A Single-Central, Randomized, Double-Blinded, Placebo-Controlled, Crossover Trial Protocol: A Clinical Effect...

Area of Science:

• Cardiology
• Integrative Medicine
• Pharmacology

Background:

• Chronic heart failure (CHF) presents high morbidity and mortality rates globally.
• Traditional Chinese Medicine (TCM) offers a promising comprehensive intervention for CHF management.
• Existing research indicates potential efficacy, necessitating further clinical validation.

Purpose of the Study:

• To evaluate the safety and efficacy of a TCM comprehensive intervention in patients diagnosed with CHF.
• To assess the impact of TCM on cardiac function, quality of life, and relevant biomarkers.
• To provide robust evidence for integrating TCM into standard CHF care.

Main Methods:

• A randomized, single-center, placebo-controlled, double-blinded crossover trial involving 82 eligible CHF patients (aged 18-75).
• Participants received either Qishen Taohong granules (QTGs) with TCM external treatment and Western medicine, or placebo, followed by a crossover.
• Outcomes included NYHA classification, echocardiography, NT-proBNP, CHFQLS, TCM syndrome, 6MWT, PSQI, MoCA, MACEs, and metabolomics.

Main Results:

• The study is designed to collect data on various efficacy endpoints, including cardiac function and quality of life metrics.
• Analysis will focus on comparing the effects of TCM comprehensive intervention against placebo and standard care.
• Biomarker analysis (NT-proBNP, metabolomics) will provide insights into the underlying mechanisms of action.

Conclusions:

• The TCM comprehensive intervention is hypothesized to improve cardiac function and enhance the quality of life for CHF patients.
• This study aims to generate high-quality evidence supporting the use of TCM in CHF treatment.
• Findings could inform clinical guidelines and promote the integration of TCM in cardiovascular disease management.