Impact of ShengXian-QuYu Decoction on Symptoms and Quality of Life in Adults with Heart Failure and Reduced Ejection Fraction A Nationwide, Randomized, Double-Blind, Placebo-Controlled Phase 4 Trial

What this Trial Is About

Researchers are evaluating the effect of ShengXian-QuYu Decoction on quality of life, symptoms, and biomarkers in patients with heart failure who have reduced or mildly reduced ejection fraction. This is a nationwide, multicenter, randomized, double-blind, placebo-controlled clinical trial designed to assess this traditional Chinese medicine compared to a placebo alongside standard care. The trial will also analyze results within subgroups based on factors like heart failure characteristics, comorbidities, and baseline biomarkers. Participants will be randomly assigned to receive either the ShengXian-QuYu Decoction or a placebo, both given orally twice daily. The decoction contains specific herbal ingredients including Astragalus membranaceus and Panax ginseng, among others. The study treatment is added to each patients usual care, and the effects will be monitored over a 12-week period, with some measures extending up to 26 weeks. During the study, participants will undergo various assessments including quality of life questionnaires, symptom scoring based on Traditional Chinese Medicine standards, exercise capacity tests, and measurement of heart function and kidney filtration. Biomarkers such as N-terminal pro-brain natriuretic peptide will also be tracked. Safety and adherence will be monitored throughout the study, which started in March 2023 and is expected to complete by the end of 2025.

SHengXIaN-QuYu DEcoction in Heart Failure With Reduced and Mildly Reduced Ejection Fraction