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Efficacy and safety evaluation of Lingguizhugan Decoction in treating HFmrEF: a study protocol of a randomized controlled trial

Efficacy and Safety Evaluation of Lingguizhugan Decoction in Treating Heart Failure With Mid Range Ejection Fraction

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000034300
Enrollment
Unknown
Registered
2020-07-01
Start date
2020-06-30
Completion date
Unknown
Last updated
2021-05-17

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

Conditions

heart failure with mid range ejection fraction

Interventions

Sponsors

Hospital of Chengdu University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 18-75 years; 2. Newly discovered patients with chronic heart failure are treated with stable and standardized guidelines for more than 3 months; 3. Meet the diagnostic conditions of HFmrEF: (1) Have symptoms and/or signs of heart failure; (2) LVEF40%49%; (3) Increased natriuretic peptide levels (B-type brain natriuretic peptide, BNP >= 35 pg/ml or N-terminal BNP precursor, NT-proBNP >=125 pg/ml) (4) Related structural heart diseases: left ventricular hypertrophy (male left ventricular mass index >= 115g/m2, female >= 95g/m2) or left atrial enlargement (left atrial volume index > 34ml/m2) or diastolic dysfunction. 4. After more than two weeks of the washout period of Chinese medicine/Chinese patent medicine; 5. Heart failure caused by hypertension and underlying coronary heart disease; 6. Patients with cardiac function grade NYHA II/III; 7. Agree and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Heart failure is accompanied by severe heart valve disease, congenital heart disease, pericardial disease, cardiomyopathy, acute cardiovascular events in the past month, unstable angina, acute myocarditis and infective endocarditis; 2. Cerebrovascular accident and severe pulmonary vascular disease occurred in the last 6 months; 3. Severe liver and kidney dysfunction, in which creatinine > 265µmol/L 4. Merging serious diseases or malignant tumors of other systems; 5. Women who are pregnant or breastfeeding or have recent birth planning; 6. People with allergies, mental illnesses and infectious diseases; 7. Acute infection, sepsis and sepsis; 8. Known intolerance to long-term use of Chinese medicine; 9. Patients who are participating or have participated in other clinical trials within the past three months; 10. The investigator believes that it is not appropriate to participate in other conditions of this experiment.

Design outcomes

Primary

MeasureTime frame
Left ventricular ejection fraction;N-Terminal pro-brain natriuretic peptide (NT-proBNP);adverse cardiovascular events;Six-minute walk test;NYHA functional class;

Secondary

MeasureTime frame
Electrocardiogram;SF-36 Quality of Life Questionnaire;blood routine examination;routine urine examination;liver faction examination;blood pressure;

Countries

China

Contacts

Public ContactXueping Li

Hospital of Chengdu University of Traditional Chinese Medicine

lixueping@cdutcm.edu.cn+86 13880415531

Outcome results

None listed

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