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Treatment of heart failure with preserved ejection fraction with combination of western medicine and Yangyin Shuxin prescription: a single-center, single-blind, randomized, controlled clinical trial

Phase 1
Completed
Conditions
heart failure with preserved ejection fraction
Registration Number
ITMCTR2000003147
Lead Sponsor
The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

1. Symptoms±Signs of heart failure; LVEF>=45%; LVH/LAE/diastolic dysfunction
2. Aged 18 to 79 years;
3. NYHA classification I to III;
4. Sign the informed consent form.

Exclusion Criteria

1. ACS;
2. Aortic Dissection;
3. Fatal arrhythmia;
4. Acute Heart Failure;
5. Hypertension that cannot be controlled well;
6. Atrial fibrillation/Atrial flutter;
7. Advanced atrioventricular block;
8. Pericardial Diseases;
9. Valvular Disease;
10. Cardiomyopathy;
11. pulmonary embolism;
12. PAH;
13. Stroke in the past 3 months/Unfavorable unilateral limb movements due to Stroke;
14. Mental disease;
15. Moderate to severe anemia(HGB<90g/L);
16. Severe hepatic and renal dysfunction(ALT>3 times the normal upper limit, Cr>3mg/dl);
17. People with allergies or known to be allergic to this medicine and ingredients;
18. Disability in the lower limbs or inability to cooperate for various reasons;
19. Women who are preparing for pregnancy, childbearing or breastfeeding in the last 3 months;
20. Participated in other clinical trials in the past 3 months;
21. The survival period not exceeding 3 months;
22. Patients could not complete the study or could not comply with the requirements of the study.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
GLS;UT;Peak VO2;LAVI;
Secondary Outcome Measures
NameTimeMethod
VEF;E/e';
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