scholarly journals Rationale and design of the preserved versus reduced ejection fraction biomarker registry and precision medicine database for ambulatory patients with heart failure (PREFER-HF) study

Open Heart ◽  
2021 ◽  
Vol 8 (2) ◽  
pp. e001704
Author(s):  
Andrew Abboud ◽  
Austin Nguonly ◽  
Asher Bean ◽  
Kemar J Brown ◽  
Roy F Chen ◽  
...  

IntroductionPatients with heart failure (HF) are classically categorised by left ventricular ejection fraction (LVEF). Efforts to predict outcomes and response to specific therapy among LVEF-based groups may be suboptimal, in part due to the underlying heterogeneity within clinical HF phenotypes. A multidimensional characterisation of ambulatory patients with and without HF across LVEF groups is needed to better understand and manage patients with HF in a more precise manner.Methods and analysisTo date, the first cohort of 1313 out of total planned 3000 patients with and without HF has been enroled in this single-centre, longitudinal observational cohort study. Baseline and 1-year follow-up blood samples and clinical characteristics, the presence and duration of comorbidities, serial laboratory, echocardiographic data and images and therapy information will be obtained. HF diagnosis, aetiology of disease, symptom onset and clinical outcomes at 1 and 5 years will be adjudicated by a team of clinicians. Clinical outcomes of interest include all-cause mortality, cardiovascular mortality, all-cause hospitalisation, cardiovascular hospitalisation, HF hospitalisation, right-sided HF and acute kidney injury. Results from the Preserved versus Reduced Ejection Fraction Biomarker Registry and Precision Medicine Database for Ambulatory Patients with Heart Failure (PREFER-HF) trial will examine longitudinal clinical characteristics, proteomic, metabolomic, genomic and imaging data to better understand HF phenotypes, with the ultimate goal of improving precision medicine and clinical outcomes for patients with HF.Ethics and disseminationInformation gathered in this research will be published in peer-reviewed journals. Written informed consent for PREFER-HF was obtained from all participants. All study procedures were approved by the Mass General Brigham Institutional Review Board in Boston, Massachusetts and performed in accordance with the Declaration of Helsinki (Protocol Number: 2016P000339).Trial registration numberPREFER-HF ClinicalTrials.gov identifier: NCT03480633.

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
M Masuda ◽  
T Kanda ◽  
M Asai ◽  
T Mano ◽  
T Yamada ◽  
...  

Abstract Background The presence of atrial fibrillation (AF) has been demonstrated to be associated with poor clinical outcomes in heart failure patients with reduced ejection fraction. Objective This study aimed to elucidate the impact of the presence of atrial fibrillation (AF) on the clinical characteristics, therapeutics, and outcomes in patients with heart failure and preserved ejection fraction (HFpEF). Methods PURSUIT-HFpEF is a multicenter prospective observational study including patients hospitalized for acute heart failure with left ventricular ejection fraction of >50%. Patients with acute coronary syndrome or severe valvular disease were excluded. Results Of 486 HFpEF patients (age, 80.8±9.0 years old; male, 47%) from 24 cardiovascular centers, 199 (41%) had AF on admission. Patients with AF had lower systolic blood pressures (142±27 vs. 155±35mmHg, p<0.0001) and higher heart rates (91±29 vs. 82±26bpm, p<0.0001) than those without. There was no difference in the usage of inotropes or mechanical ventilation between the 2 groups. A higher quality of life score (EQ5D, 0.72±0.27 vs. 0.63±0.30, p=0.002) was observed at discharge in patients with than without AF. In addition, AF patients tended to demonstrate lower in-hospital mortality rates (0.5% vs. 2.4%, p=0.09) and shorter hospital stays (20.3±12.1 vs. 22.6±18.4 days, p=0.09) than those without. During a mean follow up of 360±111 days, mortality (14.1% vs. 15.3) and heart failure re-hospitalization rates (13.1% vs. 13.9%) were comparable between the 2 groups. Conclusion In contrast to heart failure patients with reduced ejection fraction, AF on admission was not associated with poor long-term clinical outcomes among HFpEF patients. Several in-hospital outcomes were better in patients with AF than in those without. Acknowledgement/Funding None


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Hyue Mee Kim ◽  
In-Chang Hwang ◽  
Wonsuk Choi ◽  
Yeonyee E. Yoon ◽  
Goo-Yeong Cho

AbstractAngiotensin receptor-neprilysin inhibitor (ARNI) and sodium–glucose co-transporter-2 inhibitor (SGLT2i) have shown benefits in diabetic patients with heart failure with reduced ejection fraction (HFrEF). However, their combined effect has not been revealed. We retrospectively identified diabetic patients with HFrEF who were prescribed an ARNI and/or SGLT2i. The patients were divided into groups treated with both ARNI and SGLT2i (group 1), ARNI but not SGLT2i (group 2), SGLT2i but not ARNI (group 3), and neither ARNI nor SGLT2i (group 4). After propensity score-matching, the occurrence of hospitalization for heart failure (HHF), cardiovascular mortality, and changes in echocardiographic parameters were analyzed. Of the 206 matched patients, 92 (44.7%) had to undergo HHF and 43 (20.9%) died of cardiovascular causes during a median 27.6 months of follow-up. Patients in group 1 exhibited a lower risk of HHF and cardiovascular mortality compared to those in the other groups. Improvements in the left ventricular ejection fraction and E/e′ were more pronounced in group 1 than in groups 2, 3 and 4. These echocardiographic improvements were more prominent after the initiation of ARNI, compare to the initiation of SGLT2i. In diabetic patients with HFrEF, combination of ARNI and SGT2i showed significant improvement in cardiac function and prognosis. ARNI-SGLT2i combination therapy may improve the clinical course of HFrEF in diabetic patients.


2020 ◽  
Vol 13 (7) ◽  
Author(s):  
Adam D. DeVore ◽  
Anne S. Hellkamp ◽  
Laine Thomas ◽  
Nancy M. Albert ◽  
Javed Butler ◽  
...  

Background: Among patients with heart failure (HF) with reduced ejection fraction (EF), improvements in left ventricular EF (LVEF) are associated with better outcomes and remain an important treatment goal. Patient factors associated with LVEF improvement in routine clinical practice have not been clearly defined. Methods: CHAMP-HF (Change the Management of Patients with Heart Failure) is a prospective registry of outpatients with HF with reduced EF. Assessments of LVEF are recorded when performed for routine care. We analyzed patients with both baseline and ≥1 follow-up LVEF assessments to describe factors associated with LVEF improvement. Results: In CHAMP-HF, 2623 patients had a baseline and follow-up LVEF assessment. The median age was 67 (interquartile range, 58–75) years, 40% had an ischemic cardiomyopathy, and median HF duration was 2.8 years (0.7–6.8). Median LVEF was 30% (23–35), and median change on follow-up was 4% (−2 to −13); 19% of patients had a decrease in LVEF, 31% had no change, 49% had a ≥5% increase, and 34% had a ≥10% increase. In a multivariable model, the following factors were associated with ≥5% LVEF increase: shorter HF duration (odds ratio [OR], 1.21 [95% CI, 1.17–1.25]), no implantable cardioverter defibrillator (OR, 1.46 [95% CI, 1.34–1.55]), lower LVEF (OR, 1.15 [95% CI, 1.10–1.19]), nonischemic cardiomyopathy (OR, 1.24 [95% CI, 1.09–1.36]), and no coronary disease (OR, 1.20 [95% CI, 1.03–1.35]). Conclusions: In a large cohort of outpatients with chronic HF with reduced EF, improvements in LVEF were common. Common baseline cardiac characteristics identified a population that was more likely to respond over time. These data may inform clinical decision making and should be the basis for future research on myocardial recovery.


Angiology ◽  
2020 ◽  
Vol 71 (5) ◽  
pp. 431-437
Author(s):  
Mohammad Zubaid ◽  
Wafa Rashed ◽  
Mustafa Ridha ◽  
Nooshin Bazargani ◽  
Adel Hamad ◽  
...  

We describe the characteristics of ambulatory patients with heart failure with reduced ejection fraction (HFrEF) in the Gulf region (Middle East) and the implementation of guideline-recommended treatments. We included 2427 HFrEF outpatients (mean age 59 ± 13 years, 75% males and median left ventricular ejection fraction [LVEF] of 30%). A high proportion of patients received guideline-recommended medications (angiotensin-converting enzyme inhibitor [ACEI]/angiotensin receptor blocker [ARB]/angiotensin receptor-neprilysin inhibitor [ARNI] 87%, β-blocker 91%, mineralocorticoid antagonist [MRA] 64%). However, only a minority of patients received guideline-recommended target doses (ACEI/ARB/ARNI 13%, β-blocker 27%, and MRA 4.4%). Old age was a significant independent predictor for not prescribing treatment ( P < .001 for ACEI/ARB/ARNI and MRA; and P = .002 for β-blockers). Other independent predictors were chronic kidney disease (for both ACEI/ARB/ARNI and MRA, P < .001) and higher LVEF ( P = .014 for β-blockers and P < .001 for MRA). Patients with HFrEF managed by heart failure specialists more often received recommended target doses of ACEI/ARB/ARNI (40% vs 11%, P < .001) and β-blockers (56% vs 26%, P < .001) compared to those treated by general cardiologists. Although the majority of our patients with HFrEF received guideline-recommended medications, the doses they were prescribed were suboptimal. Understanding the reasons behind this is important for improved practice.


Circulation ◽  
2018 ◽  
Vol 138 (Suppl_1) ◽  
Author(s):  
Carlos A Godoy Rivas ◽  
Samuel Urrutia ◽  
Eleazar Montalvan ◽  
Mario Rodriguez ◽  
Eduardo Venegas ◽  
...  

Introduction: Heart Failure (HF) is categorized according to the AHA/ACC 2013 HF Guidelines based on Left Ventricular Ejection Fraction (LVEF); HF with Reduced Ejection Fraction (HFrEF, EF≤40%), and HF with preserved EF (HFpEF, EF ≥ 50%). There is a group of “borderline” patients with EF 41%-49%, termed Heart Failure with Mid-Range Ejection Fraction (HFmrEF). Given this category is not well understood, we sought to evaluate clinical characteristics and management patterns for patients with HFmrEF. Methods: A systematic review was performed using Ovid MEDLINE, EMBASE, Cochrane CENTRAL and LILACS (1946 – 03/2018). Search terms included HF, mid-range, borderline LVEF with several ranges (40-50 or 40-45 or 45-50). Variables characterizing clinical features and medications were extracted for each HF group and adjusted odds ratios (ORs) were pooled. Results: Of 1,131 abstracts identified, 24 met inclusion criteria (total patients 480,188). Patients with HFmrEF compared to those with HFrEF were more likely to be female (OR 1.42), have hypertension [HTN] (OR 1.34) and diabetes (OR 1.11), higher SBP (OR 1.17), better NYHA-FC (FC I OR 1.73, FC II 1.33), less likely to have coronary artery disease [CAD] (OR 0.74) and more likely to be treated with ACEI, ARB, BB, Digoxin, MRA and statins (Figure 1-2). HFmrEF patients when compared to those with HFpEF were less likely to be female (OR 0.54) or have HTN (OR 0.68), and more likely to have CAD (OR 1.25), and to be treated with HF medications and statins. Conclusions: Patients with HFmrEF have higher SBP and better NYHA-FC (I and II) compared to HFrEF patients and are less likely to be female and more likely to have CAD compared to HFpEF patients. Further research is needed to help guide management in this unique but clinically important population. Figure 1A. Forest plot of adjusted ORs comparing baseline clinical characteristics of HFrEF vs HFmrEF patients Figure 1B. Forest plot of adjusted ORs comparing baseline clinical characteristics of HFmrEF vs HFpEF patients Figure 2A. Forest plot of adjusted ORs comparing medications used in HFrEF vs HFmrEF patients Figure 2B. Forest plot of adjusted ORs comparing medications used in HFmrEF vs HFpEF patients


Cardiology ◽  
2021 ◽  
pp. 1-6
Author(s):  
Sérgio Maltês ◽  
Gonçalo J.L. Cunha ◽  
Bruno M.L. Rocha ◽  
João Presume ◽  
Renato Guerreiro ◽  
...  

<b><i>Background:</i></b> In patients with heart failure (HF) and reduced ejection fraction (HFrEF) with or without type 2 diabetes mellitus, the sodium-glucose cotransporter 2 inhibitor (SGLT2i) dapagliflozin was recently shown to reduce the risk of worsening HF or death from cardiovascular causes in the dapagliflozin in patients with heart failure and reduced ejection fraction (DAPA-HF) trial. Our goal was to investigate how many patients in a real-world setting would be eligible for dapagliflozin according to the DAPA-HF enrolment criteria. <b><i>Methods:</i></b> This is a single-center retrospective study enrolling consecutive, unselected patients followed up in an HF clinic from 2013 to 2019. Key DAPA-HF inclusion criteria (i.e., left ventricular ejection fraction [LVEF] ≤40% and NT-proBNP ≥600 pg/mL [or ≥900 pg/mL if atrial fibrillation]) and exclusion criteria (estimated glomerular filtration rate [eGFR] &#x3c;30 mL/kg/1.73 m<sup>2</sup> and systolic blood pressure [SBP] &#x3c;95 mm Hg) were considered. <b><i>Results:</i></b> Overall, 479 patients (age 76 ± 13 years; 50.5% male; 78.9% hypertensive; 45.1% with an eGFR &#x3c;60 mL/min/1.73 m<sup>2</sup>; 36.5% with TD2M; and 33.5% with ischaemic HF) were assessed. The median SBP was 128.5 (112.0–146.0) mm Hg, mean eGFR was 50.8 ± 23.7 mL/min/1.73 m<sup>2</sup>, and median NT-proBNP was 2,183 (IQR 1,010–5,310) pg/mL. Overall, 155 (32.4%) patients had LVEF ≤40%. According to the DAPA-HF trial key criteria, 90 patients (18.8%) would be eligible for dapagliflozin. The remainder would be excluded due to LVEF &#x3e;40% (67.6%), eGFR &#x3c;30 mL/min/1.73 m<sup>2</sup> (19.4%), NT-proBNP below the cutoff (16.7%), and/or SBP &#x3c;95 mm Hg (6.5%). If we center the analysis to those with LVEF ≤40%, 58.1% would be eligible for dapagliflozin. The remainder would be excluded due to an eGFR &#x3c;30 mL/min/1.73 m<sup>2</sup> (20%), NT-proBNP below the cutoff (16.1%), and/or SBP &#x3c;95 mm Hg (8.4%). <b><i>Conclusion:</i></b> Roughly half of our real-world HFrEF cohort would be eligible for dapagliflozin according to the key criteria of the DAPA-HF trial. The main reason for non-eligibility was an eGFR &#x3c;30 mL/min/1.73 m<sup>2</sup>. However, two-thirds of patients had LVEF &#x3e;40%. These findings show that dapagliflozin is a promising complementary new drug in the therapeutic armamentarium of most patients with HFrEF, while highlighting the urgent need for disease-modifying drugs in mid-range and preserved LVEF and the need to assess the efficacy and safety of SLGT2i in advanced kidney disease patients. The results of ongoing SGLT2i trials in these LVEF subgroups are eagerly awaited.


2021 ◽  
Vol 23 (Supplement_G) ◽  
Author(s):  
Vincenzo De Marzo ◽  
Lucia Tricarico ◽  
Giuseppe Biondi Zoccai ◽  
Michele Correale ◽  
Natale Daniele Brunetti ◽  
...  

Abstract Aims We assessed the efficacy of add-on drugs in patients with heart failure with reduced ejection fraction (HFrEF) and concomitant chronic kidney disease (CKD) already receiving neurohormonal inhibition (NEUi). Methods and results The literature was systematically searched for phase 3 randomized controlled trials (RCTs) involving ≥90% patients with left ventricular ejection fraction &lt;45%, of whom &lt;30% were acutely decompensated, and with published information about the subgroup of estimated glomerular filtration rate &lt;60 ml/min/1.73 m2. Six RCTs were included in a study-level network meta-analysis evaluating the effect of NEUi, ivabradine, angiotensin receptor-neprilysin inhibitor (ARNI), sodium-glucose cotransporter-2 inhibitors (SGLT2i), vericiguat, and omecamtiv mecarbil (OM) on a composite outcome of cardiovascular death or hospitalization for heart failure. In a fixed-effects model, SGLT2i (HR: 0.78, 95% CrI: 0.69–0.89), ARNI (HR: 0.79, 95% CrI: 0.69–0.90), and ivabradine (HR: 0.82, 95% CrI: 0.69–0.98) decreased the risk of the composite outcome vs. NEUi, whereas OM did not (HR: 0.98, 95% CrI: 0.89–1.10). A trend for improved outcome was also found for vericiguat (HR: 0.90, 95% CrI: 0.80–1.00). In indirect comparisons, both SLGT2i (HR: 0.80, 95% CrI: 0.68–0.94) and ARNI (HR: 0.80, 95% CrI: 0.68–0.95) reduced the risk vs. OM; furthermore, there was a trend for a greater benefit of SGLT2i vs. vericiguat (HR: 0.88, 95% CrI: 0.73–1.00) and ivabradine vs. OM (HR: 0.84, 95% CrI: 0.68–1.00). Results were comparable in a random-effects model and in sensitivity analyses. SUCRA scores were 81.8%, 80.8%, 68.9%, 44.2%, 16.6%, and 7.8% for SGLT2i, ARNI, ivabradine, vericiguat, OM, and NEUi, respectively. Conclusions Expanding pharmacotherapy beyond NEUi improves outcomes in HFrEF with CKD. 633 Figure


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