Clinical exacerbations as a surrogate end point in heart failure research

Surrogate end points in heart failure.

Because of the increasing number of pharmacologic strategies available for treatment of heart failure (HF), the time has come to reassess the adequacy of end points used to evaluate therapeutic efficacy. Interest in the use of surrogate end points in clinical studies is increasing. A surrogate end point is defined as a measurement that can substitute for a true end point for the purpose of comp...

Arterial stiffness as surrogate end point: needed clinical trials.

Classic risk scores may underestimate the risk of cardiovascular (CV) events in specific risk groups suitable for primary prevention, such as asymptomatic hypertensive subjects. Particularly, those considered as at intermediate risk may benefit the most from a reassessment of their CV risk using novel biomarkers. In primary prevention, some imaging biomarkers, such as arterial stiffness, enhanc...

Validity of Vascular Calcification as a Screening Tool and as a Surrogate End Point in Clinical Research.

Development of Therapeutics for Heart Failure A Global Rank End Point for Clinical Trials in Acute Heart Failure

Hospitalization for acute heart failure (AHF) is a major public health problem, with 1 million hospitalizations annually in the United States.1 The development of new therapies for patients with AHF remains a significant challenge.2 One aspect of clinical trial design in AHF that has been particularly vexing is the choice of appropriate end points, a topic that has recently been reviewed in det...

Protein C as a surrogate end-point for clinical trials of sepsis

Identification of good surrogate end-points can greatly facilitate the design of clinical trials. Using data from PROWESS and ENHANCE, Shorr and colleagues explore the potential value of several plasma biomarkers for treatment trials of activated protein C for severe sepsis. Based on the framework proposed by Vasan, they tested the utility of several factors (protein C, interleukin-6, antithrom...