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This Article Figures Only Full Text Full Text (PDF) All Versions of this Article: j.jacc.2006.06.020v1 48/11/2263    most recent Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via Google Scholar Google Scholar Articles by Taylor, A. L. Search for Related Content PubMed Articles by Taylor, A. L.

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