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CLINICAL RESEARCH

Outcomes by Gender in the African-American Heart Failure Trial

Anne L. Taylor, MD^_*,_*, JoAnn Lindenfeld, MD, Susan Ziesche, RN, Mary Norine Walsh, MD, Judith E. Mitchell, MD^||, Kirkwood Adams, MD^¶, S. William Tam, PhD^#, Elizabeth Ofili, MD^_**, Michael L. Sabolinski, MD^#, Manuel Worcel, MD^#, Jay N. Cohn, MD^_* for the A-HeFT Investigators

^_* Department of Medicine, University of Minnesota, Minneapolis, Minnesota
University of Colorado Health Science Center, Denver, Colorado
Minneapolis Veterans Affairs Medical Center, Minneapolis, Minnesota
The Care Group, LLC, Indianapolis, Indiana
^|| State University of New York Downstate Medical Center, Brooklyn, New York
^¶ University of North Carolina, Chapel Hill, North Carolina
^# NitroMed, Inc., Lexington, Massachusetts
^_** Morehouse School of Medicine, Atlanta, Georgia

Manuscript received January 9, 2006; revised manuscript received July 31, 2006, accepted August 1, 2006.

^_* Reprint requests and correspondence: Dr. Anne L. Taylor, University of Minnesota Medical School, C694 Mayo Memorial Building, Mayo Mail Code 293, 420 Delaware Street, SE, Minneapolis, Minnesota 55455. (Email: taylo135{at}umn.edu).

OBJECTIVES: Previous trials testing isosorbide dinitrate/hydralazine (I/H) were performed in all-male study cohorts, and thus the efficacy of I/H in women was unknown; 40% of the A-HeFT (African-American Heart Failure Trial) cohort were women. We therefore compared outcomes by gender and treatment.

BACKGROUND: Fixed-dose combined I/H significantly reduced mortality and heart failure hospitalizations and improved quality of life in 1,050 black patients with heart failure treated with background neurohormonal blockade. Previous trials testing I/H were done in all-male study cohorts, and thus the efficacy of I/H in women was unknown.

METHODS: Baseline characteristics and medications were compared between men and women by I/H and placebo treatment. Survival, time to first heart failure hospitalization, change in quality of life, and event-free survival were compared by gender and treatment.

RESULTS: At baseline, women had lower hemoglobin and creatinine levels; less renal insufficiency; and higher body mass indexes, diabetes prevalence, and systolic blood pressures; but worse quality of life scores. All-cause mortality was lower in women than in men treated with I/H but without significant treatment interaction by gender. The primary composite score, which weighted mortality, first heart failure hospitalization, and change in quality of life at 6 months, was similarly improved by I/H in men and women. First heart failure hospitalization and event-free survival (time to death or first heart failure hospitalization) were similarly improved in both genders.

CONCLUSIONS: Fixed-dose I/H improved heart failure outcomes in both men and women in A-HeFT. The I/H significantly improved the primary composite score and event-free survival as well as reduced the risk of first heart failure hospitalizations similarly in both genders. The I/H had a slightly greater mortality benefit in women, but without a significant treatment interaction by gender.

Abbreviations and Acronyms   A-HeFT = African-American Heart Failure Trial   CI = confidence interval   HR = hazard ratio   I/H = isosorbide dinitrate/hydralazine