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Evaluate the efficacy and safety of Dengzhan Shengmai Capsule in patients with Coronary heart disease complicated with heart failure with preserved ejection fraction:A multicenter, randomized, double-blind, placebo-controlled clinical trial

Evaluate the efficacy and safety of Dengzhan Shengmai Capsule in patients with Coronary heart disease complicated with heart failure with preserved ejection fraction:A multicenter, randomized, double-blind, placebo-controlled clinical trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300072852
Enrollment
Unknown
Registered
2023-06-27
Start date
2023-06-27
Completion date
Unknown
Last updated
2023-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary heart disease complicated with heart failure with preserved ejection fraction

Interventions

Control group:Dengzhan Shengmai Capsule Simulator

Sponsors

XiYuan Hospital of China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 85 Years

Inclusion criteria

Inclusion criteria: (1) Western medicine diagnosis conforms to the diagnostic criteria of chronic stable angina pectoris of coronary heart disease and heart failure with Ejection fraction preserved. The diagnosis is symptomatic heart failure and the history of heart failure exceeds 1 month; (2) The traditional Chinese medicine syndrome meets the standard of Qi and Yin deficiency combined with blood stasis syndrome; (3) Age 40-85 years old; (4) NYHA cardiac function grading II - IV (5) Voluntarily sign an informed consent form.

Exclusion criteria

Exclusion criteria: (1) Heart failure caused by valvular diseases, pericardial diseases, hypertrophic cardiomyopathy, myocardial Amyloidosis, Congenital heart defect, pulmonary diseases (COPD, pulmonary hypertension, etc.) and extracardiac diseases; (2) Patients with systolic blood pressure = 180mmHg or diastolic blood pressure>100mmHg; (3) Patients with Glucose test#Fasting blood sugar>13.9 mmol/L; (4) Acute or chronic liver diseases with severe liver function impairment (such as ascites, esophageal varices, coagulation disorders); Has renal function impairment (eGFR<25 mL/min/1.73 ?); Existence of active malignant tumors that require treatment (excluding basal cell or squamous cell skin cancer); (5) Patients with coagulation disorders; (6) Patients with acute cerebral hemorrhage; (7) Other diseases can explain the symptoms and signs of heart failure in patients (such as anemia and hypothyroidism); (8) Patients with absolute Contraindication and relative Contraindication of 6-minute walk test; (9) Pregnant women and lactating women; (10) Participated in other clinical trials within one month prior to enrollment; (11) Intravenous medication (including Diuretic) for heart failure within 12 hours before enrollment; (12) Individuals with allergic constitution or known allergies to investigational drugs.

Design outcomes

Primary

MeasureTime frame
six minutes walk test;

Secondary

MeasureTime frame
Kansas City Cardiomyopathy Questionnaire;New York Heart Association;diastolic function;NT-proBNP;Gal-3;Traditional Chinese Medicine Syndrome Score Scale;

Countries

China

Contacts

Public ContactDong Guo Ju

XiYuan Hospital of China Academy of Chinese Medical Sciences

13691393589@163.com+86 136 9139 3589

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026