End Point Selection in Acute Decompensated Heart Failure Clinical Trials: Economic End Points

2011 ◽  
Vol 7 (4) ◽  
pp. 529-537
Author(s):  
Shelby D. Reed ◽  
Zubin J. Eapen ◽  
Kevin A. Schulman
Keyword(s):  
Heart Failure ◽  
Clinical Trials ◽  
Acute Decompensated Heart Failure ◽  
Decompensated Heart Failure ◽  
Point Selection ◽  
End Points ◽  
End Point

Levosimendan: A Novel Inotropic Agent for Treatment of Acute, Decompensated Heart Failure

2005 ◽  
Vol 39 (11) ◽  
pp. 1888-1896 ◽  
Author(s):  
Grace L Earl ◽  
James T Fitzpatrick
Keyword(s):  
Heart Failure ◽  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Acute Decompensated Heart Failure ◽  
Decompensated Heart Failure ◽  
Mortality Data ◽  
Pharmacokinetic Studies ◽  
Dependent Manner ◽  
Term Survival ◽  
Calcium Sensitizer

OBJECTIVE To review the literature on a novel calcium sensitizer, levosimendan. DATA SOURCES Articles were identified through searches of MEDLINE (1966–June 2005), International Pharmaceutical Abstracts (1970–June 2005), and EMBASE (1992–June 2005) using the key words levosimendan, simendan, calcium sensitizer, calcium sensitiser, and congestive heart failure. STUDY SELECTION AND DATA EXTRACTION Clinical trials and pharmacokinetic studies evaluating the safety and efficacy of levosimendan were selected. DATA SYNTHESIS Levosimendan 6–24 μg/kg intravenous bolus followed by a 24-hour continuous infusion of 0.05—0.2 μg/kg/min improved cardiac output and reduced pulmonary capillary wedge pressure in a dose-dependent manner. Dose-ranging and randomized clinical trials have demonstrated improvement in symptoms and hemodynamics and short-term survival outcomes in the treatment of acute, decompensated heart failure. Clinical trials evaluating retrospective mortality data and combined endpoints (mortality, rehospitalization) have demonstrated better outcomes with levosimendan compared with dobutamine. The incidence of hypotension with levosimendan is not significantly different than with dobutamine, but there is a dose-related increase in heart rate. CONCLUSIONS Levosimendan is useful in moderate to severe low-output heart failure in patients who have failed to respond to diuretics and vasodilators. Based on current studies, levosimendan appears to be a safe alternative to dobutamine for treatment of acute, decompensated heart failure. Prospective clinical trials are needed to confirm the effect of levosimendan on long-term survival and its role in heart failure in the setting of myocardial infarction.

Medical Therapy for Acute Decompensated Heart Failure: What Recent Clinical Trials Have Taught Us About Diuretics and Vasodilators

2011 ◽  
Vol 9 (1) ◽  
pp. 1-7 ◽  
Author(s):  
Catherine Marti ◽  
Robert Cole ◽  
Andreas Kalogeropoulos ◽  
Vasiliki Georgiopoulou ◽  
Javed Butler
Keyword(s):  
Heart Failure ◽  
Clinical Trials ◽  
Medical Therapy ◽  
Acute Decompensated Heart Failure ◽  
Decompensated Heart Failure

scholarly journals Prognostic impact of uric acid in patients with acute decompensated heart failure

2021 ◽  
Vol 93 (9) ◽  
pp. 1066-1072
Author(s):  
Svetlana N. Nasonova ◽  
Anastasiya E. Lapteva ◽  
Igor V. Zhirov ◽  
Dzambolat R. Mindzaev ◽  
Sergey N. Tereshchenko
Keyword(s):  
Heart Failure ◽  
Uric Acid ◽  
Acute Decompensated Heart Failure ◽  
Nyha Class ◽  
Decompensated Heart Failure ◽  
Prognostic Impact ◽  
Diuretic Resistance ◽  
End Point ◽  
Significant Difference ◽  
Moderate Negative Correlation

Aim. To evaluate the prognostic impact of serum uric acid (SUA) on clinical outcomes in patients with acute decompensated heart failure, as well as identify the correlation between hyperuricemia and renal function and diuretic resistance in these patients. Materials and methods. The study included 175 patients (125 men and 50 women) with NYHA class IIIV acute decompensated heart failure. Median age was 64 (5675) years. The Information regarding the survival was obtained 3 years after the admission by telephone calls. Results. 57 patients reached the end point (death from all causes); therefore, all patients were divided into groups: "alive", "dead". The SUA levels did not differ in the groups. The only significant difference in the studied parameters was the estimated glomerular filtration rate (eGFR), which was significantly higher in the "alive" group [70.5 (52.894) and 56 (4079), respectively; p=0.006]. A moderate negative correlation was found between SUA levels and eGFR in the correlation analysis (r=-0.313, p0.001). A comparative analysis showed, that SUA level on admission was significantly higher in patients who subsequently received increased doses of diuretics than in patients with a satisfactory response to standard doses of diuretics [567.8 (479.6791.9) and 512 (422.4619.4), respectively; p=0.011]. Also, higher eGFR level on admission was observed in patients from the normal SUA level group than in patients from the hyperuricemia group [94 (74.5101.5) and 63 (48.881.3), respectively; p=0.002]. Conclusion. We found no significant differences in the uric acid level in patients who reached the end point and those who did not reach it during the three-year follow-up. However, the found correlation between uric acid levels and diuretic resistance calls for further research.

Ultrafiltration versus intravenous loop diuretics in patients with acute decompensated heart failure: a meta-analysis of clinical trials

2017 ◽  
Vol 72 (2) ◽  
pp. 132-141 ◽  
Author(s):  
Mohamad Kabach ◽  
Hassan Alkhawam ◽  
Sachil Shah ◽  
Georges Joseph ◽  
Elie M. Donath ◽  
...  
Keyword(s):  
Heart Failure ◽  
Clinical Trials ◽  
Acute Decompensated Heart Failure ◽  
Meta Analysis ◽  
Decompensated Heart Failure ◽  
Loop Diuretics

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

Early Goal-Directed Renal Replacement Therapy in Acute Decompensated Heart Failure Patients with Cardiorenal Syndrome

2021 ◽  
pp. 1-9
Author(s):  
Yeqing Xie ◽  
Jiahui Chen ◽  
Jiarui Xu ◽  
Bo Shen ◽  
Jianquan Liao ◽  
...  
Keyword(s):  
Heart Failure ◽  
Renal Replacement Therapy ◽  
Replacement Therapy ◽  
Acute Decompensated Heart Failure ◽  
Urine Volume ◽  
Decompensated Heart Failure ◽  
Cardiorenal Syndrome ◽  
Inhospital Mortality ◽  
Early Group ◽  
End Point

<b><i>Introduction:</i></b> The aim of this study was to clarify the efficacy of early goal-directed renal replacement therapy (GDRRT) for treatment of cardiorenal syndrome (CRS) patients after acute decompensated heart failure (ADHF). <b><i>Methods:</i></b> In the retrospective, observational study, we enrolled 54 patients in the early GDRRT group and 63 patients in the late GDRRT group. Baseline characteristics, clinical data at initiation renal replacement therapy time, and the clinical outcome were collected and several parameters were compared and analyzed between 2 groups. <b><i>Results:</i></b> The urine volume at GDRRT initiation time in the early group was higher than that in the late GDRRT group (1,060.3 ± 332.1 vs. 300.5 ± 148.3 mL, <i>p</i> &#x3c; 0.001). Hemodynamic parameters such as mean artery pressure were higher (70.06 ± 32.99 vs. 54.34 ± 40.88 mm Hg, <i>p</i> = 0.012), the heart rate was slower (80.17 ± 15.26 vs. 99.21 ± 25.45 bpm, <i>p</i> = 0.002), and the diameter of inferior vena cava was narrower (22.00 ± 1.91 vs. 25.77 ± 5.5 mm, <i>p</i> = 0.04) in early GDRRT. Primary end point was inhospital all-cause mortality and cardiovascular mortality, which was obviously lower in the early GDRRT group (respectively 24.1 vs. 60.3%, <i>p</i> = 0.002 and 20.3 vs. 50.8%, <i>p</i> = 0.005). The second end point of kidney recovery in the early GDRRT group was much better than that in the latter GDRRT group (<i>p</i> = 0.018). Moreover, urine volume after GDRRT of the early group was more significant than that of the late group (1,432 ± 172 vs. 702 ± 183 mL, <i>p</i> = 0.005). <b><i>Conclusion:</i></b> This study clarified the effectiveness of the early GDRRT strategy in ADHF patients suffered from CRS, which reduced inhospital mortality and improved the urine output and clinical kidney recovery outcome.

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