The trial enrolled adult HFrEF patients with a left ventricular ejection fraction of 40% or below and NT-proBNP of 450 pg/ml or higher who had been on a stable standardised baseline treatment regimen for at least two weeks prior to enrolment. Patients were randomised in a 1:1 fashion to receive qiliqiangxin (four capsules, three times daily) or a placebo on top of standard medications for chronic heart failure. The primary endpoint was a composite of rehospitalisation for worsening heart failure or cardiovascular death.

Assesment of Chinese Medicine Efficiency in Heart Failure Patients

A total of 3,110 patients were included in the analysis, with 1,555 randomised to qiliqiangxin and 1,555 randomised to placebo. The average age was 62 years and 72.1% were men. At baseline, the mean left ventricular ejection fraction was 32%, and the median NT-proBNP was 1730.80 pg/ml.

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During a median follow-up of 18.3 months, the primary endpoint occurred in 389 patients (25.02%) in the qiliqiangxin group and in 467 patients (30.03%) in the placebo group (hazard ratio [HR], 0.78; 95% confidence interval [CI], 0.68 to 0.90; p<0.001). This effect was related to both lower risks of rehospitalisation for worsening heart failure (HR, 0.76; 95% CI, 0.64 to 0.90; p=0.002) and cardiovascular death (HR, 0.83; 95% CI, 0.68 to 0.996; p=0.045) in the qiliqiangxin group.
The effect of qiliqiangxin on the primary outcome was generally consistent across prespecified subgroups including in the subgroups defined according to age and NT-proBNP level, and in patients with or without angiotensin receptor/neprilysin inhibitors (ARNIs).

In terms of secondary endpoints, the decrease in serum NT-proBNP between baseline and three-month follow-up was greater in the qiliqiangxin group (-444.00 [interquartile range -1401.00 to 85.00]) than in the placebo group (-363.00 [interquartile range -1280.00 to 183.00]) (p=0.047), which was consisted with the previous pilot study.

Analysis of safety endpoints demonstrated no significant difference in all-cause mortality, which occurred in 221 patients (14.21%) in the qiliqiangxin group and 262 patients (16.85%) in the placebo group (HR, 0.84; 95% CI, 0.70 to 1.01; p=0.058).

Qiliqiangxin capsules were well-tolerated, with no major differences between the two groups in adverse events including gastrointestinal symptoms, worsening renal function, and increased liver enzymes.

Reference :

1. QUEST: Traditional Chinese Medicine May Improve Major HF Outcomes
   – (https://www.acc.org/latest-in-cardiology/articles/2023/08/23/19/16/sat-230am-quest-esc-2023)

Source: Eurekalert