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Effectiveness and mechanism of Huoxin pill on heart failure after percutaneous coronary intervention: Study protocol
Bo-Yong Qiu1, Bai-Rong Xu1, Yan-Kun Song1
1Heart Center/National Regional (Traditional Chinese Mdicine) Cardiovascular Diagnosis and Treatment Center, The First Affiliated Hospital of Henan University of CM, Zhengzhou, Henan, China.
Insights
This clinical trial investigates Huoxin pill (HXP) for heart failure (HF) after percutaneous coronary intervention (PCI). Multi-omics analysis will explore HXP
Area of Science:
- Cardiovascular Medicine
- Pharmacology
- Genomics
- Proteomics
- Metabolomics
Background:
- Coronary heart disease (CHD) is a leading cause of cardiovascular disease globally.
- Cardiac remodeling is a key pathological process in the progression of heart failure (HF) post-CHD.
- Existing treatments for HF often lack comprehensive evidence, particularly from traditional Chinese medicine like Huoxin pill (HXP).
Purpose of the Study:
- To evaluate the efficacy of Huoxin pill (HXP) in treating heart failure (HF) following percutaneous coronary intervention (PCI).
- To elucidate the underlying mechanisms of HXP in mitigating cardiac remodeling using multi-omics techniques.
- To provide evidence-based support for the use of HXP in managing CHD and HF.
Main Methods:
- A randomized, double-blind, placebo-controlled trial involving 60 patients with HF undergoing PCI.
- Participants will receive either conventional treatment plus HXP or a placebo.
- Outcomes include NYHA cardiac function grade, Lee's HF score, exercise tolerance, quality of life, cardiac ultrasound, ECG, and biochemical markers.
Main Results:
- This section is to be populated upon study completion.
Conclusions:
- This study aims to establish HXP as a potential therapeutic option for HF post-PCI.
- Findings are expected to offer mechanistic insights into HXP's effects on cardiac remodeling.
- The trial may contribute to evidence-based integration of traditional Chinese medicine in cardiovascular care.
Background:
Coronary heart disease (CHD) is the most common cardiovascular disease facing human beings. Cardiac remodelling is an important pathological factor for the progression of heart failure (HF) after CHD. At present, Chinese medicine is widely used in the treatment of HF, but there are still some drugs lack of evidence-based and mechanism evidence. Multi-omics techniques can deep explore candidate pathogenic factors and construct gene regulatory networks.This trial is intended to evaluate the effect on Huoxin pill (HXP) in the treatment of HF after programmable communication interface (PCI). Meantime, multi-omics analysis technique will be used to target the fundamental pathological links of cardiac remodelling, so as to study the mechanism of HXP in the treatment of HF after PCI.
Methods:
This study is a randomized, double-blind, placebo-controlled trial. Sixty patients with HF undergoing PCI are recruited from the First Affiliated Hospital of Henan University of CM. All selected patients will be randomly attributed to receive conventional treatment + HXP or placebo. The packaging, dosage and smell of placebo and heart activating pill were identical. The primary outcome is NYHA cardiac function grade, while the secondary outcomes included Lee's HF score, exercise tolerance test, and quality of life evaluation. Additional indicators include cardiac ultrasound, electrocardiogram, 24-h dynamic electrocardiogram, myocardial injury indicators, and energy metabolism indicators.
Discussion:
This study may provide a new treatment option for patients with HF after PCI and provide evidence for the treatment of CHD and HF with HXP.
Trial Registration:
2023-10-08 registered in China Clinical Trial Registry, registration number ChiCTR2300076402.
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