Late Breaking Clinical Trials Presented at HFSA 13th Annual Scientific Meeting


September 17, 2009

September 17, 2009 – The 13th Annual Scientific Meeting of the Heart Failure Society of America (HFSA) on Wednesday featured four late breaking clinical trials. The three-day meeting in Boston serves as a forum for heart failure specialists to present research findings and advances in treatment and addresses emerging trends in research and new developments in the approach to treating heart failure patients.

The late-breaking trials were:

• “Clinical and prognostic value of Galectin-3, a novel fibrosis-associated biomarker, in patients with chronic heart failure,” – This trial concluded that GAL-3 is a powerful novel marker with incremental value for outcome stratification in patients with chronic HF which is independent of the severity of HF as reflected by plasma BNP levels.

• “Relationship of resting myocardial perfusion to death and hospitalization in heart failure patients: results from the nuclear sub-study of the HF-ACTION trial” – This nuclear substudy of the HF-ACTION trial provided unique information regarding the prognostic significance of variables derived from gated SPEC MPI and the potential role of resting perfusion defects in predicting adverse outcomes in HF patients with reduced LV EF from a large, recently completed prospective clinical trial.

• “Renoprotective and potassium sparing effects of low-dose dopamine in acute decompensated heart failure” – This trial hypothesized that low-dose dopamine exerts renoprotective and potassium sparing effects when administered in patients with ADHF. It concluded that the combination of low-dose furosemide and dopamine achieves equally effective diuresis but reduced renal and electrolyte complication rates as compared to high dose furosemide infusion. Larger studies are needed to confirm these findings and elucidate the effects of dopamine on renal function in ADHF patients.

• “MARVEL-1: A double-blind, randomized, controlled multicenter study to assess the safety and cardiovascular effects of Myocell implantation by a catheter delivery system in congestive heart failure patients post myocardial infarction” – MARVEL-1 was the first double-blind placebo controlled study to assess intramyocardial myoblast administration using a percutaneous approach in patients with advanced ventricular dysfunction. A relatively high arrhythmic event rate was observed, but was short lived. Clinical meaningful trends in improvements in 6-MWT compared with placebo administration were observed. Given the limited treatment options in these patients, myoblast therapy warrants continued evaluation. These results will impact the design of future studies in this field.

"These four late breaking clinical trials highlight some of the interesting innovations in heart failure treatment," said Douglas Mann, M.D., HFSA president. "We are proud to have such important trials unveiled during the annual meeting."

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