Natriuretic Peptides as Inclusion Criteria in Clinical Trials

Ibrahim, Nasrien E.; Burnett, John C.; Butler, Javed; Camacho, Alexander; Felker, G. Michael; Fiuzat, Mona; O’Connor, Christopher; Solomon, Scott D.; Vaduganathan, Muthiah; Zile, Michael R.; Januzzi, James L.

doi:10.1016/j.jchf.2019.12.010

Cited by 58 publications

(58 citation statements)

References 24 publications

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“…Further, information regarding the diagnostic and prognostic roles of biomarkers such as NT‐proBNP in this clinical context is lacking. Historically, studies such as TOPCAT 14 have supported the value of NT‐proBNP and it has in recent years played a growing role in the standardization of both the definition of HF and the inclusion criteria of major clinical trials 15 . This cardiac biomarker has proven useful for the diagnosis of AHF in patients presenting with dyspnoea and no previous history of HF, especially if other imaging techniques such as transthoracic echocardiography are not readily available 4 .…”

Section: Discussionmentioning

confidence: 99%

Heart failure in COVID‐19 patients: prevalence, incidence and prognostic implications

Rey

Caro‐Codón

Rosillo

et al. 2020

European J of Heart Fail

193

236

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Aims Data regarding impact of COVID‐19 in chronic heart failure (CHF) patients and its potential to trigger acute heart failure (AHF) is lacking. The aim of this work was to study characteristics, cardiovascular outcomes and mortality in patients with confirmed COVID‐19 infection and prior diagnosis of HF. Also, to identify predictors and prognostic implications for AHF decompensations during hospital admission and to determine whether there was a correlation between withdrawal of HF guideline‐directed medical therapy (GDMT) and worse outcomes during hospitalization. Methods and results A total of 3080 consecutive patients with confirmed COVID‐19 infection and at least 30‐day follow‐up were analyzed. Patients with previous history of CHF (152, 4.9%), were more prone to develop AHF (11.2% vs 2.1%; p<0.001) and had higher levels of NT‐proBNP. Also, previous CHF group had higher mortality rates (48.7% vs 19.0%; p<0.001). In contrast, 77 patients (2.5%) were diagnosed of AHF and the vast majority (77.9%) developed in patients without history of HF. Arrhythmias during hospital admission and CHF were main predictors of AHF. Patients developing AHF had significantly higher mortality (46.8% vs 19.7%; p<0.001). Finally, withdrawal of beta‐blockers, mineralocorticoid antagonists and ACE/ARB inhibitors was associated with a significant increase of in‐hospital mortality. Conclusions Patients with COVID‐19 have a significant incidence of AHF, entity that carries within a very high mortality. Moreover, patients with history of CHF are prone to develop acute decompensation after COVID‐19 diagnosis. Withdrawal of GDMT was associated with higher mortality.

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Section: Discussionmentioning

confidence: 99%

Heart failure in COVID‐19 patients: prevalence, incidence and prognostic implications

Rey

Caro‐Codón

Rosillo

et al. 2020

European J of Heart Fail

193

236

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“…We limited the number of patients who had an ejection fraction of more than 30% by requiring a history of hospitalization for heart failure within the previous 12 months or a particularly high level of N-terminal prohormone of brain natriuretic peptide (NT-proBNP), including a level of at least 1000 pg per milliliter in those with an ejection fraction of 31 to 35% or a level of at least 2500 pg per milliliter in those with an ejection fraction of 36 to 40%, as compared with a level of at least 600 pg per milliliter in those with an ejection fraction of 30% or less. 6 These NT-proBNP thresholds were doubled in patients with atrial fibrillation. 5 The key inclusion and exclusion criteria are provided in the Supplementary Appendix, available at NEJM.org.…”

Section: Patientsmentioning

confidence: 99%

Cardiovascular and Renal Outcomes with Empagliflozin in Heart Failure

et al. 2020

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BACKGROUND Sodium-glucose cotransporter 2 (SGLT2) inhibitors reduce the risk of hospitalization for heart failure in patients regardless of the presence or absence of diabetes. More evidence is needed regarding the effects of these drugs in patients across the broad spectrum of heart failure, including those with a markedly reduced ejection fraction. METHODS In this double-blind trial, we randomly assigned 3730 patients with class II, III, or IV heart failure and an ejection fraction of 40% or less to receive empagliflozin (10 mg once daily) or placebo, in addition to recommended therapy. The primary outcome was a composite of cardiovascular death or hospitalization for worsening heart failure. RESULTS During a median of 16 months, a primary outcome event occurred in 361 of 1863 patients (19.4%) in the empagliflozin group and in 462 of 1867 patients (24.7%) in the placebo group (hazard ratio for cardiovascular death or hospitalization for heart failure, 0.75; 95% confidence interval [CI], 0.65 to 0.86; P<0.001). The effect of empagliflozin on the primary outcome was consistent in patients regardless of the presence or absence of diabetes. The total number of hospitalizations for heart failure was lower in the empagliflozin group than in the placebo group (hazard ratio, 0.70; 95% CI, 0.58 to 0.85; P<0.001). The annual rate of decline in the estimated glomerular filtration rate was slower in the empagliflozin group than in the placebo group (-0.55 vs.-2.28 ml per minute per 1.73 m 2 of body-surface area per year, P<0.001), and empagliflozin-treated patients had a lower risk of serious renal outcomes. Uncomplicated genital tract infection was reported more frequently with empagliflozin. CONCLUSIONS Among patients receiving recommended therapy for heart failure, those in the empagliflozin group had a lower risk of cardiovascular death or hospitalization for heart failure than those in the placebo group, regardless of the presence or absence of diabetes. (Funded by Boehringer Ingelheim and Eli Lilly; EMPEROR-Reduced ClinicalTrials.gov number, NCT03057977.

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“…However, without NT-proBNP, the differentiation of acute heart failure from non-cardiac dyspnea might be less accurate. Moreover, the importance of using natriuretic peptides as inclusion criteria in clinical trials was recently proposed [ 63 ]. Thus, including patients without NT-proBNP results in statistical modeling might not be appropriate and may bias the results.…”

Section: Discussionmentioning

confidence: 99%

Clinical Predictors Influencing the Length of Stay in Emergency Department Patients Presenting with Acute Heart Failure

et al. 2020

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Background and objectives: Acute heart failure is a common problem encountered in the emergency department (ED). More than 80% of the patients with the condition subsequently require lengthy and repeated hospitalization. In a setting with limited in-patient capacity, the patient flow is often obstructed. Appropriate disposition decisions must be made by emergency physicians to deliver effective care and alleviate ED overcrowding. This study aimed to explore clinical predictors influencing the length of stay (LOS) in patients with acute heart failure who present to the ED. Materials and Methods: We conducted prognostic factor research with a retrospective cohort design. Medical records of patients with acute heart failure who presented to the ED of Ramathibodi Hospital from January to December 2015 were assessed for eligibility. Thirteen potential clinical predictors were selected as candidates for statistical modeling based on previous reports. Multivariable Poisson regression was used to estimate the difference in LOS between patients with and without potential predictors. Results: A total of 207 patients were included in the analysis. Most patients were male with a mean age of 74.2 ± 12.5 years. The median LOS was 54.6 h (Interquartile range 17.5, 149.3 h). From the multivariable analysis, four clinical characteristics were identified as independent predictors with an increase in LOS. These were patients with New York Heart Association (NYHA) functional class III/IV (+72.9 h, 95%Confidence interval (CI) 23.9, 121.8, p = 0.004), respiratory rate >24 per minute (+80.7 h, 95%CI 28.0, 133.3, p = 0.003), hemoglobin level <10 mg/dL (+60.4 h, 95%CI 8.6, 112.3, p = 0.022), and serum albumin <3.5 g/dL (+52.8 h, 95%CI 3.6, 102.0, p = 0.035). Conclusions: Poor NYHA functional class, tachypnea, anemia, and hypoalbuminemia are significant clinical predictors of patients with acute heart failure who required longer LOS.

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Natriuretic Peptides as Inclusion Criteria in Clinical Trials

Cited by 58 publications

References 24 publications

Heart failure in COVID‐19 patients: prevalence, incidence and prognostic implications

Heart failure in COVID‐19 patients: prevalence, incidence and prognostic implications

Cardiovascular and Renal Outcomes with Empagliflozin in Heart Failure

Clinical Predictors Influencing the Length of Stay in Emergency Department Patients Presenting with Acute Heart Failure

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