scholarly journals Hemoglobin and Clinical Outcomes in the VerICiguaT Global Study in Patients With Heart Failure and Reduced Ejection Fraction (VICTORIA)

Author(s):  
Justin A. Ezekowitz ◽  
Yinggan Zheng ◽  
Alain Cohen-Solal ◽  
Vojtěch Melenovský ◽  
Jorge Escobedo ◽  
...  

Background: In the VICTORIA trial, anemia occurred more often in patients treated with vericiguat (7.6%) than placebo (5.7%). We explored the association between vericiguat, randomization hemoglobin, development of anemia and whether the benefit of vericiguat related to baseline hemoglobin. Methods: Anemia was defined as hemoglobin <13.0 g/dL in men and <12.0 g/dL in women (World Health Organization [WHO] Anemia). Adverse events (AEs) reported as anemia were also evaluated. We assessed the risk-adjusted relationship between hemoglobin and hematocrit with the primary outcome (composite of cardiovascular death or heart failure hospitalization), and the time-updated hemoglobin relationship to outcomes. Results: At baseline, 1719 (35.7%) had WHO anemia; median hemoglobin was 13.4 g/L (25th, 75th percentile: 12.1, 14.7 g/dL). At 16 weeks from randomization, 1643 patients had WHO anemia (284 new for vericiguat and 219 for placebo), which occurred more often with vericiguat than placebo (p<0.001). After 16 weeks, no further decline in hemoglobin occurred over 96 weeks of follow-up and the ratio of hemoglobin/hematocrit remained constant. Overall, AE anemia occurred in 342 patients (7.1%). A lower hemoglobin was unrelated to the treatment benefit of vericiguat (vs. placebo) on the primary outcome. Additionally, analysis of time-updated hemoglobin revealed no association with the treatment effect of vericiguat (vs. placebo) on the primary outcome. Conclusions: Anemia was common at randomization and lower hemoglobin was associated with a greater frequency of clinical events. Although vericiguat modestly lowered hemoglobin by 16 weeks, this effect did not further progress nor was it related to the treatment benefit of vericiguat. Clinical Trial Registration: Clinical Trials.gov (NCT02861534)

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Kieran Docherty ◽  
Silvio E Inzucchi ◽  
Lars Kober ◽  
Mikhail Kosiborod ◽  
Anna Maria Langkilde ◽  
...  

Background: Anemia is common and associated with worse outcomes in patients with heart failure and reduced ejection fraction (HFrEF). We examined: 1) whether dapagliflozin corrected anemia in these patients, and 2) the effect of dapagliflozin on outcomes, in patients with or without anemia, in DAPA-HF. Methods: Anemia was defined as baseline hematocrit <39% in men and <36% in women (WHO). Correction of anemia was defined as two consecutive hematocrit measurements above these thresholds at any time during follow-up (follow-up visits: 2 weeks, 2 and 4 months and 4-monthly thereafter). The primary outcome was a composite of worsening HF (hospitalization or urgent visit requiring intravenous therapy) or cardiovascular death. Findings: Of the 4744 patients randomized in DAPA-HF, 4691 had a baseline hematocrit and 1032 were anemic (22.0%). Anemia was corrected in 62% of patients in the dapagliflozin group, compared with 41% of patients in the placebo group (odds ratio 2.37 [95% CI 1.84-3.04]; p<0.001). The effect of dapagliflozin on the primary outcome was consistent in anemic and non-anemic patients (HR 0.68 [95% CI 0.52-0.88] versus 0.76 [0.65-0.89]; P-interaction=0.44) [Figure]. A consistent benefit was also observed for the secondary outcomes, irrespective of anemia status t baseline. Patients with resolution of anemia had better outcomes than those with persisting anemia: rate of primary outcome 9.9 per 100 patient-years (95% CI 8.0-12.4) in those with resolution versus 24.1 per 100 patient-years (20.4-28.3) in those without anemia resolution. Interpretation: Anemia was common in patients in DAPA-HF and associated with worse outcomes. Resolution of anemia was associated with better outcomes than persistence of anemia, regardless of treatment allocation. Although dapagliflozin corrected anemia more often than placebo, treatment with dapagliflozin improved outcomes, irrespective of anemia status.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
H J Kim ◽  
M A Kim ◽  
D I Lee ◽  
H L Kim ◽  
D J Choi ◽  
...  

Abstract Background Ischemic heart disease (IHD) is a major underlying etiology in patients with heart failure (HF). Although the impact of IHD on HF is evolving, there is a lack of understanding of how IHD affects long-term clinical outcomes and uncertainty about the role of IHD in determining the risk of clinical outcomes by gender. Purpose This study aims to evaluate the gender difference in impact of IHD on long-term clinical outcomes in patients with heart failure reduced ejection fraction (HFrEF). Methods Study data were obtained from the nationwide registry which is a prospective multicenter cohort and included patients who were hospitalized for HF composed of 3,200 patients. A total of 1,638 patients with HFrEF were classified into gender (women 704 and men 934). The primary outcome was all-cause death during follow-up and the composite clinical events of all-cause death and HF readmission during follow-up were also obtained. HF readmission was defined as re-hospitalization because of HF exacerbation. Results 133 women (18.9%) were died and 168 men (18.0%) were died during follow-up (median 489 days; inter-quartile range, 162–947 days). As underlying cause of HF, IHD did not show significant difference between genders. Women with HFrEF combined with IHD had significantly lower cumulative survival rate than women without IHD at long-term follow-up (74.8% vs. 84.9%, Log Rank p=0.001, Figure 1). However, men with HFrEF combined with IHD had no significant difference in survival rate compared with men without IHD (79.3% vs. 83.8%, Log Rank p=0.067). After adjustment for confounding factors, Cox regression analysis showed that IHD had a 1.43-fold increased risk for all-cause mortality independently only in women. (odds ratio 1.43, 95% confidence interval 1.058–1.929, p=0.020). On the contrary to the death-free survival rates, there were significant differences in composite clinical events-free survival rates between patients with HFrEF combined with IHD and HFrEF without IHD in both genders. Figure 1 Conclusions IHD as predisposing cause of HF was an important risk factor for long-term mortality in women with HFrEF. Clinician need to aware of gender-based characteristics in patients with HF and should manage and monitor them appropriately and gender-specifically. Women with HF caused by IHD also should be treated more meticulously to avoid a poor prognosis. Acknowledgement/Funding None


Author(s):  
Faiez Zannad ◽  
João Pedro Ferreira ◽  
Stuart J. Pocock ◽  
Cordula Zeller ◽  
Stefan D. Anker ◽  
...  

Background: In EMPEROR-Reduced, empagliflozin reduced cardiovascular death or HF hospitalization, total HF hospitalizations, and slowed the progressive decline in kidney function in patients with HF and a reduced ejection fraction (HFrEF), with and without diabetes. We aim to study the effect of empagliflozin on cardiovascular and kidney outcomes across the spectrum of kidney function. Methods: In this pre-specified analysis, patients were categorized by the presence or absence of CKD at baseline (eGFR<60ml/min/1.73m 2 or UACR>300mg/g). The primary and key secondary outcomes were (1) a composite of cardiovascular death or HF hospitalization (primary outcome); (2) total HF hospitalizations, and (3) eGFR slope. The direct impact on kidney events was investigated by a prespecified composite kidney outcome (defined as a sustained profound decline in eGFR, chronic dialysis or transplant). The median follow-up was 16 months. Results: 3730 patients were randomized to empagliflozin or placebo, of whom 1978 (53%) had CKD. Empagliflozin reduced the primary outcome and total HF hospitalizations in patients with and without CKD: primary outcome HR=0.78 (95%CI=0.65-0.93) and HR=0.72 (95%CI=0.58-0.90), respectively; interaction P=0.63. Empagliflozin slowed the slope of eGFR decline by 1.11 (0.23-1.98) ml/min/1.73m 2 /year in patients with CKD and by 2.41 (1.49-3.32) ml/min/1.73m2/year in patients without CKD. The risk of the composite kidney outcome was reduced similarly in patients with and without CKD: HR=0.53 (95%CI=0.31-0.91) and HR=0.46 (95%CI=0.22-0.99), respectively. The effect of empagliflozin on the primary composite outcome and the key secondary outcomes was consistent across a broad range of baseline kidney function, measured by clinically relevant eGFR subgroups or by albuminuria, including patients with eGFR as low as 20 ml/min/1.73m 2 . Empagliflozin was well tolerated in CKD patients. Conclusions: In EMPEROR-reduced, empagliflozin had a beneficial effect on the key efficacy outcomes and slowed the rate of kidney function decline in patients with and without CKD and regardless of the severity of kidney impairment at baseline. Clinical Trial Registration: URL: https://clinicaltrials.gov Unique Identifier: NCT03057977


2017 ◽  
Vol 32 (2) ◽  
pp. 158-162
Author(s):  
Eric R. Sparks ◽  
Janna C. Beavers

Objective: To evaluate the impact of a pharmacist-driven initiative to optimize aldosterone antagonist use in patients with heart failure with reduced ejection fraction (HFrEF) at a large community hospital. Methods: This single-center, retrospective cohort study compared patients with heart failure before and after the implementation of the initiative. Data for pre- and postinitiative patients were retrospectively collected to assess patient characteristics and aldosterone antagonist use. The primary outcome was a composite of eligible patients with heart failure discharged on aldosterone antagonist therapy or with a documented reason for ineligibility before and after commencement of pharmacist-driven aldosterone antagonist initiative. Results: The preinitiative cohort included 96 patients and the postinitiative cohort contained 92 patients. When the 3 month pre- and postinitiative groups were assessed, the primary outcome was noted in 60 (63%) of 96 patients in the preinitiative group and 87 (95%) of 92 patients in the postinitiative group ( P < .0001). Conclusion: In patients with HFrEF, a pharmacist-driven aldosterone antagonist optimization initiative significantly increased appropriate prescribing and documentation for aldosterone antagonist therapy.


2021 ◽  
Vol 10 (4) ◽  
Author(s):  
Solmaz Ehteshami‐Afshar ◽  
Leanne Mooney ◽  
Pooja Dewan ◽  
Akshay S. Desai ◽  
Ninian N. Lang ◽  
...  

Background Chronic obstructive pulmonary disease (COPD) is a common comorbidity in heart failure with reduced ejection fraction, associated with undertreatment and worse outcomes. New treatments for heart failure with reduced ejection fraction may be particularly important in patients with concomitant COPD. Methods and Results We examined outcomes in 8399 patients with heart failure with reduced ejection fraction, according to COPD status, in the PARADIGM‐HF (Prospective Comparison of Angiotensin Receptor Blocker–Neprilysin Inhibitor With Angiotensin‐Converting Enzyme Inhibitor to Determine Impact on Global Mortality and Morbidity in Heart Failure) trial. Cox regression models were used to compare COPD versus non‐COPD subgroups and the effects of sacubitril/valsartan versus enalapril. Patients with COPD (n=1080, 12.9%) were older than patients without COPD (mean 67 versus 63 years; P <0.001), with similar left ventricular ejection fraction (29.9% versus 29.4%), but higher NT‐proBNP (N‐terminal pro‐B‐type natriuretic peptide; median, 1741 pg/mL versus 1591 pg/mL; P=0.01), worse functional class (New York Heart Association III/IV 37% versus 23%; P <0.001) and Kansas City Cardiomyopathy Questionnaire–Clinical Summary Score (73 versus 81; P <0.001), and more congestion and comorbidity. Medical therapy was similar in patients with and without COPD except for beta‐blockade (87% versus 94%; P <0.001) and diuretics (85% versus 80%; P <0.001). After multivariable adjustment, COPD was associated with higher risks of heart failure hospitalization (hazard ratio [HR], 1.32; 95% CI, 1.13–1.54), and the composite of cardiovascular death or heart failure hospitalization (HR, 1.18; 95% CI, 1.05–1.34), but not cardiovascular death (HR, 1.10; 95% CI, 0.94–1.30), or all‐cause mortality (HR, 1.14; 95% CI, 0.99–1.31). COPD was also associated with higher risk of all cardiovascular hospitalization (HR, 1.17; 95% CI, 1.05–1.31) and noncardiovascular hospitalization (HR, 1.45; 95% CI, 1.29–1.64). The benefit of sacubitril/valsartan over enalapril was consistent in patients with and without COPD for all end points. Conclusions In PARADIGM‐HF, COPD was associated with lower use of beta‐blockers and worse health status and was an independent predictor of cardiovascular and noncardiovascular hospitalization. Sacubitril/valsartan was beneficial in this high‐risk subgroup. Registration URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01035255.


PLoS ONE ◽  
2021 ◽  
Vol 16 (3) ◽  
pp. e0249043
Author(s):  
Sarinya Puwanant ◽  
Supanee Sinphurmsukskul ◽  
Laddawan Krailak ◽  
Pavinee Nakaviroj ◽  
Noppawan Boonbumrong ◽  
...  

Background We sought to investigate the impact of the COVID-19 pandemic and the Tele-HF Clinic (Tele-HFC) program on cardiovascular death, heart failure (HF) rehospitalization, and heart transplantation rates in a cohort of ambulatory HF patients during and after the peak of the pandemic. Methods Using the HF clinic database, we compared data of patients with HF before, during, and after the peak of the pandemic (January 1 to March 17 [pre-COVID], March 17 to May 31 [peak-COVID], and June 1 to October 1 [post-COVID]). During peak-COVID, all patients were managed by Tele-HFC or hospitalization. After June 1, patients chose either a face-to-face clinic visit or a continuous tele-clinic visit. Results Cardiovascular death and medical titration rates were similar in peak-COVID compared with all other periods. HF readmission rates were significantly lower in peak-COVID (8.7% vs. 2.5%, p<0.001) and slightly increased (3.5%) post-COVID. Heart transplant rates were substantially increased in post-COVID (4.5% vs. peak-COVID [0%], p = 0.002). After June 1, 38% of patients continued with the Tele-HFC program. Patients managed by the Tele-HFC program for <6 months were less likely to have HF with reduced ejection fraction (73% vs. 54%, p = 0.005) and stage-D HF (33% vs. 14%, p = 0.001), and more likely to achieve the target neurohormonal blockade dose (p<0.01), compared with the ≥6-month Tele-HFC group. Conclusions HF rehospitalization and transplant rates significantly declined during the pandemic in ambulatory care of HF. However, reduction in these rates did not affect subsequent 5-month hospitalization and cardiovascular mortality in the setting of Tele-HFC program and continuum of advanced HF therapies.


2016 ◽  
Vol 02 (01) ◽  
pp. 14 ◽  
Author(s):  
José Silva Cardoso ◽  

This editorial summarises important findings from the PARADIGM-HF study. PARADIGM-HF indicated that the angiotensin receptorneprilysin inhibitor, LCZ696, is superior to enalapril in reducing the risks of cardiovascular death and of hospitalisation for heart failure in patients with heart failure and reduced ejection fraction.


Author(s):  
Eun Young Kim ◽  
Youn-Jung Son

Cognitive impairment is more prevalent in heart failure (HF) patients. Anemia can influence cognitive ability and is likely more prevalent in elderly patients with HF. However, there are limited data on the association of anemia with cognitive impairment in elderly HF patients. This study aimed to identify the association between anemia and cognitive impairment in elderly HF patients. This secondary data analysis included 181 patients aged 60 years or older with HF. Patients were categorized into an anemic or non-anemic group based on World Health Organization (WHO) criteria. We assessed the cognitive function using the Modified Mini-Mental State (3MS) at the time of enrollment. The prevalence of anemia and cognitive impairment in older patients with HF was the same at 35.4%. The main finding of the multiple logistic regression indicated that compared to a non-anemic status, anemia increased the risk of cognitive impairment (odds ratio (OR) = 4.268, 95% confidence interval (CI) = 1.898–9.593, p < 0.001). Healthcare providers should recognize the value of the significance of early assessment of anemic status and cognitive function following HF. A prospective cohort study should identify the pathway of the association between anemia and incidence of cognitive impairment.


2020 ◽  
Vol 25 (8) ◽  
pp. 4049
Author(s):  
N. R. Khasanov

SGLT2 inhibitors have been shown to reduce the risk of cardiovascular events and the development and decompensation of heart failure (HF) in patients with type 2 diabetes (T2D). The improved prognosis in HF may be related not only to the hypoglycemic effect of this drug class. The DAPA-HF study, which included patients with HF with reduced ejection fraction, demonstrated the benefit of dapagliflozin in reducing the risk of cardiovascular death and worsening HF, as well as improving HF symptoms compared to placebo, regardless of the presence of T2D and the recommended therapy for HF.


Sign in / Sign up

Export Citation Format

Share Document