End-Point Selection for Acute Heart Failure Trials

2011 ◽  
Vol 7 (4) ◽  
pp. 481-495
Author(s):  
Larry A. Allen
Keyword(s):  
Heart Failure ◽  
Acute Heart Failure ◽  
Point Selection ◽  
End Point ◽  
Selection For

Key Issues in End Point Selection for Heart Failure Trials: Composite End Points

2005 ◽  
Vol 11 (8) ◽  
pp. 567-575 ◽  
Author(s):  
James D. Neaton ◽  
Gerry Gray ◽  
Bram D. Zuckerman ◽  
Marvin A. Konstam
Keyword(s):  
Heart Failure ◽  
Point Selection ◽  
End Points ◽  
End Point ◽  
Key Issues ◽  
Selection For

scholarly journals Guideline-directed therapy at discharge in patients with heart failure and atrial fibrillation

Heart ◽  
2019 ◽  
Vol 106 (4) ◽  
pp. 292-298 ◽  
Author(s):  
Min-Soo Ahn ◽  
Byung Su Yoo ◽  
Junghan Yoon ◽  
Seung-Hwan Lee ◽  
Jang Young Kim ◽  
...  
Keyword(s):  
Heart Failure ◽  
Atrial Fibrillation ◽  
Acute Heart Failure ◽  
Guideline Adherence ◽  
Angiotensin Receptor Blockers ◽  
Poor Adherence ◽  
Good Adherence ◽  
Reduced Ejection Fraction ◽  
End Point ◽  
Receptor Blockers

ObjectivesThis study evaluated the relationship between guideline adherence for recommended therapy on discharge and relevant 60-day and 1-year clinical outcomes in patients with acute heart failure (HF) with reduced ejection fraction and atrial fibrillation (AF).MethodsOf 5625 acute patients with HF in the Korean Acute Heart Failure registry, 986 patients with HF and documented AF were analysed. Guideline adherence scores were calculated for the prescription of ACE inhibitors, angiotensin receptor blockers, β-blockers, mineralocorticoid receptor antagonists and anticoagulants.ResultsIn patients with HF with AF, there was a significant trend of reduced 60-day and 1-year mortality rates and the composite end point with guideline adherence. According to the Cox proportion hazard model, poor adherence was associated with a significantly higher risk of 60-day mortality (HR 4.75; 95% CI 1.77 to 12.74) and the composite end point (HR 2.36; 95% CI 1.33 to 4.18) compared with good adherence. Furthermore, poor adherence was associated with a significantly higher risk of 1-year mortality compared with moderate (HR 1.64; 95% CI 1.15 to 2.33) and good adherence (HR 2.34; 95% CI 1.39 to 3.97) and with a higher risk of the 1-year composite end point compared with good adherence (HR 1.58; 95% CI 1.07 to 2.33).ConclusionBetter adherence to guidelines was associated with better 60-day and 1-year prognoses in patients with HF with AF.

scholarly journals Effect of comprehensive vasodilation vs usual care on mortality and heart failure rehospitalization in women with acute heart failure

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
D Wussler ◽  
J Walter ◽  
N Kozhuharov ◽  
A Goudev ◽  
D Flores ◽  
...  
Keyword(s):  
Heart Failure ◽  
Usual Care ◽  
Acute Heart Failure ◽  
Plasma Concentrations ◽  
Intervention Group ◽  
Absolute Difference ◽  
Care Group ◽  
Female Patients ◽  
End Point ◽  
All Cause Mortality

Abstract Background Guidelines recommend evaluating the risk/benefit ratio of novel therapies individually in women and men, as the pathophysiology and the response to treatment may differ between women and men. Among patients with acute heart failure (AHF), a strategy of intensive vasodilation, compared with usual care, overall did provide comparable outcomes. Purpose To evaluate the effect of a strategy that emphasized early intensive and sustained vasodilation in women with AHF. Methods In a randomized, open-label blinded-end-point trial patients hospitalized for AHF were enrolled in 10 hospitals in Switzerland, Bulgaria, Germany, Brazil, and Spain. Inclusion criteria were AHF expressed by acute dyspnea and increased plasma concentrations of natriuretic peptides, systolic blood pressure ≥100mmHg, and a plan for treatment in a general ward. Patients were randomized 1:1 to a strategy of early intensive and sustained vasodilation throughout the hospitalization or usual care. The primary end point was a composite of all-cause mortality or rehospitalization for AHF at 180 days. Results Among 788 patients randomized, 781 completed the trial and were eligible for the primary end point analysis. Of these 288 (36.9%) were women. The primary end point, a composite of all-cause mortality or rehospitalization for AHF at 180 days, occurred in 53 female patients (37.9%) in the intervention group (including 28 deaths [20.0%]) and in 34 female patients (23.0%) in the usual care group (including 22 deaths [14.9%]) (absolute difference for the primary end point, 14.9%; adjusted hazard ratio, 1.67 [95% CI: 1.08–2.59]; P=0.02). Clinically significant adverse events with early intensive and sustained vasodilation vs usual care included hypotension (8% vs 2%). Conclusion Among women with AHF, a strategy of early intensive and sustained vasodilation, compared with usual care, had a detrimental effect on a composite outcome of all-cause mortality and AHF rehospitalization at 180 days. Cox Proportional Hazard Curve Funding Acknowledgement Type of funding source: None

Hydration for prevention of kidney injury after primary coronary intervention for acute myocardial infarction: a randomised clinical trial

Heart ◽  
2021 ◽  
pp. heartjnl-2021-319716
Author(s):  
Yong Liu ◽  
Ning Tan ◽  
Yong Huo ◽  
Shiqun Chen ◽  
Jin Liu ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Heart Failure ◽  
Acute Kidney Injury ◽  
Acute Heart Failure ◽  
Diastolic Pressure ◽  
Kidney Injury ◽  
Coronary Intervention ◽  
Left Ventricular ◽  
Controlled Study ◽  
End Point

ObjectiveTo evaluate the efficacy of aggressive hydration compared with general hydration for contrast-induced acute kidney injury (CI-AKI) prevention among patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (pPCI).MethodsThe Aggressive hydraTion in patients with STEMI undergoing pPCI to prevenT Contrast-Induced Acute Kidney Injury study is an open-label, randomised controlled study at 15 teaching hospitals in China. A total of 560 adult patients were randomly assigned (1:1) to receive aggressive hydration or general hydration treatment. Aggressive hydration group received preprocedural loading dose of 125/250 mL normal saline within 30 min, followed by postprocedural hydration performed for 4 hours under left ventricular end-diastolic pressure guidance and additional hydration until 24 hours after pPCI. General hydration group received ≤500 mL 0.9% saline at 1 mL/kg/hour for 6 hours after randomisation. The primary end point is CI-AKI, defined as a >25% or 0.5 mg/dL increased in serum creatinine from baseline during the first 48–72 hours after primary angioplasty. The safety end point is acute heart failure.ResultsFrom July 2014 to May 2018, 469 patients were enrolled in the final analysis. CI-AKI occurred less frequently in aggressive hydration group than in general hydration group (21.8% vs 31.1%; risk ratio (RR) 0.70, 95% CI 0.52 to 0.96). Acute heart failure did not significantly differ between the aggressive hydration group and the general hydration group (8.1% vs 6.4%, RR 1.13, 95% CI 0.66 to 2.44). Several subgroup analysis showed the better effect of aggressive hydration in CI-AKI prevention in male, renal insufficient and non-anterior myocardial infarction participants.ConclusionsComparing with general hydration, the peri-operative aggressive hydration seems to be safe and effective in preventing CI-AKI among patients with STEMI undergoing pPCI.

scholarly journals Systolic Blood Pressure and Outcome in Patients Admitted With Acute Heart Failure: An Analysis of Individual Patient Data From 4 Randomized Clinical Trials

2021 ◽  
Author(s):  
Johannes Grand ◽  
Kristina Miger ◽  
Ahmad Sajadieh ◽  
Lars Køber ◽  
Christian Torp‐Pedersen ◽  
...  
Keyword(s):  
Heart Failure ◽  
Blood Pressure ◽  
Systolic Blood Pressure ◽  
Acute Heart Failure ◽  
Left Ventricular Ejection ◽  
Long Term Outcomes ◽  
Short Term ◽  
End Point ◽  
All Cause Mortality

BACKGROUND In acute heart failure (AHF), systolic blood pressure (SBP) is an important clinical variable. This study assessed the association between SBP and short‐term and long‐term outcomes in a large cohort of patients with AHF. METHODS AND RESULTS This is an analysis of 4 randomized controlled trials investigating serelaxin versus placebo in patients admitted with AHF and SBPs from 125 to 180 mm Hg. Outcomes were 180‐day all‐cause mortality and a composite end point of all‐cause mortality, worsening heart failure, or hospital readmission for heart failure the first 14 days. Left ventricular ejection fraction (LVEF) was examined as LVEF<40% and LVEF≥40%. Multivariable Cox regression models were adjusted for known confounders of outcomes in AHF. A total of 10 533 patients with a mean age of 73 (±12) years and a mean SBP of 145 (±7) mm Hg were included. LVEF was assessed in 9863 patients (93%); 4737 patients (45%) had LVEF<40%. Increasing SBP was inversely associated with 180‐day mortality (adjusted hazard ratio [HR adjusted ], 0.93; 95% CI, 0.89–0.98; P =0.008 per 10 mm Hg increase) and with the composite end point (HR adjusted , 0.90; 95% CI, 0.85–0.94; P <0.001 per 10 mm Hg increase). A significant interaction with LVEF was observed, revealing that SBP was not associated with mortality in patients with LVEF≥40% (HR adjusted , 0.98; 95% CI, 0.91–1.04; per 10 mm Hg increase), but was strongly associated with increased mortality in LVEF<40% (HR adjusted , 0.84; 95% CI, 0.77–0.92; per 10 mm Hg increase). CONCLUSIONS Elevated SBP is associated with favorable short‐term and long‐term outcomes in patients with AHF. In our predefined subgroup analysis, we found that baseline SBP was not associated with mortality in LVEF≥40%, but was strongly associated with mortality in patients with LVEF<40%.

scholarly journals Prevalence and prognostic implications of active cytomegalovirus infection in patients with acute heart failure

2010 ◽  
Vol 119 (10) ◽  
pp. 443-452 ◽  
Author(s):  
Julio Núñez ◽  
Marifina Chilet ◽  
Juan Sanchis ◽  
Vicent Bodí ◽  
Eduardo Núñez ◽  
...  
Keyword(s):  
Heart Failure ◽  
Acute Heart Failure ◽  
Cox Regression ◽  
Cmv Infection ◽  
Cox Regression Analysis ◽  
End Point ◽  
Cytomegalovirus Reactivation ◽  
Cytokines And Chemokines ◽  
Key Factor ◽  
Inflammatory State

AHF (acute heart failure) causes significant morbidity and mortality. Recent studies have postulated that the expression of inflammatory mediators, such as cytokines and chemokines, plays an important role in the development and progression of heart failure. A pro-inflammatory state has been postulated as a key factor in triggering CMV (cytomegalovirus) reactivation. Therefore we sought to determine the prevalence of active CMV infection in immunocompetent patients admitted for AHF and to quantify the association with the risk of the combined end point of death or AHF readmission. A total of 132 consecutive patients admitted for AHF were enrolled in the present study. Plasma CMV DNAaemia was assessed by qRT-PCR (quantitative real-time PCR), and cytokine measurements in plasma were performed by ELISA. Clinical data were evaluated by personnel blinded to CMV results. The independent association between active CMV infection and the end point was determined by Cox regression analysis. During a median follow-up of 120 [IQR (interquartile range), 60–240] days, 23 (17.4%) deaths, 34 (24.2%) readmissions for AHF and 45 (34.1%) deaths/readmissions for AHF were identified. Plasma CMV DNAaemia occurred in 11 (8.3%) patients, albeit at a low level (<100 copies/ml). The cumulative rate of the composite end point was higher in patients with CMV DNAaemia (81.8 compared with 29.8%; P<0.001). After adjusting for established risk factors, the occurrence of CMV DNAaemia was strongly associated with the clinical end point [hazard ratio = 4.39 (95% confidence interval, 2.02–9.52); P<0.001]. In conclusion, active CMV infection occurs, although uncommonly, in patients with AHF, and may be a marker of disease severity.

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