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CLINICAL STUDY

Delisting of infants and children from the heart transplantation waiting list after carvedilol treatment

^a Heart Institute (InCor), University of São Paulo Medical School, São Paulo, Brazil

Manuscript received March 11, 2002; revised manuscript received August 5, 2002, accepted August 26, 2002.

^* Reprint requests and correspondence: Dr. Estela Azeka, Rua Araripina 95, São Paulo, São Paulo, Brazil 05603-030.
estela_azeka9{at}hotmail.com

OBJECTIVES: We performed a prospective, randomized, double-blind, placebo-controlled study of carvedilol effects in children with severe, chronic heart failure (HF), despite the use of conventional therapy.

BACKGROUND: Little is known about the effects of carvedilol in youngsters with chronic HF and severe left ventricular (LV) dysfunction.

METHODS: We conducted a double-blind, placebo-controlled study of 22 consecutive children with severe LV dysfunction. The children had chronic HF and left ventricular ejection fraction (LVEF) <30%. Patients were randomly assigned to receive either placebo (8 patients) or the beta-blocker carvedilol (14 patients) at 0.01 mg/kg/day titrated up to 0.2 mg/kg/day, followed-up for six months.

RESULTS: During the follow-up and the up-titration period in the carvedilol group, four patients died and one underwent heart transplantation. In patients receiving carvedilol evaluated after six months, a significant increase occurred in LVEF, from 17.8% (95% confidence interval [CI], 14.1 to 21.4%) to 34.6% (95% CI, 25.2 to 44.0%); p = 0.001. Modified New York Heart Association (NYHA) functional class improved in nine patients taken off the transplant waiting list. All nine patients were alive at follow-up. In the placebo group, during the six-month follow-up, two patients died, and two underwent heart transplantation. Four patients persisted with HF symptoms (NYHA functional class IV). No significant change occurred in LVEF or fractional shortening.

CONCLUSIONS: Carvedilol added to standard therapy may reduce HF progression and improve cardiac function, allowing some youngsters to be removed from the heart transplantation waiting list.

Abbreviations and Acronyms   ANOVA   repeated-measures analysis of variance   FS   fractional shortening   HF   heart failure   LV   left ventricular/ventricle   LVDI   left ventricular diastolic index   LVEF   left ventricular ejection fraction   NYHA   New York Heart Association

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