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A Prospective Cohort Study on the Treatment of Elderly Patients with Heart Failure with Preserved Ejection Fraction and Frailty Using Yiqi Fumai Injection

A Prospective Cohort Study on the Treatment of Elderly Patients with Heart Failure with Preserved Ejection Fraction and Frailty Using Yiqi Fumai Injection

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ITMCTR
Registry ID
ITMCTR2025000176
Enrollment
Unknown
Registered
2025-01-25
Start date
2024-12-01
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

Elderly Heart Failure with Preserved Ejection Fraction (HFpEF) and Frailty

Interventions

"Exposed group":On the basis of the control group an additional treatment of Yiqi Fumai Injection (manufactured by Tianjin Tasly-Tjq Pharmaceutical Co. Ltd. National Medical Products Administration Ap
"Non-exposed group":Based on the "2023 Chinese Expert Consensus on Diagnosis and Treatment of Heart Failure with Preserved Ejection Fraction (HFpEF)" and the "2022 Chinese Expert Consensus on Preventi

Sponsors

The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1) Meeting the diagnostic criteria for heart failure with preserved ejection fraction (HFpEF) and frailty (FRAIL scale score = 3); 2) Age between 60 and 90 years regardless of gender; 3) New York Heart Association (NYHA) functional classification of heart failure II to III; 4) Patients who have provided informed consent and signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1) Patients with chronic heart failure who recently require instrumental therapy; 2) Patients with acute coronary syndrome (within 30 days) cardiogenic shock acute myocarditis uncontrolled hypertension (systolic blood pressure = 180mmHg and/or diastolic blood pressure = 110mmHg) uncontrollable malignant arrhythmia hypertrophic obstructive cardiomyopathy severe valvular heart disease requiring surgical treatment pulmonary embolism etc.; 3) Patients with severe hepatic and renal insufficiency; 4) Patients with severe anemia; 5) Patients with severe mental illness malignant tumors or other uncontrolled systemic diseases; 6) Patients who have participated in drug clinical trials in the past month; 7) Patients with suspected or confirmed allergies to the study drug.

Design outcomes

Primary

MeasureTime frame
6-minute walk distance;

Secondary

MeasureTime frame
Kansas Heart Failure Questionnaire;NT-pro BNP/BNP;Frailty Index;E/e';

Countries

CHINA

Contacts

Public ContactLV Shichao

The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

dr_lv@foxmail.com13920127740

Outcome results

None listed

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