was 71. Women had worse mean KCCQ-OS score than men did. Patients in the PARAGON-HF trial reported lower KCCQ scores in nearly all domains when compared with the PARADIGM-HF trial (KCCQ-OS score 71 ± 19 vs. 73 ± 19; p < 0.001). The strongest independent clinical correlates of adverse HRQL in both the PARAGON-HF and PARADIGM-HF trials were New York Heart Association functional class, female gender, lower extremity edema, body mass index, angina, dyspnea, and paroxysmal nocturnal dyspnea. After accounting for these clinical correlates of adverse HRQL that were common to both HFpEF and HFrEF patients, KCCQ-OS score did not differ significantly. Conclusions: HRQL was largely worse in women and was similar in HFpEF and HFrEF after accounting for variation in demographics, functional status, and symptom burden. (Prospective Comparison of ARNI with ARB Global Outcomes in HFpEF [PARAGON-HF] NCT01920711; Prospective Comparison of ARNI with an ACE-Inhibitor to Determine Impact on Global Mortality and Morbidity in Heart Failure [PARADIGM-HF]; NCT01035255)

KW - gender disparity

KW - health-related quality of life

KW - heart failure with preserved ejection fraction

KW - heart failure with reduced ejection fraction

KW - regional variation

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