Development and testing of a new measure of health status for clinical trials in heart failure

1989 ◽  
Vol 4 (2) ◽  
pp. 101-107 ◽  
Author(s):  
Gordon H. Guyatt ◽  
Sharon Nogradi ◽  
Susan Halcrow ◽  
Joel Singer ◽  
Michael J. J. Sullivan ◽  
...  
Keyword(s):  
Heart Failure ◽  
Clinical Trials ◽  
Health Status

Abstract 310: Variability in Patient-Reported Health Status by NYHA Classification: Implications for Clinical Trials

2020 ◽  
Vol 13 (Suppl_1) ◽  
Author(s):  
Andy T Tran ◽  
Paul S Chan ◽  
Phillip G Jones ◽  
John Spertus
Keyword(s):  
Heart Failure ◽  
Clinical Trials ◽  
Health Status ◽  
Ejection Fraction ◽  
Nyha Class ◽  
Class I ◽  
Nyha Classification ◽  
Patient Reported ◽  
Patients With Heart Failure ◽  
Reported Health

Background: A foundation of current clinical trials is to categorize the severity of heart failure (HF) by New York Heart Association (NYHA) classification to ensure that enrolled patients have similar disease severity. Because the NYHA represents a clinician’s assessment of patients’ health status, it may vary from patients’ perspectives and can lead to more or less symptomatic patients being enrolled in clinical trials. We sought to directly compare the ranges of patient-reported health status, as assessed by the well-validated and reliable Kansas City Cardiomyopathy Questionnaire (KCCQ), with NYHA class in recent clinical studies. Methods: We used data from 2 contemporary HF clinical trials, HF-ACTION in patients with Heart Failure with Reduced Ejection Fraction (HFrEF) and TOPCAT in patients with Heart Failure with Preserved Ejection Fraction (HFpEF), and 1 prospective cohort study, the KCCQ Interpretability study (KCCQINT) in patients with HFrEF, where both NYHA and the KCCQ were contemporaneously collected. The distributions of KCCQ Overall Summary (KCCQ-os) scores by NYHA and the variation in assigned NYHA classes among patients with KCCQ scores ≥80 (congruent with NYHA Class I) were then described. Results: A total of 6,072 patients (mean age 64±12 years, 41% female) were included across the 3 studies. Figure 1 shows marked overlap in KCCQ scores across NYHA classes. In KCCQINT, 148 (27%) out of 545 patients reported a KCCQ-os score ≥80, of whom 39 (26%), 81 (55%) and 28 (19%) were coded as NYHA Class I, II and III. None were classified as NYHA Class IV. In HF-ACTION, 677 (32%) of 2129 patients reported a KCCQ-os score ≥80, of whom 548 (81%), 128 (19%) and 1 (<1%) were coded as NYHA Class II, III and IV, respectively. In TOPCAT, 484 (14%) out of 3398 patients reported a KCCQ-os score ≥80, of whom 410 (85%) and 74 (15%) were considered NYHA Class I-II and III-IV, respectively. Conclusions: Although the NYHA is used to identify similarly ill patients for enrollment in clinical trials, there is marked variability within and across studies in patients’ self-reported health status. Future trials should consider patient-reported outcome measures as the basis for defining patient eligibility to enroll a more homogenous cohort of disease severity.

PATIENT HEALTH STATUS TRAJECTORIES IN HEART FAILURE WITH RECOVERED EJECTION FRACTION

2019 ◽  
Vol 73 (9) ◽  
pp. 970
Author(s):  
Peter Wohlfahrt ◽  
Jose Nativi-Nicolau ◽  
Mingyuan Zhang ◽  
Craig Selzman ◽  
Tom Greene ◽  
...  
Keyword(s):  
Heart Failure ◽  
Health Status ◽  
Ejection Fraction ◽  
Patient Health Status ◽  
Patient Health

scholarly journals PCV87 IS MEASURING HEALTH STATUS BENEFICIAL IN HEART FAILURE PATIENTS?

2009 ◽  
Vol 12 (3) ◽  
pp. A157
Author(s):  
S Höfer ◽  
M Frick ◽  
G Pölzl ◽  
W Benzer
Keyword(s):  
Heart Failure ◽  
Health Status ◽  
Heart Failure Patients

scholarly journals Statins in Heart Failure: The Paradox Between Large Randomized Clinical Trials and Real Life

2012 ◽  
Vol 87 (6) ◽  
pp. 555-560 ◽  
Author(s):  
Paloma Gastelurrutia ◽  
Josep Lupón ◽  
Marta de Antonio ◽  
Agustin Urrutia ◽  
Crisanto Díez ◽  
...  
Keyword(s):  
Heart Failure ◽  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Real Life

Low-to-Moderate Alcohol Intake and Health Status in Heart Failure Patients

2005 ◽  
Vol 11 (5) ◽  
pp. 323-328 ◽  
Author(s):  
Adam C. Salisbury ◽  
John A. House ◽  
Mark W. Conard ◽  
Harlan M. Krumholz ◽  
John A. Spertus
Keyword(s):  
Heart Failure ◽  
Health Status ◽  
Alcohol Intake ◽  
Heart Failure Patients ◽  
Moderate Alcohol Intake
Sign in / Sign up

Export Citation Format

Share Document