Clinical TrialContinuous Ultrafiltration for Congestive Heart Failure: The CUORE Trial
Section snippets
Study Population
The Continuous Ultrafiltration for Congestive Heart Failure (CUORE) trial is a prospective, randomized, unblinded study comparing ultrafiltration and standard medical treatment in patients with large fluid overload due to congestive HF. Consecutive patients were enrolled from August 1, 2006, to May 31, 2010, at 2 Italian Heart Failure units. Inclusion criteria were age >18 years, New York Heart Association (NYHA) functional class III or IV, left ventricular ejection fraction (LVEF) ≤40%,
Results
Sixty-four consecutive patients with overt congestive HF were initially screened and 56 (mean age 75 ± 5 years, 46 men) were included in the study. Twenty-seven patients were randomized to the ultrafiltration group and 29 to the control group (Fig. 1). In the overall population, the average estimated body weight increase due to fluid overload was 8 ± 8 kg.
Baseline characteristics of the 2 groups were similar (Table 1). In particular, the 2 groups had similar NYHA functional class, LVEF, and
Discussion
Ultrafiltration, a mechanical strategy to remove fluid overload in HF patients, has been a matter of intense investigative interest in recent years and is clearly emerging as a useful therapeutic strategy.12, 13, 14, 15, 16, 17, 18 Indeed, several studies have consistently shown that ultrafiltration is able to improve signs and symptoms of congestion, to ameliorate hemodynamics and neurohumoral status, to increase diuresis, and to lower diuretic requirements in patients with advanced HF.12, 13,
Conclusion
The CUORE trial shows that early (first-line) treatment with ultrafiltration in fluid-overloaded HF patients, selected on the basis of only partial responsiveness to diuretics, is associated with a significant long-term reduction in rehospitalizations for HF, without any impact on mortality.
Acknowledgment
The authors acknowledge Ilaria Vicini, PhD, for her important contribution to this work.
Disclosures
None.
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Cited by (0)
Funding: The ultrafiltration device and all accessory kits necessary for the study were kindly supplied by Bellco.
Clinical Trial Registration. ClinicalTrial.gov number: NCT00360958
See page 16 for disclosure information.