Dilated Cardiomyopathy in Dialysis Patients—Beneficial Effects of Carvedilol: A Double‐Blind, Placebo‐Controlled Trial

Abstract

Objectives. The aim of this study was to investigate, in dialysis patients with symptomatic heart failure, New York Heart Association (NYHA) functional class II or III, whether the addition of carvedilol to conventional therapy is associated with beneficial effects on cardiac architecture, function, and clinical status. Background. Congestive heart failure (CHF) in chronic hemodialyzed patients, particularly when associated with dilated cardiomyopathy, represents an ominous complication and is an independent risk factor for cardiac mortality. Methods. We enrolled 114 dialysis patients with dilated cardiomyopathy. All patients were treated with carvedilol for 12 months in a double-blind, placebo-controlled, randomized trial. The patients underwent M-mode and two-dimensional echocardiography at baseline and 1, 6, and 12 months after the randomization. Each patient's clinical status was assessed using an NYHA functional classification that was determined after 6 and 12 months of treatment. Results. Carvedilol treatment improved left ventricular (LV) function. In the active-treatment group, the increase in LV ejection fraction (from 26.3% to 34.8%; p<0.05 vs. basal and placebo group) and the reduction of both LV end-diastolic volume (from 100 ml/m2 to 94 ml/m2; p<0.05 vs. basal and placebo group) and end-systolic volume (from 74 ml/m2 to 62 ml/m2; p<0.05 vs. basal and placebo group) reached statistical significance after 6 months of therapy, compared with baseline and corresponding placebo values, and they remained constant at 1 year of treatment (p<0.05 vs. basal and placebo group). The clinical status of patients, assessed by NYHA functional classification, improved during the treatment period. Moreover, at the end of the trial, there were no patients in NYHA functional class IV in the carvedilol group, compared with 5.9% of the patients in the placebo arm. Conclusions. One year of therapy with carvedilol in dialysis patients with CHF and dilated cardiomyopathy reduces LV volumes and improves LV function and clinical status.—Cice G, Ferrara L, Di Benedetto A, et al. Dilated cardiomyopathy in dialysis patients—beneficial effects of carvedilol: A double-blind, placebo-controlled trial. J Am Coll Cardiol. 2001;37:407–411. Comment. The authors of this trial sought to determine the effects of β blockade with carvedilol in patients suffering from dilated cardiomyopathy and end-stage renal disease. It is now well established that patients with symptomatic heart failure can gain significant benefit from therapy with β blockers. With this in mind, the authors conducted a double-blind, placebo-controlled trial to assess whether carvedilol therapy has beneficial effects on cardiac remodeling as well as both functional and clinical status. The trial involved 114 dialysis patients who had dilated cardiomyopathic ventricles. The protocol included 12 months of treatment with this α- and β-blocking agent. All patients underwent imaging at the time of randomization and then again at 1-, 6-, and 12-month intervals after starting therapy. Clinical and functional classifications were determined at the 6- and 12-month examinations. The authors found a significant increase in the LV ejection fraction in the treated group. Also, both end-diastolic and end-systolic volumes were significantly reduced. The improvements were consistent and were persistent at the end of 1 full year of treatment. Furthermore, it was noted that patients' clinical status improved during the treatment period, and that the treated group had no significant functional decline. On the basis of their data, the authors concluded that in this very high-risk group of patients, treatment with carvedilol can improve both objective and subjective parameters. Given that heart failure carries a very poor prognosis in dialysis patients, these data should encourage clinicians who care for this unfortunate subpopulation to be aggressive in their pharmacologic interventions. This paper presents very important clinical data that should be considered for integration into standard clinical practice.