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Recombinant human neuregulin-1 associated with slight improvement in cardiac function, ventricular remodeling

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The administration of recombinant human neuregulin-1 in patients with chronic HF was associated with modest improvements in left ventricular ejection fraction, end systolic volume and end diastolic volume when compared with pretreatment.

Researchers enrolled 44 patients with chronic HF in the study and randomly assigned them to receive either recombinant human neuregulin-1 (0.3 mcg/kg per day, n=11; 0.6 mcg/kg per day, n=11; or 1.2 mcg/kg per day, n=10) or placebo (n=11). The primary endpoint was the percent change in LVEF, end systolic volume or end diastolic volume as assessed by MRI at 11, 30 and 90 days. Secondary efficacy endpoints included changes in NYHA functional class, six-minute walk test, quality of life score and plasma NT-proBNP natriuretic peptide levels.

According to the study results, there was no significant difference in cardiac functionality as measured by MRI between the study groups. There was, however, an increase in the percent change in LVEF in the group treated with 0.6 mcg/kg per day of recombinant human neuregulin-1 vs. placebo (12%, P=.12), which become more significant by day 30 (increase of 27.11%, P=.009). The change in LVEF also remained at a high level at day 90 (increase of 31.99%, P=.02). A time-dependent decrease in end systolic and end diastolic volumes in the 0.3 mcg/kg per day and 0.6 mcg/kg per day groups was also reported. By day 30, end systolic volume had decreased by 5.33% and end diastolic volume by 3.28%; by day 90, end systolic volume had decreased by 12.10% and end diastolic volume by 8.07%.

The most effective dose for inhibition of cardiac enlargement, according to the results, was 0.6 mcg/kg per day. There were no significant differences between study groups for the secondary endpoints other than an inhibition of elevated NT-proBNP levels in the 0.3 mcg/kg per day and 0.6 mcg/kg per day treatment groups.

“Short-term administration of recombinant human neuregulin-1 (0.6 mcg/kg per day) in chronic HF patients could result in sustained improvement of cardiac pumping and inhibition or reversal of ventricular remodeling compared with baseline, although these changes were not statistically significant between [the treatment] groups,” the researchers wrote in their conclusion.

Gao R. J Am Coll Cardiol. 2010;55:1907-1914.

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