Patient-Reported Frailty and Functional Status in Heart Failure With Preserved Ejection Fraction: Insights From VITALITY-HFpEF.

Background: The association between frailty and health status in patients with heart failure with preserved ejection fraction (HFpEF) is not well known.
Objectives: The authors examined the association between: 1) patient-reported frailty, measured by the Fried frailty phenotype, Kansas City Cardiomyopathy Questionnaire Physical Limitation Score (KCCQ-PLS), 6-minute walking distance (6MWD), and other baseline characteristics; 2) baseline frailty compared with KCCQ-PLS and 24-week 6MWD; 3) frailty and changes in KCCQ-PLS and 6MWD; and 4) vericiguat and frailty at 24 weeks.
Methods: In a post hoc analysis, patients in the VITALITY-HFpEF (Patient-reported Outcomes in Vericiguat-treated Patients With HFpEF) trial were categorized as not frail (0 symptoms), prefrail (1-2 symptoms), and frail (≥3 symptoms) according to patient-reported number of frailty symptoms. Correlations and linear regression models were used to examine the association between frailty and other measures, and between frailty and KCCQ-PLS at baseline with 24-week 6MWD.
Results: Among 739 patients, 27.3% were not frail, 37.6% were prefrail, and 35.0% were frail at baseline. Frail patients were older, more likely to be women, and less likely to be from Asia. Baseline KCCQ-PLS and 6MWD (mean ± SD) among not frail, prefrail, and frail patients was 68.2 ± 23.2, 61.7 ± 22.6, and 48.4 ± 23.8 and 328.5 ± 117.1 m, 310.8 ± 98.9 m, and 250.7 ± 104.3 m (P < 0.01 for both). After accounting for baseline 6MWD, frailty status at baseline, but not KCCQ-PLS, was significantly associated with 6MWD at 24 weeks. By 24 weeks, 47.5% of patients had no change in frailty, 45.5% had become less frail, and 7.0% had become more frail. Treatment with vericiguat did not alter frailty status at 24 weeks.
Conclusions: Patient-reported frailty is modestly correlated with both the KCCQ-PLS and 6MWD but offers prognostic insight into 6MWD at 24 weeks. (Patient-reported Outcomes in Vericiguat-treated Patients With HFpEF [VITALITY-HFpEF]; NCT03547583).
Competing Interests: Funding Support and Author Disclosures The VITALITY-HFpEF trial was funded by Bayer and Merck Sharp and Dohme Corp, a subsidiary of Merck and Co, Inc. Dr Lam has received research grant support from Bayer, the National Medical Research Council of Singapore, Boston Scientific, Roche Diagnostics, Medtronic, Vifor Pharma, and AstraZeneca; has received consulting fees from Merck, Bayer, Boston Scientific, Roche Diagnostics, Vifor Pharma, AstraZeneca, Novartis, Amgen, Janssen Research and Development LLC, Menarini, Boehringer Ingelheim, Abbott Diagnostics, Corvia, Stealth BioTherapeutics, Novo Nordisk, JanaCare, Biofourmis, Darma, Applied Therapeutics, MyoKardia, Cytokinetics, WebMD Global LLC, Radcliffe Group Ltd, and Corpus; has patent PCT/SG2016/050217 pending and patent 16/216929 pending; and is co-founder and nonexecutive director of eKo.ai. Dr Westerhout has received consulting fees from Bayer Canada. Dr Spertus has received research grant support from the National Institutes of Health, Abbott Vascular, and American College of Cardiology Foundation; has received consulting fees from Janssen, Novartis, Amgen, Myokardia/Bristol Myers Squibb, AstraZeneca, Bayer, and Merck and Co, Inc; has served on the scientific advisory board for United Healthcare; has served on the board of directors for Blue Cross Blue Shield of Kansas City; and owns the copyright to the Kansas City Cardiomyopathy Questionnaire, Seattle Angina Questionnaire, and Peripheral Artery Questionnaire. Dr Anstrom has received research grant support from Merck and Co, Inc, and the National Institutes of Health. Dr Blaustein is an employee of Merck and Co, Inc. Dr Ezekowitz has received research grant support and consulting fees from Bayer, Merck, Servier, Amgen, Sanofi, Novartis, Cytokinetics, American Regent, Otsuka, and Applied Therapeutics. Dr Pieske has received research grant support from Merck Sharp & Dohme, Bayer, and Servier; consulting fees from Merck Sharp & Dohme, Bayer, Servier, Bristol-Myers Squibb, MedScape, Daiichi Sankyo, and Novartis; and nonfinancial support from Merck Sharp & Dohme, Bayer, and Novartis. Dr Roessig is an employee of Bayer AG. Dr Butler has received consulting fees from Abbott, Adrenomed, Amgen, Array, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, CVRx, G3 Pharmaceutical, Impulse Dynamics, Innolife, Janssen, LivaNova, Luitpold, Medtronic, Merck, Novartis, Novo Nordisk, Roche, and Vifor. Dr Armstrong has received research grant support from Merck, Bayer, Boehringer Ingelheim, Boehringer Ingelheim/Eli Lilly, and CSL Limited; and consulting fees from Merck, Bayer, and Novo Nordisk. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
(Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)