Deteriorating renal function in patients with heart failure is a common situation, affecting approximately a third of patients presenting with acute pulmonary oedema, and is associated with worse outcomes. Due to the potentially nephrotoxic nature of many heart failure therapies, renal failure leads to difficult treatment decisions regarding ongoing diuretic therapy. Few options yet exist in this challenging clinical situation, however one potential option is mechanical ultrafiltration devices but currently there is a lack of evidence to support their use.
In this multicenter, randomized, open-label study a total of 188 patients with acute decompensated heart failure, worsened renal function, and persistent congestion were allocated in a 1:1 fashion either to a strategy of stepped pharmacologic therapy or ultrafiltration. The primary end point was the bivariate change from baseline in the serum creatinine level and body weight, as assessed 96 hours after group assignment with patients followed for a total of 60 days. The results did not support the use of ultrafiltration which was inferior to pharmacologic therapy with respect to the bivariate end point (P=0.003), owing primarily to an increase in the creatinine level in the ultrafiltration group. At 96 hours, the mean change in the creatinine level in the pharmacologic-therapy group was -3.5±46.9 μmol/l, as compared with +20.3±61.9 μmol/l in the ultrafiltration group (P=0.003). There was no significant difference in weight loss seen between the two groups (P=0.58). Added to this, a higher percentage of patients in the ultrafiltration group than in the pharmacologic-therapy group had a serious adverse event (72% vs. 57%, P=0.03), mainly related to device and access issues.
In this randomized study involving patients with acute decompensated heart failure and poor renal function, the use of a stepped pharmacologic-therapy algorithm was superior to a strategy of ultrafiltration. Ultrafiltration was also associated with a higher adverse event rate.
- Bart BA, Goldsmith SR, Lee KL, Givertz MM, O’Connor CM, Bull DA, Redfield MM, Deswal A, Rouleau JL, Lewinter MM, Ofili EO, Stevenson LW, Semigran MJ, Felker GM, Chen HH, Hernandez AF, Anstrom KJ, McNulty SE, Velazquez EJ, Ibarra JC, Mascette AM, Braunwald E; the Heart Failure Clinical Research Network. Ultrafiltration in Decompensated Heart Failure with Cardiorenal Syndrome. N Engl J Med. 2012 Nov 6. [Epub ahead of print]