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Clinical Efficacy Study of Network Core Prescription Based on Data Mining for Treating Patients with Heart Failure with Preserved Ejection Fraction

Clinical Efficacy Study of Network Core Prescription Based on Data Mining for Treating Patients with Heart Failure with Preserved Ejection Fraction

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400090310
Enrollment
Unknown
Registered
2024-09-27
Start date
2024-10-01
Completion date
Unknown
Last updated
2024-09-30

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

Conditions

Heart Failure with Preserved Ejection Fraction

Interventions

Control Group:Standard Western medical treatment will be administered for 12 weeks, followed by observation of therapeutic efficacy after 12 weeks
Experimental Group:On the basis of standard Western medical treatment, the experimental group will receive the core prescription Yixin Jiedu Formula (compound: Astragalus granules 30g, Salvia miltiorr
all Chinese herbs are uniformly prepared, one dose daily, orally/nasogastrically), administered for 12 weeks, with efficacy observed after 12 weeks.

Sponsors

Guangdong Provincial Hospital of Chinese Medicine (Main Hospital ICU)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Patients with Heart Failure with Preserved Ejection Fraction: ?Meet the diagnostic criteria for heart failure with preserved ejection fraction. ?Meet the diagnostic criteria for Qi deficiency and blood stasis syndrome in traditional Chinese medicine for heart failure. ?Age between 18 and 80 years old, any gender. ?Patients who have signed an informed consent form and are willing to undergo relevant examinations and treatments.

Exclusion criteria

Exclusion criteria: ?Patients with obstructive heart disease, constrictive pericarditis, cardiac tamponade, valvular heart disease, pulmonary embolism, severe and uncontrolled arrhythmias, or heart failure combined with uncontrolled infections; ?Patients with severe primary diseases of other internal medical systems such as liver, kidney, blood, and endocrine systems; ?Patients with mental disorders who cannot cooperate properly to complete the study; ?Pregnant and lactating women; ?Patients allergic to medications in this study protocol or specific components thereof; ?Patients unable to take medications as prescribed, affecting the assessment of efficacy, or patients with incomplete clinical data that cannot accurately assess the efficacy of drug treatment.

Design outcomes

Primary

MeasureTime frame
NT-proBNP change rate from baseline;

Secondary

MeasureTime frame
Cardiovascular death, heart failure readmission rate, or composite endpoint of emergency visits due to heart failure;Cardiac ultrasound: LVEF, E/E', LVMI, LVM, LAV, LAVI, LVDd, LVDs, E/A, TRV;6-minute walk test;KCCQ score;Traditional Chinese medicine syndrome score;Incidence rate of adverse events;

Countries

China

Contacts

Public ContactMaoshuai

The Second Clinical Medical College of Guangzhou University of Chinese Medicine, Guangdong Provincial Hospital of Chinese Medicine

maoshuai@gzucm.edu.cn+86 135 6032 1597

Outcome results

None listed

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