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Efficacy of Isosorbide Dinitrate/Hydralazine in HF Patients

This project investigates if adding isosorbide dinitrate/hydralazine to optimized heart failure (HF) treatment reduces all-cause mortality in non-African American patients with reduced ejection fraction compared to placebo. Previous trials showed positive results in African Americans and men. However, there is limited data on the efficacy of this treatment in non-African Americans. The study aims to fill this gap and evaluate the potential benefits in this patient population. The project will look into patient inclusion criteria, the impact of resynchronization therapy, major outcomes, and cost-efficient study methods.

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Efficacy of Isosorbide Dinitrate/Hydralazine in HF Patients

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  1. Heart Failure ProjectGroups 3 and 4 • Among people who self-identify themselves as non-African Americans, does the addition of isosorbidedinitrate/hydralazine (I/H) added to optimized background treatment for participants with heart failure and reduced ejection fraction reduce all-cause mortality as compared to placebo.

  2. Study Rationale • Data from early trials done in men indicate that I/H may be an effect HF treatment. • A trial done in African Americans was stopped early due to a mortality difference favoring I/H. • Use of I/H is not common. • Morbidity and mortality due to HF remains high. • Comparative data on the efficacy of I/H for non-African Americans in the current era of treatments for HF do not exist.

  3. V-HeFT I: All-cause Mortality in Black and White Patients Black patients White patients 100 100 95 95 HR=0.53 P=0.04 HR=0.88 P=0.47 90 90 85 85 80 80 75 75 70 70 Percent survival Percent survival 65 65 60 60 55 55 50 50 Treatment Group H-I (H) Placebo (P) Treatment Group H-I (H) Placebo (P) 45 45 40 40 35 35 30 30 0 P (N=79) H (N=49) 365 P (N=61) H (N=43) 730 P (N=44) H (N=36) 1095 P (N=29) H (N=28) 1460 P (N=14) H (N=16) 1825 P (N=14) H (N=16) 0 P (N=192) H (N=132) 365 P (N=140) H (N=102) 730 P (N=91) H (N=71) 1095 P (N=55) H (N=42) 1460 P (N=27) H (N=22) 1825 P (N=8) H (N=9) Days since randomization date Days since randomization date Carson P, et al. J Cardiac Fail. 1999;5:178-187.

  4. V-HeFT II: All-cause Mortality in Black and White Patients Black patients White patients 100 100 95 95 HR=1.01 P=NS HR=1.32 P=0.02 90 90 85 85 80 80 75 75 70 70 Percent survival Percent survival 65 65 60 60 55 55 50 50 Treatment Group H-I (H) Enalapril (E) Treatment Group H-I (H) Enalapril (E) 45 45 40 40 35 35 30 30 0 P (N=106) H (N=109) 365 P (N=93) H (N=92) 730 P (N=69) H (N=67) 1095 P (N=47) H (N=49) 1460 P (N=24) H (N=29) 1825 P (N=1) H (N=2) 0 P (N=292) H (N=282) 365 P (N=251) H (N=231) 730 P (N=194) H (N=171) 1095 P (N=123) H (N=105) 1460 P (N=66) H (N=55) 1825 P (N=1) H (N=1) Days since randomization date Days since randomization date Carson P, et al. J Cardiac Fail. 1999;5:178-187.

  5. A-HeFT: 43% Decrease in Mortality 100 Isosorbide dinitrate/hydralazine 95 Survival (%) 90 Placebo HR=0.57 P=0.01 85 0 100 200 300 400 500 600 Days since baseline visit ISDN/HYD518 463 407 359 313 251 13 Placebo 532 466 401 340 285 232 24 Taylor AL, et al. N Engl J Med. 2004;351:2049-2057.

  6. Questions To Consider • Inclusion criteria • Impact of resynchronization therapy on event rates. • Major outcomes to consider • How to conduct the study simply and cost-efficiently (e.g., large, simple trial)

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