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Determination of the sample size required to achieve a significant result is a key consideration in this study. Because we lack sufficient prior information regarding syndrome differentiation and treatment effects, a large number of participants needs to be enrolled to provide statistically reliable results. For these reasons, our target sample size is 50, Patients will be recruited from Chinese tertiary hospitals and one German hospital.
Recruitment of enough patients without delays lasting several years is critical in this study. The contingency activities including initiating backup hospitals and launching advertisements are well planned to ensure that a sufficient number of patients will eventually be included. It not only reduced systolic blood pressure but also improved diastolic blood pressure, which might lower the incidence of cardiovascular and cerebrovascular events.
Heart failure with a preserved ejection fraction can be attributed to palpitation, thoracic obstruction, edema, or other conditions according to its clinical manifestations. Ventricular remodeling is the inherent factor involved in the latent syndrome of heart failure, which is closely associated with blood stasis, and Yin asthenia can cause blood stasis, leading to the inability of heart Qi to promote the normal operation of blood in the vessel because of inadequate amounts of heart Qi and heart Yin.
The main treatment of heart failure with a preserved ejection fraction is replenishing Qi and nourishing Yin. Diagnosis and treatment in TCM are mainly based on syndrome differentiation. Multidisciplinary computational modeling approaches 43 — 48 have become valuable tools for diagnosis, therapy, and prevention of diseases in the clinical setting, but these tools have not been used in TCM syndrome differentiation to date.
Because correct syndrome differentiation is fundamental for effective treatment of diseases, this project is being performed to develop an application-oriented, machine-readable TCM Yin—Yang syndrome computer modeling system for cardiovascular disease with the aid of a noninvasive cardiac electrophysiology imaging technique.