AzTrials
AzTrials

Chronic Heart Failure With Preserved Ejection FractionPhase 2NCT04944706

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

A Phase 2 study testing Qishen Yiqi dripping pills 4 bags/time in people with Chronic Heart Failure With Preserved Ejection Fraction, run by Tasly Pharmaceutical Group Co., Ltd at 16 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Qishen Yiqi dripping pills 4 bags/time
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
225 participants
Where
16 sitesChina
Study dates
18 Oct 2021to 22 Jan 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 14Show fewer
  • : 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

Who cannot join

  • 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
Show all 25Show fewer
  • 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
  • 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

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

China16 sites

  • Beijing Hospital

    Beijing, Beijing Municipality

  • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality

  • Xuanwu Hospital Capital Medical University

    Beijing, Beijing Municipality

  • Peking University People's Hospital

    Beijing, Bejing

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui

  • China Japan Union Hospital of Jilin University

    Changchun, Jilin

  • The third Xiangya Hospital of Central South University

    Changsha, Hunan

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality

  • The Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Nei Monggol Autonomous Region

  • Jiangsu Province Hospital

    Nanjing, Jiangsu

  • Zhongda Hospital Southeast University

    Nanjing, Jiangsu

  • Hebei General Hospital

    Shijiazhuang, Hebei

  • First Hospital of Shanxi Medical University

    Taiyuan, Shanxi

  • Tianjin Chest Hospital

    Tianjin, Tianjin Municipality

  • The Second Affiliated Hospital Of Xi'an Jiaotong University

    Xi’an, Shanxi

  • The Third Affiliated Hospital of Xinxiang Medical College

    Xinxiang, Henan

Other trials in China

About this study

Official title: Efficacy and Safety of Qishenyiqi Dripping Pills for Treating Chronic Heart Failure With Preserved Ejection Fraction: a Randomized, Double-blind, Basic-treatment-loading, Placebo-controlled, Multicenter Phase Ⅱ Clinical Trial

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.

Read the detailed description

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.

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.

Being tested
Qishen Yiqi dripping pills 2 bags/time + Qishen Yiqi dripping pills placebo 2 bags/time, Qishen Yiqi dripping pills 4 bags/time, Qishen Yiqi dripping pills placebo 4 bags/time

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Qishen Yiqi dripping pills 2 bags/time + Qishen Yiqi dripping pills placebo 2 bags/timeDrug

    Take 3 times a day after meals,24 weeks

  • Qishen Yiqi dripping pills 4 bags/timeDrug

    Take 3 times a day after meals,24 weeks

  • Qishen Yiqi dripping pills placebo 4 bags/timeDrug

    Take 3 times a day after meals,24 weeks

Study groups in NCT04944706
Study groupRoleWhat they receive
Low dose groupExperimentalThe standard basic treatment is given according to the guidelines related to the underlying disease
Receives: Drug: Qishen Yiqi dripping pills 2 bags/time + Qishen Yiqi dripping pills placebo 2 bags/time
High dose groupExperimentalThe standard basic treatment is given according to the guidelines related to the underlying disease
Receives: Drug: Qishen Yiqi dripping pills 4 bags/time
Placebo groupExperimentalThe standard basic treatment is given according to the guidelines related to the underlying disease
Receives: Drug: Qishen Yiqi dripping pills placebo 4 bags/time

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline to weeks 12 and 24

Secondary outcomes (5)

  1. NT-proBNP

    Change from baseline to weeks 2,4,8,12,16,20 and 24 in NT-proBNP.

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

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

    Change from baseline to weeks 4,12 and 24 in left atrial volume index, mitral inflow velocity early diastolic blood flow velocity peak to mitral annular relaxation velocity ratio, mitral annular relaxation velocity mean value, left ventricular ejection fraction and tricuspid regurgitation velocity measured by echocardiography.

    Measured: Baseline to weeks 4,12 and 24

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

    Compound and separate rates of hospitalization for heart failure (first or repeated) and death from cardiovascular disease at week 24.

    Measured: Week 24

  4. NYHA classification

    Percentage of subjects whose NYHA classification improved/worsened/remained unchanged from baseline to weeks 2,4,8,12,16,20 and 24.

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

  5. Minnesota Living With Heart Failure Questionnaire(MLHFQ) Score

    Change from baseline to weeks 12 and 24 in Minnesota Living With Heart Failure Questionnaire(MLHFQ) Score.

    Measured: Baseline to weeks 12 and 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2021
  2. Study start18 Oct 2021
  3. Primary completion22 Jan 2025
  4. Study completion22 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
225 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04944706
Sponsor's protocol ID
TSL-TCM-QSYQDW-HFpEF-Ⅱ
Status last verified
Aug 2024
First submitted
15 Jun 2021
Last updated
23 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Qishen Yiqi dripping pills 4 bags/time in people with Chronic Heart Failure With Preserved Ejection Fraction, run by Tasly Pharmaceutical Group Co., Ltd at 16 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

6-Minutes-Walking-Test (6MWT) (time frame: Baseline to weeks 12 and 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04944706.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in