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NCT Number: NCT04983043

Efficacy and Safety of QiShen YiQi Dripping Pills in Chronic Heart Failure

This study will evaluate the efficacy and safety and the best effective dose of QiShen YiQi Dripping Pills in the treatment of chronic heart failure with decreased ejection fraction of CHD (Qi deficiency and blood stasis syndrome).

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Key information

Conditions

Chronic Heart Failure With Reduced Ejection Fraction

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hefei First People's Hospital, Hefei, Anhui, China

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About this study

QiShen YiQi Dripping Pills are oral, compound traditional chinese medicine prepatations. This study will evaluate the efficacy and safety and the best effective dose of QiShen YiQi Dripping Pills in the treatment of chronic heart failure with decreased ejection fraction of CHD (Qi deficiency and blood stasis syndrome).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Conformed to the diagnostic criteria of CHD and chronic heart failure
  • Conformed to the TCM syndrome differentiation standard of chronic heart failure syndrome of Qi deficiency and blood stasis
  • Male or female subjects aged ≥ 40 years and ≤80 years
  • LVEF<45%(modified Simpson method)
  • NYHAⅡ-Ⅲ
  • Received standardized drug therapy for chronic heart failure at least 2 weeks before randomization, and did not receive intravenous therapy (vasoactive drugs, diuretics) within 2 weeks without adjustment of dose
  • Ability to understand the requirements of the study and willingness to provide written informed consent
  • Have no pregnancy program and take effective contraceptive measures voluntarily
  • Abide by the experimental protocol and cooperate with the data collection according to the researcher's judgment

Exclusion criteria

  • Patients with heart failure caused by other heart diseases,such as cor pulmonale, congenital heart disease, primary pulmonary hypertension, secondary severe pulmonary hypertension, severe stenosis or insufficiency of heart valves, cardiomyopathy (including hypertrophic cardiomyopathy, restrictive cardiomyopathy, dilated cardiomyopathy, alcoholic cardiomyopathy), moderate massive pericardial effusion, constrictive pericarditis, infective endocarditis
  • Heart failure caused by systemic diseases or other systemic diseases, such as rheumatic immune and secretory diseases;heart failure caused by kidney disease, lung disease, liver disease and serious infection;heart failure caused by chemical or toxicological causes
  • Patients who had acute myocardial infarction, underwent coronary revascularization or left ventricular remodeling, underwent cardiac resynchronization with pacemaker implantation, underwent cardiothoracic surgery within 3 months prior to receiving the experimental drug, patients with other acute coronary syndrome, pulmonary embolism or acute cerebrovascular disease
  • Severe arrhythmias such as ventricular tachycardia, second degree Ⅱ type or above sinus atrial or atrioventricular block without pacemaker treatment, average QTc > 500ms, heart rate < 50 beats/min, etc
  • Complicated with other serious diseases, such as pheochromocytoma, hematologic diseases, organ transplantation patients, and any history of malignant tumor
  • The presence of uncontrolled hypertension, systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg
  • Hypotension with a systolic blood pressure <80mmHg and/or a diastolic blood pressure <50mmHg
  • Patients with hepatic and/or renal dysfunction (ALT≥ 2 times the upper limit of normal, and/or estimated glomerular filtration rate (EGFR) <30 mL /min/1.73m2
  • HbA1c ≥9.0%, or fasting blood glucose ≥13.9mmol/L
  • Moderate and severe anemia (Hb < 90g/L)
  • Serum potassium ≥5.5mmol/L
  • Patients requiring anticoagulants who did not achieve dose stabilization for 1 month or INR > 3.0
  • In patients who need to take antiplatelet drugs, the dose was stable for less than 1 month, and the platelet value was lower than the lower limit of normal value
  • Allergic to the test drug or its related taste or ingredients
  • People with complicated mental illness, poor condition control and drug addiction
  • Unable to complete 6MWT
  • Pregnant or lactating women
  • Participation in other studies and use of investigational drugs from other studies within 3 months prior to screening
  • The investigator deems that the patient is not suitable to participate in the study, including the investigator's judgment that the patient is unable to complete the study or comply with the requirements of the study

Treatment and study plan

Low dose QiShen YiQi Dripping Pills 3 bags

Drug

Low dose QiShen YiQi Dripping Pills contain QiShen YiQi Dripping Pills 2 bags(0.52g dripping pills per bag) and QiShen YiQi Dripping Pills placebo 1 bag(0.52g dripping pills placebo per bag),take orally after meals, 3 times a day for 12weeks

Other names: Low dose group

High dose QiShen YiQi Dripping Pills 3 bags

Drug

High dose QiShen YiQi Dripping Pills contain QiShen YiQi Dripping Pills 3 bags(0.52g dripping pills per bag),take orally after meals, 3 times a day for 12weeks

Other names: High dose group

QiShen YiQi Dripping Pills placebo 3 bags

Drug

QiShen YiQi Dripping Pills placebo contain QiShen YiQi Dripping Pills placebo 3 bags(0.52g dripping pills placebo per bag),take orally after meals, 3 times a day for 12weeks

Other names: Placebo group

Primary outcomes

  1. 6-Minutes-Walking-Test (6MWT) in week 12

    Time frame: Baseline to weeks 12

    Change from baseline to weeks 12 in exercise capacity as measured by the 6-Minutes-Walking-Test (6MWT) distance.

Secondary outcomes

  1. 6-Minutes-Walking-Test (6MWT) in weeks 4 and 8

    Time frame: Baseline to weeks 4 and 8

    Change from baseline to weeks 4 and 8 in exercise capacity as measured by the 6-Minutes-Walking-Test (6MWT) distance.

  2. NYHA classification

    Time frame: Baseline to weeks 4,8 and 12

    Percentage of subjects whose NYHA classification improved/worsened/remained unchanged from baseline to weeks 4,8 and 12.

  3. Traditional Chinese Medicine Syndrome Score

    Time frame: Baseline to weeks 4,8 and 12

    Change from baseline to weeks 4,8 and 12 in Traditional Chinese Medicine Syndrome Score. There were 3 clinical primary symptoms, 4 clinical secondary symptoms, tongue picture and pulse condition evaluated as TCM symptoms, which was defined as TCM syndrome score. The standard of TCM primary symptoms scored as without 0, light 2, medium 4, heavy 6 points. The standard of TCM secondary symptoms scored as without 0, with 1 points. Tongue picture and pulse condition did not count.

  4. Dyspnea, weakness, edema

    Time frame: Baseline to weeks 4,8 and 12

    Symptom disappearance rate(dyspnea, weakness, edema) from baseline to weeks 4,8 and 12.

  5. Echocardiogram results

    Time frame: Baseline to weeks 4,8 and 12

    • Change from baseline to weeks 4,8 and 12 in left ventricular end diastolic diameter(LVEDD) measured by echocardiography;
    • Change from baseline to weeks 4,8 and 12 in left ventricular end diastolic volume(LVEDV) measured by echocardiography;
    • Change from baseline to weeks 4,8 and 12 in left ventricular end systolic volume(LVESV) measured by echocardiography;
    • Change from baseline to weeks 4,8 and 12 in left ventricular ejection fraction(LVEF) measured by echocardiography;
    • Change from baseline to weeks 4,8 and 12 in stroke volume(SV) measured by echocardiography;
    • Change from baseline to weeks 4,8 and 12 in cardiac output(CO) measured by echocardiography.

  6. NT-proBNP

    Time frame: Baseline to weeks 4,8 and 12

    Change from baseline to weeks 4,8 and 12 in NT-proBNP.

  7. Minnesota Living With Heart Failure Questionnaire(MLHFQ)

    Time frame: Baseline to weeks 4,8 and 12

    Change from baseline to weeks 4,8 and 12 in Minnesota Living With Heart Failure Questionnaire(MLHFQ). The MLHFQ is a self-administered questionnaire for patients with HF, comprising 21 items representing different degrees of impact of HF on health-related quality of life. Every item in this questionnaire scores from 0 (none) to 5 (very much) and the total items score from 0 (none) to 105 (very much).

  8. Cardiovascular adverse events

    Time frame: Week 12

    To determine whether the incidence of cardiovascular adverse events during the study period was superior to placebo.

Other outcomes

  1. Saturation of Peripheral Oxygen

    Time frame: Week 12

    To determine whether the saturation of peripheral oxygen is improved from baseline to week 12 after treatment.

  2. Grasp strength body mass index test

    Time frame: Week 12

    To determine whether the grasp strength body mass index is improved from baseline to week 12 after treatment.

Sponsors and collaborators

Lead sponsor

Tasly Pharmaceutical Group Co., Ltd

Industry

Registry information

Official study title

A Multi-center, Randomized, Double-blind, Placebo-parallel Controlled, Standardise-loaded Ⅱ Clinical Trial of Efficacy and Safety of QiShen YiQi Dripping Pills in Chronic Heart Failure

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jul 30, 2021
Registry last updated
Jan 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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