scholarly journals Rationale and Design of the ADIDAS Study: Association Between Dapagliflozin-Induced Improvement and Anemia in Heart Failure Patients

2021 ◽  
Author(s):  
Jianping Zeng ◽  
Yunlong Zhu ◽  
Wenjiao Zhao ◽  
Mingxing Wu ◽  
Haobo Huang ◽  
...  
Keyword(s):  
Heart Failure ◽  
Kansas City ◽  
Cardiovascular Death ◽  
Double Blind ◽  
Once Daily ◽  
Kansas City Cardiomyopathy Questionnaire ◽  
Beneficial Effects ◽  
Patients With Heart Failure ◽  
Study Association ◽  
Registration Date

Abstract Background Heart failure (HF) is one of the most serious health concerns worldwide. Anemia is a highly prevalent comorbidity and outcome predictor in HF patients. Sodium glucose co-transport 2 (SGLT2) inhibitors have been demonstrated to reduce the risk of cardiovascular death and HF hospitalization in HF patients. Purpose This investigator-initiated, interventional, prospective, double-blind, multicenter study is designed to investigate whether anemia correction is one of the prerequisites and determinants related to the beneficial effects of dapagliflozin in HF patients. Methods and Results Up to 2030 HF participants receiving standard care will be randomly assigned to either oral dapagliflozin 10 mg once daily or placebo 10 mg once daily for 12 months. The primary outcome is the composite incidence of hospital admission for HF and all-cause death. Secondary outcomes include change in the Kansas City Cardiomyopathy Questionnaire (KCCQ) score and change in 6-min walk distance and hemoglobin level. Patients will be followed for 12 months after randomization. Conclusions The ADIDAS trial offers an opportunity to assess the hemoglobin change and association between hemoglobin change and readmissions due to heart failure and all-cause death in patients with heart failure treated with dapagliflozin or placebo. This study could highlight if dynamic hemoglobin change is related to the outcome for HF patients. Trial Registration ClinicalTrials.gov; NCT04707261. Registration date, 2020/12/01, “retrospectively registered”

scholarly journals Impact of Chronic Obstructive Pulmonary Disease in Patients With Heart Failure With Preserved Ejection Fraction: Insights From PARAGON‐HF

2021 ◽  
Author(s):  
Leanne Mooney ◽  
Nathaniel M. Hawkins ◽  
Pardeep S. Jhund ◽  
Margaret M. Redfield ◽  
Muthiah Vaduganathan ◽  
...  
Keyword(s):  
Heart Failure ◽  
Ejection Fraction ◽  
Kansas City ◽  
Cardiovascular Death ◽  
Chronic Obstructive ◽  
Preserved Ejection Fraction ◽  
Heart Failure Hospitalization ◽  
Obstructive Pulmonary Disease ◽  
Kansas City Cardiomyopathy Questionnaire ◽  
Patients With Heart Failure

Background Little is known about the impact of chronic obstructive pulmonary disease (COPD) in patients with heart failure with preserved ejection fraction (HFpEF). Methods and Results We examined outcomes in patients with heart failure with preserved ejection fraction, according to COPD status, in the PARAGON‐HF (Prospective Comparison of Angiotensin Receptor Neprilysin Inhibitor With Angiotensin Receptor Blocker Global Outcomes in Heart Failure With Preserved Ejection Fraction) trial. The primary outcome was a composite of first and recurrent hospitalizations for heart failure and cardiovascular death. Of 4791 patients, 670 (14%) had COPD. Patients with COPD were more likely to be men (58% versus 47%; P <0.001) and had worse New York Heart Association functional class (class III/IV 24% versus 19%), worse Kansas City Cardiomyopathy Questionnaire Clinical Summary Scores (69 versus 76; P <0.001) and more frequent history of heart failure hospitalization (54% versus 47%; P <0.001). The decrement in Kansas City Cardiomyopathy Questionnaire Clinical Summary Scores with COPD was greater than for other common comorbidities. Patients with COPD had echocardiographic right ventricular enlargement, higher serum creatinine (100 μmol/L versus 96 μmol/L) and neutrophil‐to‐lymphocyte ratio (2.7 versus 2.5), than those without COPD. After multivariable adjustment, COPD was associated with worse outcomes: adjusted rate ratio for the primary outcome 1.51 (95% CI, 1.25–1.83), total heart failure hospitalization 1.54 (95% CI, 1.24–1.90), cardiovascular death (adjusted hazard ratio [HR], 1.42; 95% CI, 1.10–1.82), and all‐cause death (adjusted HR, 1.52; 95% CI, 1.25–1.84). COPD was associated with worse outcomes than other comorbidities and Kansas City Cardiomyopathy Questionnaire Clinical Summary Scores declined more in patients with COPD than in those without. Conclusions Approximately 1 in 7 patients with heart failure with preserved ejection fraction had concomitant COPD, which was associated with greater functional limitation and a higher risk of heart failure hospitalization and death. Registration URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01920711 .

Kansas City Cardiomyopathy Questionnaire Administered to Hospitalized Patients With Heart Failure

2016 ◽  
Vol 24 (2) ◽  
pp. 245-257
Author(s):  
Rebecca Tucker ◽  
Jill R. Quinn ◽  
Ding-Geng (Din) Chen ◽  
Leway Chen
Keyword(s):  
Heart Failure ◽  
Factor Analysis ◽  
Confirmatory Factor Analysis ◽  
Psychometric Properties ◽  
Convergent Validity ◽  
Kansas City ◽  
Community Dwelling ◽  
Kansas City Cardiomyopathy Questionnaire ◽  
Patients With Heart Failure ◽  
Confirmatory Factor

Background and Purpose: The psychometric properties of the Kansas City Cardiomyopathy Questionnaire (KCCQ) have been examined primarily in community-dwelling patients with heart failure (HF). The objective of this research was to examine the properties of the KCCQ administered to patients hospitalized with HF (N = 233). Methods: Confirmatory factor analysis, Cronbach’s alphas, and correlations were performed to examine the scale’s dimensions, reliability, and validity. Results: Confirmatory factor analysis indicated a 5-factor solution (63.6% of the variance). The Cronbach’s alpha levels were greater than .70, except for the self-efficacy dimension (.60). Convergent validity was not verified between the KCCQ and several illness severity measures. Conclusions: The psychometric properties of the KCCQ may be different based on the population in which the KCCQ is administered, which may have clinical implications.

scholarly journals Quality of life and disease experience in patients with heart failure with reduced ejection fraction in Spain: a mixed-methods study

BMJ Open ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. e053216
Author(s):  
Raül Rubio ◽  
Beatriz Palacios ◽  
Luis Varela ◽  
Raquel Fernández ◽  
Selene Camargo Correa ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Heart Failure ◽  
Ejection Fraction ◽  
Kansas City ◽  
Mixed Methods Study ◽  
Kansas City Cardiomyopathy Questionnaire ◽  
Reduced Ejection Fraction ◽  
Patients With Heart Failure ◽  
Disease Experience

ObjectivesTo gather insights on the disease experience of patients with heart failure (HF) with reduced ejection fraction (HFrEF), and assess how patients’ experiences and narratives related to the disease complement data collected through standardised patient-reported outcome measures (PROMs). Also, to explore new ways of evaluating the burden experienced by patients and caregivers.DesignObservational, descriptive, multicentre, cross-sectional, mixed-methods study.SettingSecondary care, patient’s homes.ParticipantsTwenty patients with HFrEF (New York Heart Association (NYHA) classification I–III) aged 38–85 years.MeasuresPROMs EuroQoL 5D-5L (EQ-5D-5L) and Kansas City Cardiomyopathy Questionnaire and patient interview and observation.ResultsA total of 20 patients with HFrEF participated in the study. The patients’ mean (SD) age was 72.5 (11.4) years, 65% were male and were classified inNYHA functional classes I (n=4), II (n=7) and III (n=9). The study showed a strong impact of HF in the patients’ quality of life (QoL) and disease experience, as revealed by the standardised PROMs (EQ-5D-5L global index=0.64 (0.36); Kansas City Cardiomyopathy Questionnaire total symptom score=71.56 (20.55)) and the in-depth interviews. Patients and caregivers often disagreed describing and evaluating perceived QoL, as patients downplayed their limitations and caregivers overemphasised the poor QoL of the patients. Patients related current QoL to distant life experiences or to critical moments in their disease, such as hospitalisations. Anxiety over the disease progression is apparent in both patients and caregivers, suggesting that caregiver-specific tools should be developed.ConclusionsPROMs are an effective way of assessing symptoms over the most recent time period. However, especially in chronic diseases such as HFrEF, PROM scores could be complemented with additional tools to gain a better understanding of the patient’s status. New PROMs designed to evaluate and compare specific points in the life of the patient could be clinically more useful to assess changes in health status.

scholarly journals Empagliflozin, Health Status, and Quality of Life in Patients with Heart Failure and Preserved Ejection Fraction: The EMPEROR-Preserved Trial

Circulation ◽  
2021 ◽  
Author(s):  
Javed Butler ◽  
Gerasimos Filippatos ◽  
Tariq Jamal Siddiqi ◽  
Martina Brueckmann ◽  
Michael Böhm ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Heart Failure ◽  
Health Status ◽  
Ejection Fraction ◽  
Kansas City ◽  
Cardiovascular Death ◽  
Summary Score ◽  
Preserved Ejection Fraction ◽  
Patients With Heart Failure

Background: Patients with heart failure and preserved ejection fraction (HFpEF) have significant impairment in health-related quality of life (HRQoL). In EMPEROR-Preserved, we evaluated the efficacy of empagliflozin on HRQoL in patients with HFpEF and whether the clinical benefit observed with empagliflozin varies according to baseline health status. Methods: HRQoL was measured using the Kansas City Cardiomyopathy Questionnaire (KCCQ) at baseline, 12, 32 and 52 weeks. Patients were divided by baseline KCCQ Clinical Summary Score (CSS) tertiles and the effect of empagliflozin on outcomes were examined. The effect of empagliflozin on KCCQ-CSS, Total Symptom Score (TSS) and Overall Summary Score (OSS) were evaluated. Responder analyses were performed to compare the odds of improvement and deterioration in KCCQ related to treatment with empagliflozin. Results: The effect of empagliflozin on reducing the risk of time to cardiovascular death or HF hospitalization was consistent across baseline KCCQ-CSS tertiles (HR 0.83 [0.69-1.00], HR 0.70 [0.55-0.88] and HR 0.82 [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 HF 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 TSS and OSS. At 12 weeks, patients on empagliflozin had higher odds of improvement ≥5 points (OR 1.23; 95%CI 1.10, 1.37), ≥10 points (1.15; 95%CI 1.03, 1.27), and ≥15 points (1.13; 95%CI 1.02, 1.26) and lower odds of deterioration ≥5 points in KCCQ-CSS (0.85; 95%CI 0.75, 0.97). A similar pattern was seen at 32 and 52 weeks, and results were consistent for TSS and OSS. Conclusions: In patients with HFpEF, empagliflozin reduced the risk for major HF outcomes across the range of baseline KCCQ scores. Empagliflozin improved HRQoL, an effect that appeared early and was sustained for at least one year.

scholarly journals Health status measured by Kansas City Cardiomyopathy Questionnaire-12 in primary prevention implantable cardioverter defibrillator patients with heart failure

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Gustav Mattsson ◽  
Marita Wallhagen ◽  
Peter Magnusson
Keyword(s):  
Heart Failure ◽  
Atrial Fibrillation ◽  
Health Status ◽  
Primary Prevention ◽  
Kansas City ◽  
Summary Score ◽  
Kansas City Cardiomyopathy Questionnaire ◽  
Patients With Heart Failure ◽  
The Mean

Abstract Background Self-reported health status as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) in patients with primary prevention implantable cardioverter defibrillators (ICDs) has mainly been reported from randomized trials. However, these studies are often limited to short follow-up and are subject to selection bias. The aim of this study was to assess KCCQ-12 in patients with primary prevention ICD due to either ischemic or nonischemic heart failure. Methods This cross-sectional observational study included all patients in Region Gävleborg, Sweden, who because of primary prevention due to heart failure, had an ICD or underwent device replacement between 2007 and 2017. After validation using medical records patients were sent and returned the KCCQ-12 by regular mail. Results A total of 118 questionnaires were analyzed (response rate 71.1%). The mean age was 70.9 ± 9.8 years, and a minority was female (n = 20, 16.9%). The mean overall summary score was 71.5 ± 22.4, there was no significant difference between ischemic and nonischemic heart failure (69.5 ± 23.1 vs. 74.4 ± 21.3; p = 0.195). Atrial fibrillation at baseline was associated with lower score for the domains Symptom frequency (70.2 ± 23.2 vs. 82.2 ± 19.2; p = 0.006) and Social limitation (62.1 ± 26.0 vs. 75.6 ± 26.6; p = 0.006) as well as the overall summary score (63.9 ± 21.3 vs. 74.8 ± 22.2; p = 0.004). Conclusion In a real-world setting, primary prevention ICD patients with heart failure report an acceptable disease-specific health status at long-term follow-up. Ischemic and nonischemic etiology showed similar health status whereas atrial fibrillation was associated with worse outcome.

scholarly journals Empagliflozin in Patients With Heart Failure: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

2021 ◽  
Vol 8 ◽  
Author(s):  
Deng Pan ◽  
Lin Xu ◽  
Pengfei Chen ◽  
Huiping Jiang ◽  
Dazhuo Shi ◽  
...  
Keyword(s):  
Heart Failure ◽  
Randomized Controlled Trials ◽  
Kansas City ◽  
Meta Analysis ◽  
Cardiovascular Death ◽  
Cochrane Library ◽  
Controlled Trials ◽  
Continuous Variables ◽  
Randomized Controlled ◽  
Patients With Heart Failure

Purpose: The purpose of the study is to evaluate the effect of empagliflozin in patients with heart failure (HF).Method: We performed a systematic search of PubMed, EMBASE, and the Cochrane Library database through January 20, 2021. Randomized controlled trials (RCTs) were included that compared empagliflozin and placebo in patients with HF. Dichotomous variables were expressed as risk ratios (RRs) with 95% confidence intervals (CIs). Continuous variables were calculated and expressed as mean differences (MD) and standard deviation (SD). Meta-analysis was conducted using a random-effects model on outcomes with high heterogeneity.Results: Seven studies were included in our meta-analysis (n = 5,150). Significant differences were observed in a composite of cardiovascular death or hospitalization for worsening heart failure [RR: 0.77 (95% CI 0.68–0.87); I2 = 18%; P &lt; 0.0001), hospitalization for worsening heart failure [RR: 0.71 (95% CI 0.61–0.82); I2 = 0%; P &lt; 0.00001], changes in Kansas City Cardiomyopathy Questionnaire (KCCQ) score [MD: 1.70 (95% CI 1.67–1.73); I2 = 0%; P &lt; 0.00001], and changes in body weight [MD: −1.43 (95% CI −2.15 to −0.72); I2 = 84%; P &lt; 0.0001) from baseline. However, empagliflozin did not show a better change in the 6-min walk test (6MWT) [MD: 34.06 (95% CI −29.75–97.88); I2 = 97%; P = 0.30] or NT-proBNP [MD: −98.36 (95% CI, −225.83–29.11); I2 = 68%; P = 0.13] from baseline.Conclusion: The findings suggest that empagliflozin was effective in reducing a composite of cardiovascular death or hospitalization for worsening heart failure. Further well-designed RCTs are needed to evaluate the long-term effect of empagliflozin in patients with HF.PROSPERO: CRD42021231712.

scholarly journals Mapping the Kansas City Cardiomyopathy Questionnaire (KCCQ) Onto EQ-5D-3L in Heart Failure Patients: Results for the Japanese and UK Value Sets

2020 ◽  
Vol 5 (2) ◽  
pp. 238146832097160
Author(s):  
Matthias Hunger ◽  
Jennifer Eriksson ◽  
Stephane A. Regnier ◽  
Katsuya Mori ◽  
John A. Spertus ◽  
...  
Keyword(s):  
Heart Failure ◽  
Kansas City ◽  
Model Performance ◽  
Cost Utility ◽  
Least Square ◽  
Double Blind ◽  
Data Set ◽  
Kansas City Cardiomyopathy Questionnaire ◽  
Item Level ◽  
Value Sets

Background. Health technology assessment bodies in several countries, including Japan and the United Kingdom, recommend mapping techniques to obtain utility scores in clinical trials that do not have a preference-based measure of health. This study sought to develop mapping algorithms to predict EQ-5D-3L scores from the Kansas City Cardiomyopathy Questionnaire (KCCQ) in patients with heart failure (HF). Methods. Data from the randomized, double-blind PARADIGM-HF trial were analyzed, and EQ-5D-3L scores were calculated using the Japanese and UK value sets. Several different model specifications were explored to best fit EQ-5D data collected at baseline with KCCQ scores, including ordinary least square regression, two-part, Tobit, and three-part models. Generalized estimating equations models were also fitted to analyze longitudinal EQ-5D data. To validate model predictions, the data set was split into a derivation ( n = 4,465) from which the models were developed and a separate sample ( n = 1,892) for validation. Results. There were only small differences between the different model classes tested. Model performance and predictive power was better for the item-level models than for the models including KCCQ domain scores. R2 statistics for the item-level models ranged from 0.45 to 0.52. Mean absolute error in the validation sample was 0.10 for the models using the Japanese value set and 0.114 for the UK models. All models showed some underprediction of utility above 0.75 and overprediction of utility below 0.5, but performed well for population-level estimates. Conclusions. Using data from a large clinical trial in HF, we found that EQ-5D-3L scores can be estimated from responses to the KCCQ and can facilitate cost-utility analysis from existing HF trials where only the KCCQ was administered. Future validation in other HF populations is warranted.

scholarly journals Cardiovascular biomarkers in patients with acute decompensated heart failure randomized to sacubitril-valsartan or enalapril in the PIONEER-HF trial

2019 ◽  
Vol 40 (40) ◽  
pp. 3345-3352 ◽  
Author(s):  
David A Morrow ◽  
Eric J Velazquez ◽  
Adam D DeVore ◽  
Margaret F Prescott ◽  
Carol I Duffy ◽  
...  
Keyword(s):  
Heart Failure ◽  
Acute Decompensated Heart Failure ◽  
High Sensitivity ◽  
Decompensated Heart Failure ◽  
Cardiovascular Death ◽  
Double Blind ◽  
Reduced Ejection Fraction ◽  
Treatment Groups ◽  
Myocardial Stress ◽  
Patients With Heart Failure

Abstract Aims Circulating high-sensitivity cardiac troponin (hsTn) and soluble ST2 (sST2) reflect myocardial stress in patients with heart failure (HF). Production of cyclic guanosine 3′5′ monophosphate (cGMP) in response to activation of natriuretic peptide receptors reduces cardiac afterload and preload. We assessed the effects of sacubitril/valsartan on these biomarkers in patients with reduced ejection fraction and acute decompensated HF (ADHF). Methods and results PIONEER-HF was a randomized, double-blind trial of sacubitril/valsartan vs. enalapril in hospitalized patients with ADHF following haemodynamic stabilization. We measured circulating hsTnT, sST2, and urinary cGMP at baseline, 1, 2 (sST2, cGMP), 4, and 8 weeks (n = 694 with all baseline biomarkers). Ratios of geometric means (timepoint/baseline) were determined and compared as a ratio for sacubitril/valsartan vs. enalapril. Compared with enalapril, sacubitril/valsartan led to a significantly greater decline in hsTnT and sST2. This effect emerged as early as 1 week for sST2 and was significant for both at 4 weeks with a 16% greater reduction in hsTnT (P < 0.001) and 9% greater reduction in sST2 (P = 0.0033). Serial urinary cGMP increased with sacubitril/valsartan compared with enalapril (P < 0.001, 1 week). The significant differences between treatment groups for each biomarker were sustained at 8 weeks. In an exploratory multivariable-adjusted analysis of cardiovascular death or HF-rehospitalization, the concentrations of hsTnT, sST2 at week 1 were significantly associated with subsequent outcome. Conclusion Biomarkers of myocardial stress are elevated in patients with ADHF and associated with outcome. Compared with enalapril, sacubitril/valsartan reduces myocardial injury and haemodynamic stress as reflected by biomarkers, with an onset that is apparent within 1–4 weeks. Clinical trials registration NCT 02554890 clinical.trials.gov

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