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Clinical Study on Improving Myocardial Energy Metabolism and Inhibiting Ventricular Remodeling in Patients with Heart Failure with Reduced Ejection Fraction by Shexiang Baoxin Pill

Clinical Study on Improving Myocardial Energy Metabolism and Inhibiting Ventricular Remodeling in Patients with Heart Failure with Reduced Ejection Fraction by Shexiang Baoxin Pill

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400090946
Enrollment
Unknown
Registered
2024-10-16
Start date
2022-06-24
Completion date
Unknown
Last updated
2024-10-21

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

Conditions

Heart Failure

Interventions

Shexiang Baoxin Pill group :two pills of SBP (Shanghai Hutchison Pharmaceuticals, 22.5 mg/pill) each time, three times a day
placebo group :two pills of placebo(Shanghai Hutchison Pharmaceuticals, 22.5 mg/pill) each time, three times a day

Sponsors

Anqing Municipal Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) age>=18 years old, <=75 years old, gender unlimited; 2) confirmed as chronic heart failure according to the 2018 Chinese Guidelines for the Diagnosis and Treatment of Heart Failure; 3) HFrEF was confirmed by cardiac ultrasound, and the NYHA cardiac function grade was between grade II~III 4) the subjects voluntarily participated in this study and have signed an informed consent form.

Exclusion criteria

Exclusion criteria: 1) Patients with acute myocardial infarction (within 3 months), acute heart failure, and recent unstable angina pectoris; 2) Individuals who have recently used drugs that affect immune responses, such as corticosteroids. 3) Recent inflammatory reactions such as fever, redness, swelling, pain, rash and other acute and chronic infectious diseases; 4) Patients with combined left ventricular outflow tract obstruction; 5) Combined myocarditis; 6) Uncontrolled severe arrhythmia; 7) Combined aortic aneurysm; 8) Merge severe liver, kidney, hematological, psychiatric or systemic diseases; 9) Significant liver and kidney dysfunction (ALT>2.0 times the upper limit of normal value; blood creatinine>1.5 times the upper limit of normal value); 10) Serum potassium>5.5mmol/L; 11) Uncontrolled hypertension (above 180/110mmHg); 12) Pregnant or lactating women; 13) Allergic to Shexiang Baoxin Pill; 14) Participate in clinical studies of other drugs.

Design outcomes

Primary

MeasureTime frame
Serum free fatty acid;Left ventricular end diastolic volume;Left ventricular end systolic volume;Left ventricular ejection fraction;Left ventricular ejection time;left ventricular stroke volume;myocardial energy expenditure;

Secondary

MeasureTime frame
N-terminal precursor of brain natriuretic peptide;Major Adverse Cardiovascular Events;Arrhythmia;

Countries

China

Contacts

Public ContactPei Nie

Anqing Municipal Hospital

niepei2022@163.com+86 183 1536 6061

Outcome results

None listed

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