Study Protocol: Traditional Chinese Medicine (TCM) Syndrome Differentiation for Heart Failure patients and its Implication for Long-term Therapeutic Outcome of Qiliqiangxin Capsules

Abstract

\n BackgroundSyndrome differentiation is a commonly used methodology and practice in Traditional Chinese Medicine (TCM) guiding the diagnosis and treatment of diseases including heart failure (HF). However, previous clinical trials seldom consider the impact of syndrome patterns on the outcome evaluation of TCM formulae. Qiliqiangxin (QLQX) capsule is a TCM formula with cardiotonic effect to improve the cardiovascular function for heart failure with proven efficacy from well-designed clinical trials. Though, there is no clinical trial with a large sample size and long assessment period that considers the relationship between TCM syndrome differentiation and the treatment efficacy of QLQX. In the present study, we design a study protocol to evaluate the relationship between TCM syndrome differentiation and the severity of heart failure as well as its progression. Furthermore, we will evaluate the impact of the TCM syndrome patterns on the efficacy of QLQX in the outcome of heart failure. MethodsThis is a clinical study conducted in conjunction with an ongoing clinical trial (QUEST Study 1 ) to evaluate the efficacy of QLQX to improve the outcome of HF treatment through the assessment of morbidity and re-hospitalization, which involves over 100 hospitals in mainland China and Hong Kong SAR with 3,080 HF patients. Firstly, we will apply a modified TCM Questionnaire to collect the clinical manifestations of HF and acquire the tongue images of the patients to facilitate the syndrome differentiation. We will base on the “2014 Consensus from TCM experts on diagnosis and treatment of chronic heart failure” to evaluate the TCM syndromes for the patients. Secondly, we will investigate the characteristic of TCM syndrome distribution of HF patients and its correlation with the functional and biochemical data. Furthermore, we will evaluate the relationship between the TCM syndrome patterns and the efficacy of QLQX in the treatment of heart failure. Lastly, we will investigate the implication of tongue diagnosis in the severity and therapeutic outcome of HF. Expect OutcomesTo our knowledge, this will be the latest and well-designed clinical trial to evaluate the rules of TCM syndrome differentiation in the progression and therapeutic outcome of HF patients. We expect to obtain direct clinical evidence to verify the importance of TCM syndrome differentiation for the diagnosis and treatment of HF.Trial Registration1The trial was registered at Chinese Clinical Trial Registry, http://www.chictr.org.cn. (Registration No.: ChiCTR1900021929); Date: 2019-03-16.