Improving female enrolment in randomized clinical trials of heart failure with reduced ejection fraction to ensure evidence‐based health care recommendations

2021 ◽  
Author(s):  
Birke Schneider ◽  
Peter Ong
Keyword(s):  
Heart Failure ◽  
Health Care ◽  
Clinical Trials ◽  
Ejection Fraction ◽  
Randomized Clinical Trials ◽  
Evidence Based ◽  
Reduced Ejection Fraction ◽  
Evidence Based Health Care

scholarly journals 480 Catheter pulmonary vein ablation vs. medical therapy or atrioventricular node ablation and resynchronization in patients with atrial fibrillation and heart failure: a systematic review and meta-analysis

2021 ◽  
Vol 23 (Supplement_G) ◽  
Author(s):  
Gaetano Liccardo ◽  
Francesco Cannata ◽  
Mauro Chiarito ◽  
Sara Bombace ◽  
Marta Maccallini ◽  
...  
Keyword(s):  
Heart Failure ◽  
Atrial Fibrillation ◽  
Clinical Trials ◽  
Catheter Ablation ◽  
Ejection Fraction ◽  
Pulmonary Vein ◽  
Medical Therapy ◽  
Randomized Clinical Trials ◽  
Atrioventricular Node ◽  
Reduced Ejection Fraction

Abstract Aims Atrial fibrillation (AF) and heart failure (HF) are increasing in prevalence worldwide and, when present altogether, are associated with significant mortality and morbidity. Several and recent randomized clinical trials have reported an improvement of clinical outcomes in patients with HF and AF with catheter ablation. To provide a comprehensive and updated synthesis of effect estimates of the available randomized and observational clinical trials comparing pulmonary vein isolation with optimal medical therapy (rate or rhythm) or atrioventricular node ablation and resynchronization. Methods and results MEDLINE database was searched from inception to 4 March 2021 by two reviewers (F.C. and M.C.) for relevant studies. The following key words were used: ‘atrial fibrillation’, ‘heart failure’, ‘ablation’, ‘medical’, ‘drug’, ‘rate’, ‘rhythm’, ‘resynchronization’, and ‘atrial flutter’. The co-primary outcomes were all-cause death and hospitalization for HF. A total of 16 studies enrolling 42 908 patients were included; of these, 9 were randomized controlled trials, 3 unadjusted observational studies, and 4 adjusted observational trials. Patients treated with catheter ablation had a statistically significant reduction for the risk of all-cause death {Figure on the left: odds ratio [OR]: 0.51, [95% confidence interval (CI): 0.31–0.84], P = 0.008, NNT 33} and hospitalization for HF [Figure on the right: OR: 0.52, (95% CI: 0.31–0.87), P 0.014, NNT 24]. Subgroup analysis confirmed these results only in HF with reduced ejection fraction subgroup. Meta-regression analyses showed a direct correlation between a higher burden of persistent/long-standing persistent AF and the positive impact of catheter ablation of AF. Moreover, the age of 70 years emerged as the cut-off age for a greater impact of catheter ablation. Conclusions Catheter ablation of AF is associated with a lower risk of all-cause death and HF hospitalizations in patients with AF and HF, as compared to medical therapy or atrioventricular node ablation and resynchronization. These results are mainly applicable for HF with reduced ejection fraction.

Representation of black patients in randomized clinical trials of heart failure with reduced ejection fraction

2018 ◽  
Vol 197 ◽  
pp. 43-52 ◽  
Author(s):  
Lonnie T. Sullivan ◽  
Tiffany Randolph ◽  
Peter Merrill ◽  
Larry R. Jackson ◽  
Chidiebube Egwim ◽  
...  
Keyword(s):  
Heart Failure ◽  
Clinical Trials ◽  
Ejection Fraction ◽  
Randomized Clinical Trials ◽  
Reduced Ejection Fraction ◽  
Black Patients

Abstract 2391: Impact of Therapies for Anemia on Outcomes in Patients with Heart Failure in Randomized Clinical Trials

Circulation ◽  
2008 ◽  
Vol 118 (suppl_18) ◽  
Author(s):  
Howard M Julien ◽  
Preetika Muthukrishnan ◽  
Eldrin F Lewis
Keyword(s):  
Heart Failure ◽  
Clinical Trials ◽  
Ejection Fraction ◽  
Serum Creatinine ◽  
Exercise Capacity ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
The Impact

Anemia is common in heart failure (HF) patients and has been well-established as a risk factor for increased risk of HF hospitalization and mortality. Treatment with erythropoietin stimulating agents (ESA) has increased hemoglobin, but outcomes trials are limited and use of ESA has been controversial given disparate results in other populations. This meta-analysis aimed to evaluate the impact of ESA and iron on outcomes in HF patients. A systematic review of four databases was conducted in April 2008 (n = 95 unique trials). Analysis inclusion criteria included randomized controlled trial to ESA/iron with clinically defined HF, yielding 10 eligible trials published between 6/01–3/08. Data was independently extracted and cross-checked for accuracy and reliability (2 investigators). A total of 768 subjects (421 treated and 338 controls) are included (Characteristics in Table 1 ). Randomization to ESA produced a significant improvement in exercise capacity 0.39 standard units [95% CI 0.1– 0.6, p = 0.001], a 5.72% [95% CI 1.2–10.3, p = 0.014] increase in left ventricle ejection fraction and a 0.23 mg/dL [95% CI 0.4 – 0.1 p = 0.001] reduction in serum creatinine. There was no difference in all-cause mortality - RR 0.79 [95% CI 0.49, 1.26, p = 0.320]. Trends were noted in reduced hospitalization rates, decreased brain natriuretic peptide, and improved quality of life. Meta-analysis of randomized studies of treatment of anemia in HF patients suggests significant benefit in exercise capacity, left ventricular ejection fraction, and serum creatinine. There does not appear to be excess mortality with ESA/iron treatment. Despite favorable findings, definitive randomized clinical trials are needed to assess the role of this treatment modality in HF management. Table 1. Baseline Patient and Study Characteristics

scholarly journals Treatment of Atrial Fibrillation in Patients with Co-existing Heart Failure and Reduced Ejection Fraction: Time to Revisit the Management Guidelines?

2018 ◽  
Vol 7 (2) ◽  
pp. 91 ◽  
Author(s):  
Alex Baher ◽  
Nassir F Marrouche ◽  
◽  
◽  
◽  
...  
Keyword(s):  
Heart Failure ◽  
Clinical Trials ◽  
Catheter Ablation ◽  
Ejection Fraction ◽  
Rhythm Control ◽  
Pharmacological Interventions ◽  
Reduced Ejection Fraction ◽  
Increased Risk ◽  
Patients With Heart Failure ◽  
Heart Failure Hospitalisation

AF in patients with heart failure and reduced ejection fraction (HFrEF) is common and is associated with an increased risk of stroke, heart failure hospitalisation and all-cause mortality. Rhythm control of AF in this population has been traditionally limited to the use of antiarrhythmic drugs. Clinical trials assessing superiority of pharmacological rhythm control over rate control have been largely disappointing. Catheter ablation has emerged as a viable alternative to pharmacological rhythm control in symptomatic AF and has enjoyed significant technological advancements over the past decade. Recent clinical trials have suggested that catheter ablation is superior to pharmacological interventions in patients with co-existing AF and HFrEF. In this article, we will review the therapeutic options for AF in patients with HFrEF in the context of the latest clinical trials beyond the current established guidelines.

scholarly journals The continuous heart failure spectrum: moving beyond an ejection fraction classification

2019 ◽  
Vol 40 (26) ◽  
pp. 2155-2163 ◽  
Author(s):  
Filippos Triposkiadis ◽  
Javed Butler ◽  
Francois M Abboud ◽  
Paul W Armstrong ◽  
Stamatis Adamopoulos ◽  
...  
Keyword(s):  
Heart Failure ◽  
Clinical Trials ◽  
Ejection Fraction ◽  
Statistical Power ◽  
Structural Changes ◽  
Randomized Clinical Trials ◽  
New Technologies ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Ventricular Ejection Fraction

Abstract Randomized clinical trials initially used heart failure (HF) patients with low left ventricular ejection fraction (LVEF) to select study populations with high risk to enhance statistical power. However, this use of LVEF in clinical trials has led to oversimplification of the scientific view of a complex syndrome. Descriptive terms such as ‘HFrEF’ (HF with reduced LVEF), ‘HFpEF’ (HF with preserved LVEF), and more recently ‘HFmrEF’ (HF with mid-range LVEF), assigned on arbitrary LVEF cut-off points, have gradually arisen as separate diseases, implying distinct pathophysiologies. In this article, based on pathophysiological reasoning, we challenge the paradigm of classifying HF according to LVEF. Instead, we propose that HF is a heterogeneous syndrome in which disease progression is associated with a dynamic evolution of functional and structural changes leading to unique disease trajectories creating a spectrum of phenotypes with overlapping and distinct characteristics. Moreover, we argue that by recognizing the spectral nature of the disease a novel stratification will arise from new technologies and scientific insights that will shape the design of future trials based on deeper understanding beyond the LVEF construct alone.

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