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V-HeFT II: Vasodilator – Heart Failure Trial. Purpose To compare the efficacy of the ACE inhibitor enalapril with that of hydralazine plus isosorbide dinitrate in patients with chronic congestive heart failure Reference

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V heft ii vasodilator heart failure trial
V-HeFT II: Vasodilator–Heart Failure Trial

Purpose

To compare the efficacy of the ACE inhibitor enalapril with that of hydralazine plus isosorbide dinitrate in patients with chronic congestive heart failure

Reference

Cohn JN, Johnson G, Ziesche S et al. A comparison of enalapril with hydralazine–isosorbide dinitrate in the treatment of chronic congestive heart failure. N Engl J Med 1991;325:303–10.


V heft ii vasodilator heart failure trial trial design
V-HeFT II: Vasodilator–Heart Failure Trial- TRIAL DESIGN -

Design: Multicenter, randomized, double-blind

Patients: 804 patients, aged 18–75 years, with evidence of cardiac dysfunction in association with reduced exercise tolerance, receiving digoxin and diuretic therapy; patients with MI in previous 3 months or angina pectoris limiting exercise excluded

Follow up and primary endpoint: Primary endpoint: all-cause mortality. Mean 2.5 years follow up.

Treatment: Patients randomized to either:

  • Enalapril 10 mg twice daily, placebo matching hydralazine and placebo matching isosorbide dinitrate, or

  • Hydralazine 75 mg and isosorbide dinitrate 40 mg, both four times daily, and placebo matching enalapril


V heft ii vasodilator heart failure trial results
V-HeFT II: Vasodilator–Heart Failure Trial- RESULTS -

  • Mortality in enalapril arm, compared with hydralazine–isosorbide:

    • significantly lower at 2 years (18 vs. 25%, P=0.016)

    • lower over entire trial period (0.5–5.7 years), but not significantly so (32.8 vs. 38.2%, P=0.08)

    • differences attributed to significantly fewer sudden deaths

  • Left ventricular ejection fraction significantly higher in both arms over 3 years (P=0.0001), and significantly more so with hydralazine–isosorbide than with enalapril at 13 weeks (P=0.026)

  • O2 consumption at peak exercise levels significantly increased above baseline by hydralazine–isosorbide at 13 weeks and 6 months (by 0.6 and 0.8 mL/kg/min, respectively, both P<0.0001) but not by enalapril, declining after 1 year

  • Incidence of hypotension and cough significantly higher with enalapril; headache significantly higher with hydralazine–isosorbide


V heft ii vasodilator heart failure trial results continued

Enalapril

Hydralazine–

isosorbide

dinitrate

V-HeFT II: Vasodilator–Heart Failure Trial- RESULTS continued-

Cumulative mortality

Cumulative

0.75

mortality

0.50

0.25

0

0

12

24

36

48

60

Months after randomization

Cohn et al. N Engl J Med 1991; 325:303–10.


V heft ii vasodilator heart failure trial results continued1

Cardiac

112 (85)

137 (89)

Sudden, no warning

41 (37)

16

63 (46)

25

0.015

Sudden, with warning

16 (14)

7

29 (21)

12

0.032

Due to pump failure

50 (5)

23

40 (29)

19

0.44

Other or unknown

5 (5)

5 (4)

Noncardiac

20

11

16

9

0.63

Cancer

9

9

V-HeFT II: Vasodilator–Heart Failure Trial- RESULTS continued-

Cause of death

Hydralazine

isosorbide

Enalapril (n=403)

dinitrate (n=401)

P

Deaths

Cumulative

Deaths

Cumulative

No. (%)*

mortality, %

No. (%)*

mortality, %

All

132

153

0.08

Other

11

7

* Percentage of cardiac deaths

Cohn et al. N Engl J Med 1991; 325:303–10.


V heft ii vasodilator heart failure trial results continued2
V-HeFT II: Vasodilator–Heart Failure Trial- RESULTS continued-

Mean change in left ventricular ejection fraction

Change in

0.05

ejection fraction

0.04

0.03

0.02

Enalapril

0.01

Hydralazine

isosorbide

0

dinitrate

13 weeks

1 year

2 years

Time after randomization

Cohn et al. N Engl J Med 1991; 325:303–10.


V heft ii vasodilator heart failure trial summary
V-HeFT II: Vasodilator–Heart Failure Trial- SUMMARY -

In patients with chronic congestive heart failure:

  • Enalapril conferred greater reduction in mortality than hydralazine–isosorbide for at least 2 years, due to lower incidence of sudden death

  • Treatment with either enalapril or hydralazine–isosorbide increased left ventricular ejection fraction

  • Hydralazine–isosorbide increased O2 consumption at peak exercise levels for the first year