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

Phase 4

Not yet recruiting

• Conditions: heart failure with preserved ejection fraction

• Registration Number: ITMCTR2200005794
• Lead Sponsor: Dongzhimen Hospital, Beijing University of Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-02-20

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

? 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.

Exclusion Criteria

? 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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified