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Clinical study on the effect of Yiqi Fumai (freeze-drying) injection on myocardial compliance in patients with HFpEF

Clinical study on the effect of Yiqi Fumai (lyophilized) on myocardial compliance in patients with HFpEF

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000142
Enrollment
Unknown
Registered
2025-01-16
Start date
2025-02-05
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

HFpEF

Interventions

Treatment group:GDMT+5% Glucose solution 250ml+Yiqi Fumai (freeze-drying) injection 8 pieces
control group:GDMT+5% Glucose solution250ml

Sponsors

Jiangsu Province Hospital on Integration of Traditional Chinese and Western Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Meet the Western diagnostic criteria for HFpEF; (2) The cause of heart failure is ischemic heart disease; (3) Consistent with the main syndrome of qi and yin deficiency in traditional Chinese medicine; (4) Cardiac function is classified as NYHA functional class II-III; (5) Age range: 18-75 years old; (6) Stable clinical conditions during enrollment and randomization; (7) Enjoy the right to know and voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Acute coronary syndrome; (2) Active myocarditis or pericarditis; (3) Patients with severe heart failure and heart function grade IV; (4) Atrial fibrillation and diabetes were associated; (5) Planned extracardiac surgery; (6) Combined with serious diseases such as liver kidney malignant tumors endocrine system and hematopoietic system; (7) Individuals with mental disorders and unwillingness to cooperate; (8) Pregnant or lactating women; (9) Any factors that can increase mortality such as cardiogenic shock severe ventricular arrhythmia pericardial tamponade pulmonary embolism and severe infections.

Design outcomes

Secondary

MeasureTime frame
dp/dv;Six Minute Walk Distance;E/e';Traditional Chinese Medicine Syndrome Points;Serological indicators(sST2\NT-ProBNP\hs-CRP\IL-6\IL-11\Piezo1);Clinical efficacy evaluation of traditional Chinese medicine;E/A;

Primary

MeasureTime frame
?GLS;

Countries

China

Contacts

Public ContactLixing Wu

Jiangsu Province Hospital on Integration of Traditional Chinese and Western Medicine

wulixing@jsatcm.com13951775941

Outcome results

None listed

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