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

PARAGON-HF Investigators, Alvin Chandra, Muthiah Vaduganathan, Eldrin F. Lewis, Brian L. Claggett, Adel R. Rizkala, Wenyan Wang, Martin P. Lefkowitz, Victor C. Shi, Inder S. Anand, Junbo Ge, Carolyn S. P. Lam, Aldo P. Maggioni, Felipe Martinez, Milton Packer, Marc A. Pfeffer, Burkert Pieske, Margaret M. Redfield, Jean L. Rouleau, Dirk J. van VeldhuisenFaiez Zannad, Michael R. Zile, John J. V. McMurray, Scott D. Solomon*

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

20 Citations (Scopus)


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) (

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) (C) 2019 Published by Elsevier on behalf of the American College of Cardiology Foundation.

Original languageEnglish
Pages (from-to)862-874
Number of pages13
JournalJACC. Heart failure
Issue number10
Publication statusPublished - Oct-2019


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

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