Efficacy and Safety of Qishenyiqi Dripping Pills for Treating Chronic Heart Failure With Preserved Ejection Fraction
NCT ID: NCT04944706
Last Updated: 2025-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
225 participants
INTERVENTIONAL
2021-07-27
2024-12-19
Brief Summary
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Detailed Description
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Exploratory research objective: To explore the changes of endogenous substances in vivo before and after drug administration, to interpret the mechanism of drug action through metabolomics and systems biology methods, and to find potential clinical biomarkers for exploratory subgroup analysis of clinical trials.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Low dose group
The standard basic treatment is given according to the guidelines related to the underlying disease
Qishen Yiqi dripping pills 2 bags/time + Qishen Yiqi dripping pills placebo 2 bags/time
Take 3 times a day after meals,24 weeks
High dose group
The standard basic treatment is given according to the guidelines related to the underlying disease
Qishen Yiqi dripping pills 4 bags/time
Take 3 times a day after meals,24 weeks
Placebo group
The standard basic treatment is given according to the guidelines related to the underlying disease
Qishen Yiqi dripping pills placebo 4 bags/time
Take 3 times a day after meals,24 weeks
Interventions
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Qishen Yiqi dripping pills 2 bags/time + Qishen Yiqi dripping pills placebo 2 bags/time
Take 3 times a day after meals,24 weeks
Qishen Yiqi dripping pills 4 bags/time
Take 3 times a day after meals,24 weeks
Qishen Yiqi dripping pills placebo 4 bags/time
Take 3 times a day after meals,24 weeks
Eligibility Criteria
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Inclusion Criteria
* Diagnosed as chronic heart failure with preserved ejection fraction according to the Guidelines for Diagnosis and Treatment of Heart Failure in China 2018
1. Have symptoms and/or signs of chronic heart failure at least 30 days before the trial
2. LVEF≥50% according to echocardiography during screening stage
3. BNP \> 35 ng/L and/or NT-proBNP \> 125 ng/L
4. Cardiac structural changes or diastolic dysfunction according to echocardiography during screening stage, in line with at least one of the following:
1. : LAVI\>34ml/m2
2. : E/e'≥13
3. : average e'(interventricular septum and free wall)\<9cm/s
* NYHAⅡ-Ⅲ
* Patients with hypertension received a stable dose of antihypertensive therapy for at least 4 weeks and kept their blood pressure at an ideal level for at least 4 weeks
* 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
1. Patients with acute decompensated heart failure who need to use quick-acting diuretics, vasodilators, or positive inotropic drugs for treatment, or in the adjustment period of acute decompensated heart failure treatment, and the adjustment time is less than 1 month
2. Clinical evidence of acute coronary syndrome (including myocardial infarction, unstable angina pectoris) within 6 months before screening stage
3. Received prior revascularization (such as PCI, CABG), or implantable cardioverter defibrillator (ICD), or other cardiac/cardiovascular procedures within 3 months before screening stage
4. Received cardiac resynchronization therapy (CRT) within 6 months before screening stage
5. Implantable devices (e.g. ICD, CRT), revascularization (e.g. PCI, CABG), or other cardiac/cardiovascular procedures are expected to be performed during the trial period
6. Patients with acute myocarditis, invasive cardiomyopathy, constrictive pericarditis, cardiac tamponade, hypertrophic obstructive cardiomyopathy, cardiac shock, hemodynamic abnormalities of heart valve disease significantly narrow and/or regurgitation (moderate or above, etc.), Ⅱ degrees above Ⅱ type atrioventricular block placement pacemaker therapy, average QTc \> 450 ms or heart rate \< 50 times/min
7. Patients with pulmonary artery embolism caused by pulmonary hypertension, chronic obstructive pulmonary disease and other serious pulmonary diseases
8. Hypertension that is difficult to control with medication (systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg)
9. Symptomatic hypotension and/or systolic blood pressure \<100 mmHg
* Severe renal insufficiency: eGFR \< 30 ml/min/1.73m2
* ALT and AST \> 3 times upper the limit of normal values in local laboratories, and/or total bilirubin \> 2 times upper the limit of normal values in local laboratories
* Serum potassium ≥5.5 mmol/L
* HbA1c≥9.0%, or fasting blood glucose \>13.9 mmol/L
* Diabetic patients who are using sodium-glucose cotransporter 2 inhibitors and cannot stop using them during the trial, such as dagliredin, entagliredin, and cagliredin
* The ECG examination indicated the onset of atrial fibrillation during the screening period or previous history of atrial fibrillation within 6 months before screening stage
* Hemoglobin \< 9.0 g/dL
* Patients have stroke 3 months before the screening period
* Concomitant mental illness and poor condition control, which affects the signing of informed consent or presentation of adverse events
* Patients with active malignancies (including those currently under oncology treatment)
* Unable to conduct the 6-minute walking distance test due to physical impairment or other non-cardiac reasons
* Women who are pregnant or lactating
* Allergic constitution, or allergic to the test drug or its ingredients
* Participate in clinical trials of other drugs within 3 months before screening
* The researchers did not consider it appropriate to participate in this study
18 Years
ALL
No
Sponsors
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Tasly Pharmaceutical Group Co., Ltd
INDUSTRY
Responsible Party
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Locations
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The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
Beijing Hospital
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, China
Peking University People's Hospital
Beijing, Bejing, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Hebei General Hospital
Shijiazhuang, Hebei, China
The Third Affiliated Hospital of Xinxiang Medical College
Xinxiang, Henan, China
The third Xiangya Hospital of Central South University
Changsha, Hunan, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Zhongda Hospital Southeast University
Nanjing, Jiangsu, China
China Japan Union Hospital of Jilin University
Changchun, Jilin, China
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Nei Monggol Autonomous Region, China
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
The Second Affiliated Hospital Of Xi'an Jiaotong University
Xi’an, Shanxi, China
Tianjin Chest Hospital
Tianjin, Tianjin Municipality, China
Countries
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Other Identifiers
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TSL-TCM-QSYQDW-HFpEF-Ⅱ
Identifier Type: -
Identifier Source: org_study_id
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