Clinical Observation of Shengui Capsule Intervention in Heart Failure with Preserved Ejection Fraction

Dongzhimen Hospital, Beijing University of Chinese Medicine0 个研究点开始时间: 待定最近更新: 2023年2月20日

适应症

试验速览

暂无简介。

•? Patients with heart failure with preserved ejection fraction who meet the diagnostic criteria and have symptoms who need diuretics and whose cardiac function class (NYHA class) is II to IV;
•?Meet the 2019ESC diagnostic criteria for chronic coronary syndrome
•? The cause of heart failure in patients with preserved ejection fraction is caused by coronary heart disease;
•?Traditional Chinese medicine for heart failure patients with heart-yang insufficiency, qi deficiency and blood stasis;
•? Those who received at least 2 weeks of standardized western medicine treatment and reached the optimal dose;
•? Those who have not used traditional Chinese medicine/proprietary Chinese medicine for the treatment of heart failure within 2 weeks before enrollment;
•?Age between 40-80 years old;
•? Those who are in good spirits and able to communicate verbally and in writing;
•? The HFpEF patients who signed the informed consent form voluntarily participated in this study.

•? Under stable conditions, any previous echocardiographic measurement of LVEF = 50%;
•? Acute decompensated heart failure within 30 days prior to screening, or acute coronary syndrome (including myocardial infarction), cardiac surgery, other major cardiovascular surgery, or emergency percutaneous coronary intervention within 3 months prior to screening interventional therapy;
•? At the time of screening, walking distance was mainly limited by non-cardiac disease;
•? History of dilated cardiomyopathy, including perinatal cardiomyopathy, chemotherapy-induced cardiomyopathy or viral myocarditis;
•? History of hypertension and poor blood pressure control (systolic blood pressure = 160 mmHg, or diastolic blood pressure = 100 mmHg);
•? Patients with glycated hemoglobin>7.5% did not receive diabetes treatment;
•? Patients with serious primary diseases such as lung, brain, liver, kidney, hematopoietic system, mental illness, and severe neurosis;
•? Patients with Yin deficiency and Yang Sheng with symptoms such as burning skin, five upset hearts, shortness of breath, and constipation;
•?Allergic constitution or allergic to known components of the test drug.

发起方

Dongzhimen Hospital, Beijing University of Chinese Medicine