Clinical study of Shenshao tablet on improving exercise tolerance of patients with chronic ischemic heart failure (qi deficiency and blood stasis syndrome)

Phase 4

Recruiting

• Conditions: chronic ischemic heart failure (qi deficiency and blood stasis syndrome)

• Registration Number: ITMCTR2100004280
• Lead Sponsor: The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

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

Inclusion Criteria

1. According to the diagnostic criteria of chronic ischemic heart failure, refer to Chinese guidelines for the diagnosis and treatment of heart failure 2018:
(1)Previous history of myocardial infarction; coronary angiography or CT angiography showed at least one major coronary artery branch stenosis > 50%.
(2)LVEF < 50% or with symptoms / signs of heart failure.
(3)Coronary artery disease is closely related to heart failure.
2. In accordance with the diagnostic criteria of qi deficiency and blood stasis syndrome, refer to the technical guidelines for clinical research of new traditional Chinese medicine in chronic heart failure:
(1)Main symptoms: shortness of breath / wheezing, fatigue, palpitation.
(2)Secondary symptoms: a.languid and lazy speech, easy to work; b. spontaneous sweating; c.low voice; d.dark complexion / lips.
(3)Tongue vein: the tongue is dark (or with ecchymosis, ecchymosis or tortuous purplish vein under the tongue), the moss is thin and white, and the pulse is heavy, thin, astringent or ineffectual.
3. New York Heart Association (NYHA) cardiac function class II - IV;
4. The age ranged from 35 to 74 years;
5. Informed consent, volunteers.

Exclusion Criteria

1. Patients with chronic heart failure who need medical treatment in the near future;
2. Patients complicated with acute coronary syndrome (within 30 days), cardiogenic shock, acute myocarditis, hypertension (systolic blood pressure >= 180mmhg and / or diastolic blood pressure >= 110mmhg), malignant arrhythmia, hypertrophic obstructive cardiomyopathy, severe valvular disease requiring surgical treatment and pulmonary embolism, etc.;
3. Severe hepatic and renal insufficiency;
4. Severe anemia;
5. Psychopath;
6. Cancer patients;
7. Patients participating in drug clinical trials in recent months;
8. Pregnant or lactating women.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Veterans Specific Activity Questionnaire (VSAQ);

Secondary Outcome Measures

Name	Time	Method
BNP, NT-proBNP;ECG;major cardiovascular end point events;The Kansas city cardiomyopathy questionnaire (KCCQ);Traditional Chinese Medicine Syndrome Score;6 min walking distance test;NYHA cardiac function classification;cardiac ultrasound;TnI, TnT;CRP;AST, LDH, a-HBDH, CK, CK-MB;