PMID- 16996844 OWN - NLM STAT- MEDLINE DCOM- 20061018 LR - 20161124 IS - 1097-6744 (Electronic) IS - 0002-8703 (Linking) VI - 152 IP - 4 DP - 2006 Oct TI - Adjunctive therapy with low-molecular-weight heparin in patients with chronic heart failure secondary to dilated cardiomyopathy: one-year follow-up results of the randomized trial. PG - 713.e1-7 AB - BACKGROUND: Defective endothelial function has been shown in dilated cardiomyopathy. Therefore, improvement in endothelial function after low-molecular-weight heparin (LMWH) therapy may be clinically beneficial. Consequently, the effect of adjunct enoxaparin, a LMWH, on standard treatment of dilated cardiomyopathy was investigated. METHODS: This was a randomized, standard treatment-controlled, 2-center pilot trial of 102 patients (52 receiving adjunctive therapy with enoxaparin at a dosage of 1.5 mg/kg daily for 3 months and 50 receiving standard therapy with angiotensin-converting enzyme inhibitors, beta-blockers, and diuretics alone) with stable chronic heart failure secondary to dilated cardiomyopathy (New York Heart Association [NYHA] class II and III; left ventricular [LV] ejection fraction, < or = 40%). All patients underwent coronary angiography and endomyocardial biopsy and were clinically stable for at least 6 months before enrollment. The combined primary end point included mortality, urgent heart transplantation, and readmission to hospital due to heart failure progression. The secondary end point was to determine the severity of heart failure (serum level of N-terminal brain natriuretic peptide), cardiac function (LV ejection fraction by radionuclide ventriculography), LV diameters by echocardiography, exercise capacity (changes in NYHA class, changes in peak oxygen consumption), and changes in quality of life (Minnesota Living with Heart Failure questionnaire). The clinical outcome was assessed after 6 and 12 months of therapy. RESULTS: Baseline characteristics were comparable in both groups. Five patients dropped out during 12 months of the study. Twelve patients achieved primary end point (8 in the control group and 4 in the LMWH group). The free survival rate was 94% for the LMWH group and 90% for the controls (not statistically significant). After the 12-month period, in the LMWH group, N-terminal brain natriuretic peptide level and LV diameters decreased significantly (P < .001 and P = .006, respectively), whereas LV systolic function increased (P < .001). Changes in exercise capacity and subjective improvement did not differentiate the groups (nonsignificant). Adverse reactions to the enoxaparin therapy were minor and transient. CONCLUSIONS: In patients with chronic heart failure due to dilated cardiomyopathy, adjunct long-term enoxaparin therapy may offer additional clinical benefit without deleterious effects on major cardiac events. FAU - Wojnicz, Romuald AU - Wojnicz R AD - 3rd Department of Cardiology, Silesian Center of Heart Disease, Silesian Medical University, Zabrze, Poland. wojnicz@dom.zabrze.pl FAU - Nowak, Jolanta AU - Nowak J FAU - Szygula-Jurkiewicz, Bozena AU - Szygula-Jurkiewicz B FAU - Wilczek, Krzysztof AU - Wilczek K FAU - Lekston, Andrzej AU - Lekston A FAU - Trzeciak, Przemyslaw AU - Trzeciak P FAU - Nowalany-Kozielska, Ewa AU - Nowalany-Kozielska E FAU - Zembala, Marian AU - Zembala M FAU - Wodniecki, Jan AU - Wodniecki J FAU - Polonski, Lech AU - Polonski L LA - eng PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't PL - United States TA - Am Heart J JT - American heart journal JID - 0370465 RN - 0 (Anticoagulants) RN - 0 (Cardiovascular Agents) RN - 0 (Enoxaparin) RN - 0 (Peptide Fragments) RN - 0 (pro-brain natriuretic peptide (1-76)) RN - 114471-18-0 (Natriuretic Peptide, Brain) SB - IM MH - Adult MH - Anticoagulants/administration & dosage/adverse effects/*therapeutic use MH - Cardiac Output, Low/diagnostic imaging/*drug therapy/*etiology/physiopathology MH - Cardiomyopathy, Dilated/*complications MH - Cardiovascular Agents/therapeutic use MH - Chronic Disease MH - Drug Administration Schedule MH - Drug Therapy, Combination MH - Echocardiography MH - Enoxaparin/administration & dosage/adverse effects/*therapeutic use MH - Female MH - Follow-Up Studies MH - Humans MH - Male MH - Middle Aged MH - Natriuretic Peptide, Brain/blood MH - Peptide Fragments/blood MH - Pilot Projects MH - Survival Analysis MH - Systole MH - Treatment Outcome MH - Ventricular Function, Left EDAT- 2006/09/26 09:00 MHDA- 2006/10/19 09:00 CRDT- 2006/09/26 09:00 PHST- 2006/02/12 00:00 [received] PHST- 2006/06/26 00:00 [accepted] PHST- 2006/09/26 09:00 [pubmed] PHST- 2006/10/19 09:00 [medline] PHST- 2006/09/26 09:00 [entrez] AID - S0002-8703(06)00625-9 [pii] AID - 10.1016/j.ahj.2006.06.028 [doi] PST - ppublish SO - Am Heart J. 2006 Oct;152(4):713.e1-7. doi: 10.1016/j.ahj.2006.06.028.