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CLINICAL STUDY: CARDIOMYOPATHY

Dilated cardiomyopathy in dialysis patients—beneficial effects of carvedilol: a double-blind, placebo-controlled trial

Gennaro Cice, MD^*, Luigi Ferrara, MD^*, Attilio Di Benedetto, MD, Pina Elvira Russo, MD^*, Giancarlo Marinelli, MD^*, Francesco Pavese, MD^* and Aldo Iacono, MD, FESC^*

^* Institute of Cardiovascular Clinic and Surgery, Division of Cardiology, Second University of Naples, Naples, Italy
Total Renal Care, Italia-Study Group on Cardiovascular Risk in Uremic Patients, Naples, Italy

Manuscript received May 10, 2000; revised manuscript received September 15, 2000, accepted October 26, 2000.

Reprint requests and correspondence: Dr. Gennaro Cice, Second University of Naples, Institute of Cardiovascular Clinic and Surgery, Division of Cardiology, Piazza L, Miraglia, 2-80138 Napoli, Italy
lugife{at}tin.it

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, 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 six months of therapy, compared with baseline and corresponding placebo values, and they remained constant at one 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.

Abbreviations and Acronyms   ACE = angiotensin-converting enzyme   BP = blood pressure   CHF = congestive heart failure   HR = heart rate   LV = left ventricle, left ventricular   LVEDV = left ventricular end-diastolic volume   LVEF = left ventricular ejection fraction   LVESV = left ventricular end-systolic volume   MI = myocardial infarction   NYHA = New York Heart Association

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