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

Mar 07, 2002
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Date Presented:
01/01/2001
Date Published:
01/01/2001
Date Updated:
03/07/2002
Original Posted Date:
03/07/2002
References

Description:

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

Hypothesis:

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. 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.

Study Design

Study Design:

Drug/Procedures Used:

The study consisted of 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.

Principal Findings:

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. 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.

One year of therapy with the carvedilol in dialysis patients with CHF and dilated cardiomyopathy reduces LV volumes and improves LV function and clinical status.

Interpretation:

Approximately 68% of patients in this study had ischemic heart disease as the etiology of cardiomyopathy, with only 24% of patients with cardiomyopathy based on a hypertensive etiology. These findings demonstrate that carvedilol is not only safe in this population but also associated with evidence of clinical benefit. The study design minimizes the variability one would expect in a dialysis population. The benefit may be associated with a reduction of blood pressure in the carvedilol treatment group. With the high morbidity rate in this population, a longer term study with hospitalization and morbid events outcomes would be valuable.

References:

Cice C, Ferrara L, Di Benedetto A, et al. J Am Coll Cardiol 2001;37:407-11.

Keywords: Renal Dialysis, Myocardial Ischemia, Carbazoles, Heart Failure, Risk Factors, Blood Pressure, Propanolamines, Hospitalization, Cardiomyopathy, Dilated, Echocardiography


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