End Points for Clinical Trials in Acute Heart Failure Syndromes

Allen, Larry A.; Hernandez, Adrian F.; O’Connor, Christopher M.; Felker, G. Michael

doi:10.1016/j.jacc.2008.12.079

Cited by 90 publications

(68 citation statements)

References 50 publications

(74 reference statements)

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Composite end points have been used in many HF trials to increase statistical power. 35,36 However, composite end points increase statistical power only if the intervention has a similar effect on multiple aspects of the composite. The inclusion of factors in the composite end point that are not affected by the intervention or even are affected negatively dilutes the observed treatment effect and decreases the overall statistical power.…”

Section: Discussionmentioning

confidence: 99%

Randomized, Controlled Trial to Improve Self-Care in Patients With Heart Failure Living in Rural Areas

et al. 2014

View full text Add to dashboard Cite

Background— Patients with heart failure (HF) who live in rural areas have less access to cardiac services than patients in urban areas. We conducted a randomized, clinical trial to determine the impact of an educational intervention on the composite end point of HF rehospitalization and cardiac death in this population. Methods and Results— Patients (n=602; age, 66±13 years; 41% female; 51% with systolic HF) were randomized to 1 of 3 groups: control (usual care), Fluid Watchers LITE, or Fluid Watchers PLUS. Both intervention groups included a face-to-face education session delivered by a nurse focusing on self-care. The LITE group received 2 follow-up phone calls, whereas the PLUS group received biweekly calls (mean, 5.3±3.6; range, 1–19) until the nurse judged the patient to be adequately trained. Over 2 years of follow-up, 35% of patients (n=211) experienced cardiac death or hospitalization for HF, with no difference among the 3 groups in the proportion who experienced the combined clinical outcome ( P =0.06). Although patients in the LITE group had reduced cardiac mortality compared with patients in the control group over the 2 years of follow-up (7.5% and 17.7%, respectively; P =0.003), there was no significant difference in cardiac mortality between patients in the PLUS group and the control group. Conclusions— A face-to-face education intervention did not significantly decrease the combined end point of cardiac death or hospitalization for HF. Increasing the number of contacts between the patient and nurse did not significantly improve outcome. Clinical Trial Registration— http://www.clinicaltrials.gov . Unique identifier: NCT00415545.

show abstract

Section: Discussionmentioning

confidence: 99%

Randomized, Controlled Trial to Improve Self-Care in Patients With Heart Failure Living in Rural Areas

et al. 2014

View full text Add to dashboard Cite

show abstract

“…Acute heart failure syndromes remain a major cause of morbidity and mortality, in part because of the lack of definitive evidence for AHFS management and risk stratification parameters [33]. As recently stated by Weintraub et al [21], there is a clinical need to identify clinical and laboratory tools useful for risk stratification in the AHF population, given its heterogeneity.…”

Section: Discussionmentioning

confidence: 99%

Acute hyperglycemia and insulin resistance in acute heart failure syndromes without previously known diabetes

et al. 2011

View full text Add to dashboard Cite

No data is so far available on the relation between glucose values and insulin resistance and mortality, both at short-and long-term, in patients with acute heart failure syndromes (AHF). We prospectively assessed in 100 consecutive non-diabetic AHF patients whether acute glucose metabolism, as indicated by fasting glycemia and insulin resistance (HOMA index) was able to affect short-and long-term mortality. In the overall population, 51 patients showed admission glucose values [140 mg/dl. No significant difference was observed in admission and peak glycemia, insulin and C-peptide values and in HOMA-index between dead and survived patients. At multivariate logistic backward stepwise analysis the following variables were independent predictors for in-ICCU mortality (when adjusted for left ventricular ejection frac- In consecutive patients with acute heart failure without previously known diabetes, we documented, for the first time, that fasting glucose and insulin values and insulin resistance do not affect mortality at short-and longterm. Inflammatory activation (as indicated by the leukocyte count and the fibrinogen) and NT-pro BNP levels are independent predictors for early death while the eGFR affects the long-term mortality.

show abstract

“…The end points used in mouse studies should, where possible, be clinically valid (for example, by using the same imaging modalities when studying cardiac morphology in mice and heart failure patients) (Allen et al, 2009). It is worth pointing out that many of the clinical end points that are important to doctors, patients and healthcare systems alike, such as quality of life, exercise tolerance and hospital admission, are unlikely to be modelled adequately in any animal system.…”

Section: Resultsmentioning

confidence: 99%

Heart failure and mouse models

Breckenridge¹

2010

Disease Models &Amp; Mechanisms

View full text Add to dashboard Cite

Heart failure is a common, complex condition with a poor prognosis and increasing incidence. The syndrome of heart failure comprises changes in electrophysiology, contraction and energy metabolism. This complexity, and the interaction of the clinical syndrome with very frequently concurrent medical conditions such as diabetes, means that animal modelling of heart failure is difficult. The current animal models of heart failure in common use do not address several important clinical problems. There have been major recent advances in the understanding of cardiac biology in the healthy and failing myocardium, but these are, as yet, unmatched by advances in therapeutics. Arguably, the development of new animal models of heart failure, or at least adaptation of existing models, will be necessary to fully translate scientific advances in this area into new drugs. This review outlines the mouse models of heart failure in common usage today, and discusses how adaptations in these models may allow easier translation of animal experimentation into the clinical arena.

show abstract

End Points for Clinical Trials in Acute Heart Failure Syndromes

Cited by 90 publications

References 50 publications

Randomized, Controlled Trial to Improve Self-Care in Patients With Heart Failure Living in Rural Areas

Randomized, Controlled Trial to Improve Self-Care in Patients With Heart Failure Living in Rural Areas

Acute hyperglycemia and insulin resistance in acute heart failure syndromes without previously known diabetes

Heart failure and mouse models

Contact Info

Product

Resources

About