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Comparing Measures to Assess Health-Related Quality of Life in Heart Failure With Preserved Ejection Fraction.

ABSTRACT: OBJECTIVES:This study sought to compare the performance of 2 health-related quality of life (HRQOL) questionnaires in patients with heart failure with preserved ejection fraction (HFpEF). BACKGROUND:The ability to accurately assess HRQOL over time is important in the care of patients with heart failure. The validity and reliability of HRQOL tools including the Minnesota Living with Heart Failure Questionnaire (MLHFQ) and the Kansas City Cardiomyopathy Questionnaire (KCCQ) has not been fully determined or compared in patients with HFpEF. METHODS:Among patients with stable chronic HFpEF enrolled in the NEAT (Nitrate Effect on Activity Tolerance in Heart Failure) trial (n = 110), the study evaluated and compared reliability, validity, and responsiveness to change of the MLHFQ and KCCQ at baseline, 6 weeks, and 12 weeks. RESULTS:Internal consistency was good and comparable for MLHFQ and KCCQ domains measuring similar aspects of HRQOL at baseline including the MLHFQ physical (Cronbach's ? = 0.93) compared with the KCCQ clinical summary (? = 0.91), and the MLHFQ emotional (? = 0.92) compared with the KCCQ quality of life (? = 0.87). Correlations with New York Heart Association functional class (Spearman rho; rs= -0.37 vs. 0.30) and 6-min walk test (6MWT) (rs = 0.38 vs. -0.23) at baseline were slightly stronger for the KCCQ overall summary score than for the MLHFQ total score. The MLHFQ was more responsive to change in 6MWT based on responsiveness statistics. CONCLUSIONS:These data suggest that both the MLHFQ and KCCQ are reliable and valid tools to assess HRQOL in HFpEF. The KCCQ was more strongly correlated with baseline functional status parameters, while the MLHFQ was more responsive to improvement in 6MWT.

SUBMITTER: Napier R

PROVIDER: S-EPMC6026057 | biostudies-literature | 2018 Jul

REPOSITORIES: biostudies-literature

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Comparing Measures to Assess Health-Related Quality of Life in Heart Failure With Preserved Ejection Fraction.

Napier Rebecca R McNulty Steven E SE Eton David T DT Redfield Margaret M MM AbouEzzeddine Omar O Dunlay Shannon M SM

JACC. Heart failure 20180606 7

<h4>Objectives</h4>This study sought to compare the performance of 2 health-related quality of life (HRQOL) questionnaires in patients with heart failure with preserved ejection fraction (HFpEF).<h4>Background</h4>The ability to accurately assess HRQOL over time is important in the care of patients with heart failure. The validity and reliability of HRQOL tools including the Minnesota Living with Heart Failure Questionnaire (MLHFQ) and the Kansas City Cardiomyopathy Questionnaire (KCCQ) has not ...[more]

PMID: 29885952

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Project description:BackgroundPatients with heart failure with preserved ejection fraction have significant impairment in health-related quality of life. In the EMPEROR-Preserved trial (Empagliflozin Outcome Trial in Patients With Chronic Heart Failure With Preserved Ejection Fraction), we evaluated the efficacy of empagliflozin on health-related quality of life in patients with heart failure with preserved ejection fraction and whether the clinical benefit observed with empagliflozin varies according to baseline health status.MethodsHealth-related quality of life was measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ) at baseline and 12, 32, and 52 weeks. Patients were divided by baseline KCCQ Clinical Summary Score (CSS) tertiles, and the effect of empagliflozin on outcomes was examined. The effect of empagliflozin on KCCQ-CSS, Total Symptom Score, and Overall Summary Score was evaluated. Responder analyses were performed to compare the odds of improvement and deterioration in KCCQ related to treatment with empagliflozin.ResultsThe effect of empagliflozin on reducing the risk of time to cardiovascular death or heart failure hospitalization was consistent across baseline KCCQ-CSS tertiles (hazard ratio, 0.83 [95% CI, 0.69-1.00], 0.70 [95% CI, 0.55-0.88], and 0.82 [95% CI, 0.62-1.08] for scores <62.5, 62.5-83.3, and ≥83.3, respectively; P trend=0.77). Similar results were seen for total heart failure hospitalizations. Patients treated with empagliflozin had significant improvement in KCCQ-CSS versus placebo (+1.03, +1.24, and +1.50 at 12, 32, and 52 weeks, respectively; P<0.01); similar results were seen for Total Symptom Score and Overall Summary Score. At 12 weeks, patients on empagliflozin had higher odds of improvement ≥5 points (odds ratio, 1.23 [95% CI, 1.10-1.37]), ≥10 points (odds ratio, 1.15 [95% CI, 1.03-1.27]), and ≥15 points (odds ratio, 1.13 [95% CI, 1.02-1.26]) and lower odds of deterioration ≥5 points in KCCQ-CSS (odds ratio, 0.85 [95% CI, 0.75-0.97]). A similar pattern was seen at 32 and 52 weeks, and results were consistent for Total Symptom Score and Overall Summary Score.ConclusionsIn patients with heart failure with preserved ejection fraction, empagliflozin reduced the risk for major heart failure outcomes across the range of baseline KCCQ scores. Empagliflozin improved health-related quality of life, an effect that appeared early and was sustained for at least 1 year. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03057951.

Project description:BACKGROUND:The role of coronary microvascular disease and its impact on functional and energetic reserve in heart failure with preserved ejection fraction (HFpEF) remains unclear. We hypothesized that in response to submaximal pharmacologic stress (dobutamine), patients with HFpEF have impairment in left ventricular (LV) myocardial mechanical (external work [EW]), energetic (myocardial O2 consumption [MVO2]), and myocardial blood flow (MBF) reserve. We further assessed whether coupling of MBF to EW is impaired in HFpEF and associated with compensatory increases or pathological decreases in myocardial O2 extraction. Lastly, we assessed whether coupling of MVO2 to EW (mechanical efficiency) was impaired in HFpEF. METHODS AND RESULTS:In prospectively enrolled patients with HFpEF (n=19) and age/sex-matched healthy controls (n=19), we performed 11C-acetate positron emission tomography assessing MVO2 and MBF at rest and during dobutamine infusion. EW was calculated as stroke volume (echo)×end-systolic pressure×heart rate. At rest, compared with controls, patients with HFpEF had higher LV EW, MVO2, and MBF. With dobutamine, LV EW, MVO2, and MBF increased in both HFpEF and controls; however, the magnitude of increases was significantly smaller in HFpEF. In both groups, MBF increased in relation to EW, but in HFpEF, the slope of the relationship was significantly smaller than in controls. Myocardial O2 extraction was increased in HFpEF. Mechanical efficiency was similar in HFpEF and controls. In a post hoc analysis, HFpEF patients with LV hypertrophy (n=10) had significant reductions in LV mechanical efficiency relative to controls. CONCLUSIONS:In HFpEF during submaximal dobutamine stress, there is myocardial mechanical-, energetic- and flow-reserve dysfunction with impaired coupling of blood flow to demand and slight increases in myocardial O2 extraction. These findings provide evidence that coronary microvascular dysfunction is present in HFpEF, limits O2 supply relative to demand, and is associated with reserve dysfunction.

Project description:Approximately half of heart failure patients have a normal ejection fraction, a condition designated as heart failure with preserved ejection fraction (HFpEF). This heart failure subtype disproportionately affects women and the elderly and is commonly associated with other cardiovascular comorbidities, such as hypertension and diabetes. HFpEF is increasing at a steady rate and is predicted to become the leading cause of heart failure within a decade. HFpEF is characterized by impaired diastolic function, thought to be due to concentric remodeling of the heart along with increased stiffness of both the extracellular matrix and myofilaments. In addition, oxidative stress and inflammation are thought to have a role in HFpEF progression, along with endothelial dysfunction and impaired nitric oxide-cyclic guanosine monophosphate-protein kinase G signaling. Surprisingly a number of clinical studies have failed to demonstrate any benefit of drugs effective in heart failure with systolic dysfunction in HFpEF patients. Thus, HFpEF is one of the largest unmet needs in cardiovascular medicine, and there is a substantial need for new therapeutic approaches and strategies that target mechanisms specific for HFpEF. This conclusion is underscored by the recently reported disappointing results of the RELAX trial, which assessed the use of phosphodiesterase-5 inhibitor sildenafil for treating HFpEF. In animal models, endothelial nitric oxide synthase activators and If current inhibitors have shown benefit in improving diastolic function, and there is a rationale for assessing matrix metalloproteinase 9 inhibitors and nitroxyl donors. LCZ696, a combination drug of angiotensin II receptor blocker and neprilysin inhibitor, and the aldosterone receptor antagonist spironolactone are currently in clinical trial for treating HFpEF. Here we present an overview of the etiology and diagnosis of HFpEF that segues into a discussion of new therapeutic approaches emerging from basic research and drugs currently in clinical trial that primarily target diastolic dysfunction or imbalanced ventricular-arterial coupling.

Dataset Information

Comparing Measures to Assess Health-Related Quality of Life in Heart Failure With Preserved Ejection Fraction.

Publications

Comparing Measures to Assess Health-Related Quality of Life in Heart Failure With Preserved Ejection Fraction.

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