Efficacy and Safety of Qishenyiqi Dripping Pills for Treating Chronic Heart Failure With Preserved Ejection Fraction

NCT04944706 | Completed Phase 2

• 1 other identifier: TSL-TCM-QSYQDW-HFpEF-Ⅱ
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 16

Brief Summary

Main objective: To evaluate the efficacy, safety and clinical dose exploration of Qishen Yiqi dripping pills in the treatment of chronic heart failure with preserved ejection fraction.

Conditions

Chronic Heart Failure With Preserved Ejection Fraction

Outcome Measures

Primary Outcomes (1)

• 6-Minutes-Walking-Test (6MWT)

  Change from baseline to weeks 12 and 24 in exercise capacity as measured by the 6-Minutes-Walking-Test (6MWT) distance.

  Baseline to weeks 12 and 24

Secondary Outcomes (5)

• NT-proBNP

  Baseline to weeks 2,4,8,12,16,20 and 24

• LAVI, E/ E ', E 'mean value, LVEF and tricuspid regurgitation velocity

  Baseline to weeks 4,12 and 24

• Hospitalizations for heart failure (first or repeated) and deaths from cardiovascular disease

  Week 24

• NYHA classification

  Baseline to weeks 2,4,8,12,16,20 and 24

• Minnesota Living With Heart Failure Questionnaire(MLHFQ) Score

  Baseline to weeks 12 and 24

Study Arms (3)

Low dose group

EXPERIMENTAL

The standard basic treatment is given according to the guidelines related to the underlying disease

Drug: Qishen Yiqi dripping pills 2 bags/time + Qishen Yiqi dripping pills placebo 2 bags/time

High dose group

EXPERIMENTAL

The standard basic treatment is given according to the guidelines related to the underlying disease

Drug: Qishen Yiqi dripping pills 4 bags/time

Placebo group

EXPERIMENTAL

The standard basic treatment is given according to the guidelines related to the underlying disease

Drug: Qishen Yiqi dripping pills placebo 4 bags/time

Interventions

Qishen Yiqi dripping pills 2 bags/time + Qishen Yiqi dripping pills placebo 2 bags/time DRUG

Take 3 times a day after meals,24 weeks

Low dose group

Qishen Yiqi dripping pills 4 bags/time DRUG

Take 3 times a day after meals,24 weeks

High dose group

Qishen Yiqi dripping pills placebo 4 bags/time DRUG

Take 3 times a day after meals,24 weeks

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects aged ≥ 18 years
• Diagnosed as chronic heart failure with preserved ejection fraction according to the Guidelines for Diagnosis and Treatment of Heart Failure in China 2018
• Have symptoms and/or signs of chronic heart failure at least 30 days before the trial
• LVEF≥50% according to echocardiography during screening stage
• BNP \> 35 ng/L and/or NT-proBNP \> 125 ng/L
• Cardiac structural changes or diastolic dysfunction according to echocardiography during screening stage, in line with at least one of the following:
• : LAVI\>34ml/m2
• : E/e'≥13
• : 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

You may not qualify if:

• People with any of the following cardiovascular diseases:
• 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
• Clinical evidence of acute coronary syndrome (including myocardial infarction, unstable angina pectoris) within 6 months before screening stage
• Received prior revascularization (such as PCI, CABG), or implantable cardioverter defibrillator (ICD), or other cardiac/cardiovascular procedures within 3 months before screening stage
• Received cardiac resynchronization therapy (CRT) within 6 months before screening stage
• 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
• 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
• Patients with pulmonary artery embolism caused by pulmonary hypertension, chronic obstructive pulmonary disease and other serious pulmonary diseases
• Hypertension that is difficult to control with medication (systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg)
• 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

Sponsors & Collaborators

• Tasly Pharmaceutical Group Co., Ltd: lead

Study Sites (16)

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

Location

Beijing Hospital

Beijing, Beijing Municipality, China

Location

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Location

Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality, China

Location

Peking University People's Hospital

Beijing, Bejing, China

Location

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Location

Hebei General Hospital

Shijiazhuang, Hebei, China

Location

The Third Affiliated Hospital of Xinxiang Medical College

Xinxiang, Henan, China

Location

The third Xiangya Hospital of Central South University

Changsha, Hunan, China

Location

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Location

Zhongda Hospital Southeast University

Nanjing, Jiangsu, China

Location

China Japan Union Hospital of Jilin University

Changchun, Jilin, China

Location

The Affiliated Hospital of Inner Mongolia Medical University

Hohhot, Nei Monggol Autonomous Region, China

Location

First Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Location

The Second Affiliated Hospital Of Xi'an Jiaotong University

Xi’an, Shanxi, China

Location

Tianjin Chest Hospital

Tianjin, Tianjin Municipality, China

Location

MeSH Terms

Interventions

Time

Intervention Hierarchy (Ancestors)

Physical Phenomena

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2021
• First Posted: June 30, 2021
• Study Start: July 27, 2021
• Primary Completion: December 19, 2024
• Study Completion: December 19, 2024
• Last Updated: January 9, 2025

Record last verified: 2024-08

Locations

CN (16)