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A Series of N-of-1 Trials and Mechanism Study on the Treatment of Heart Failure with Preserved Ejection Fraction Using Lu Hong Yixin Granules

A Series of N-of-1 Trials and Mechanism Study on the Treatment of Heart Failure with Preserved Ejection Fraction Using Lu Hong Yixin Granules

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000787
Enrollment
Unknown
Registered
2026-03-27
Start date
2025-05-21
Completion date
Unknown
Last updated
2026-04-28

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

Trial Period vs Control Period:Luhong Yixin Granules + conventional Western medicine treatment vs conventional Western medicine treatment

Sponsors

Anhui Province Jieshou City People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Meets the diagnostic criteria for HFpEF; (2) Age between 50-80 years old; (3) Overweight and obese HFpEF patients: BMI =25 kg/m², waist circumference =90 cm for men and =85 cm for women; (4) Voluntarily participates in the study and signs the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Severe cardiac structural/vascular diseases (severe valvular heart disease, severe coronary artery stenosis =50% within the past 2 months, etc.); (2) Hemodynamic instability (atrial fibrillation, sick sinus syndrome, second-degree or higher atrioventricular block, resting heart rate 5.5 mmol/L), and hematologic diseases; (5) Heart failure induced by reversible etiologies (e.g., hyperthyroidism, drugs, or toxins); (6) Combined moderate to severe hepatic and renal dysfunction (e.g., cholestatic cirrhosis, Child-Pugh grade B, ALT/AST >2 times the upper limit of normal, glomerular filtration rate (GFR) =30 mL/min/1.73 m²); (7) Combined acute complications (e.g., acute asthma exacerbation, body temperature >38.5°C with C-reactive protein >100 mg/L in infectious diseases); (8) Chronic wasting diseases (e.g., malignant tumors) and uncontrolled diabetes (HbA1c >7.0%); (9) Mental disorders that prevent cooperation with the study or allergy to components of the study drug.

Design outcomes

Primary

MeasureTime frame
Kansas City Cardiomyopathy Questionnaire-12;6-minute walking distance;—

Secondary

MeasureTime frame
N-terminal pro-brain natriuretic peptide;Echocardiography-related indicators: (1) E/e'; (2) Left Atrial Volume Index (LAVI); (3) Left Ventricular Mass Index (LVMI);—

Countries

China

Contacts

Public ContactYang Kun

Anhui Province Jieshou City People's Hospital

644328803@qq.com18955852885

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: May 1, 2026