PMID- 12475466 OWN - NLM STAT- MEDLINE DCOM- 20030115 LR - 20190708 IS - 0735-1097 (Print) IS - 0735-1097 (Linking) VI - 40 IP - 11 DP - 2002 Dec 4 TI - Delisting of infants and children from the heart transplantation waiting list after carvedilol treatment. PG - 2034-8 AB - 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. FAU - Azeka, Estela AU - Azeka E AD - Heart Institute (InCor), University of Sao Paulo Medical School, Sao Paulo, Brazil.estela_azeka9@hotmail.com FAU - Franchini Ramires, Jose Antonio AU - Franchini Ramires JA FAU - Valler, Constante AU - Valler C FAU - Alcides Bocchi, Edimar AU - Alcides Bocchi E LA - eng PT - Clinical Trial PT - Comparative Study PT - Journal Article PT - Randomized Controlled Trial PL - United States TA - J Am Coll Cardiol JT - Journal of the American College of Cardiology JID - 8301365 RN - 0 (Adrenergic beta-Antagonists) RN - 0 (Angiotensin-Converting Enzyme Inhibitors) RN - 0 (Antioxidants) RN - 0 (Carbazoles) RN - 0 (Propanolamines) RN - 0K47UL67F2 (Carvedilol) SB - IM MH - Adrenergic beta-Antagonists/*therapeutic use MH - Angiotensin-Converting Enzyme Inhibitors/therapeutic use MH - Antioxidants/*therapeutic use MH - Blood Pressure/drug effects MH - Brazil MH - Carbazoles/*therapeutic use MH - Carvedilol MH - Child MH - Child Welfare MH - Child, Preschool MH - Chronic Disease MH - Diastole/drug effects MH - Dose-Response Relationship, Drug MH - Double-Blind Method MH - Echocardiography MH - Female MH - Follow-Up Studies MH - Heart Failure/complications/diagnosis/*therapy MH - *Heart Transplantation MH - Humans MH - Infant MH - Infant Welfare MH - Male MH - Propanolamines/*therapeutic use MH - Prospective Studies MH - Radionuclide Ventriculography MH - Severity of Illness Index MH - Stroke Volume/drug effects MH - Systole/drug effects MH - Treatment Outcome MH - Ventricular Dysfunction, Left/complications/diagnosis/therapy MH - *Waiting Lists EDAT- 2002/12/12 04:00 MHDA- 2003/01/16 04:00 CRDT- 2002/12/12 04:00 PHST- 2002/12/12 04:00 [pubmed] PHST- 2003/01/16 04:00 [medline] PHST- 2002/12/12 04:00 [entrez] AID - S0735109702025706 [pii] AID - 10.1016/s0735-1097(02)02570-6 [doi] PST - ppublish SO - J Am Coll Cardiol. 2002 Dec 4;40(11):2034-8. doi: 10.1016/s0735-1097(02)02570-6.