Heart FailurePhase 4NCT04028544
The Study of Qishenyiqi Drop Pills in Improving the Prognosis of Heart Failure Patients
A Phase 4 study testing Qishenyiqi dropping pills in people with Heart Failure, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
Trial summary
This is a multicenter, randomized, double-blind, placebo-controlled study including patients with ejection fraction decreased heart failure under standardized treatment, to evaluate QiShenYiQi (QSYQ) dropping pill's curative effect in reducing cardiovascular death and heart failure rehospitalization compared with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Qishenyiqi dropping pills
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5,380 participants
- Where
- 1 siteChina
- Study dates
- 26 Mar 2019to Sep 2021
- Phase
- Phase 4
- 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
- Ability to understand the requirements of the study and willingness to provide written informed consent.
- Male or female subjects aged ≥ 18 years
- Patients with ejection fraction decreased heart failure (NYHA II-IV, Echocardiography with Simpson method within four weeks and NT-proBNP within two weeks before random) （1）35%≤LVEF≤40% ; NT-proBNP≥900pg/ml, patients with renal dysfunction (glomerular filtration rate <60 ml/min/1.73m2）or atrial fibrillation, the NT-proBNP should be ≥1200 pg/ml； （2）LVEF<35% (Simpson method); NT-proBNP≥600pg/ml, patients with renal dysfunction (glomerular filtration rate <60 ml/min/1.73m2）or atrial fibrillation, the NT-proBNP should be ≥900 pg/ml.
- A history of hospitalization or emergency treatment for heart failure in the past two years and a diagnosis of heart failure at least one month ago
- The use of medications in line with the recommendation of China heart failure treatment guidelines for at least 4 weeks. (Please confirm that all the following conditions must be met) : Including a ACEI or ARB, and a beta- blocker, unless contraindicated or not tolerated. The doses should reach the target dose recommended by the guideline or the maximum dose that the patient can tolerate, and the doses should not be changed within one months prior to screening and randomization (patients not take such drugs according to the guidelines, should be recorded).
Who cannot join
- Acute decompensated HF with hemodynamic instability, mechanical hemodynamic support or invasive mechanical ventilation within 14 days of randomization, using intravenous positive inotropic drugs, vasoactive drugs and intravenous diuretics within 7 days before randomization.
- Poorly controlled hypertension, defined as resting systolic blood pressure≥180mmHg and /or diastolic blood pressure ≥110mmHg assessed on two separate occasions prior to randomization.
- Liver transaminase (ALT or AST), bilirubin more than 3 times the upper limit of normal not caused by heart failure, glomerular filtration rate<15ml/min/1.73m2.
- Hemoglobin concentration ≤ 9.0g/dl and/or have blood system disease.
- Valvular heart disease, congenital heart disease without surgery.
- Cardiac shock.
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- Hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy, other secondary and invasive cardiomyopathy.
- Active myocarditis.
- Constrictive pericarditis, other pericardial diseases.
- Syncope within 3 months.
- Symptomatic bradycardia or II or III degrees heart block without a pacemaker.
- Ventricular arrhythmias affecting hemodynamics.
- Cardiac resynchronization therapy implanted pacemaker (CRT-P) or cardiac resynchronization therapy defibrillators (CRT-D) within 6 months, or upgrade the existing conventional pacemaker or implantable implantable defibrillator (ICD) to the CRT device, or have the intention to implant similar devices.
- Occurred within 3 months: acute coronary syndrome, stroke, transient ischemic attack; Heart, carotid artery or other large vascular surgery; Percutaneous coronary intervention (PCI) or carotid artery angioplasty, CABG or other cardiac surgery.
- Major surgery within 6 months prior to randomization.
- Has a history of heart transplantation or are waiting for transplants or using left ventricular assist device (LVAD) or have intention to heart transplant (waiting for transplants) or implant the VAD.
- Severe chronic obstructive pulmonary disease, pulmonary heart disease, sever pulmonary vascular disease, pulmonary hypertension caused by autoimmune disease, any type of severe pulmonary hypertension.
- History of major organ transplant (such as lung, liver, heart, bone marrow, kidney).
- Patients with serious primary diseases of liver, kidney, hematopoietic system, nervous system, endocrine system, and patients with cancer or mental illness.
- Life expectancy is less than 1 year.
- Known allergy to any study drug.
- Participants in other clinical studies within 1 month.
- Patients who are taking Chinese medicine and proprietary Chinese medicine with similar ingredients of QSYQ.
- Women who have developed pregnancy (pregnancy test positive) or during lactation; women of childbearing age have not taken adequate contraceptive measures.
- According to the researchers, patients could not complete the study or fail to comply with the requirements of the study (due to management or other reasons).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study of Qishenyiqi Drop Pills in Improving the Prognosis of Heart Failure Patients With Reduced Ejection Infarction
This is a multicenter, randomized, double-blind, placebo-controlled study including patients with ejection fraction decreased heart failure under standardized treatment, to evaluate QiShenYiQi (QSYQ) dropping pill's curative effect in reducing cardiovascular death and heart failure rehospitalization compared with placebo.
Read the detailed description
This is a prospective, large-scale samples, randomized, double-blind, placebo parallel-controlled, multicenter study to evaluate QSYQ's curative effect in reducing cardiovascular death and heart failure rehospitalization in patients with ejection fraction decreased heart failure（LVEF≤40%）under standardized treatment. The results will provide clinical evidence for combined treatment of traditional Chinese medicine and western medicine in ejection fraction decreased heart failure.
There are two treatment groups in the study, which are the treatment group with standard treatment + QSYS (oral use, 1 bag each time, three times a day) , and the control group with standard treatment + placebo (oral use, 1 bag each time, three times a day) .
The subjects are patients with ejection fraction decreased (≤40%) heart failure (NYHA II-IV). The sample size is 5380. For the primary end event, type I error is bilateral 0.05, and POWER was 0.8. The CV death and the HF readmission rate in the trial control group is 15%, and 12.7% in the experimental group. The trial cycle is about 3 years. A total of 4373 subjects will be assigned to the experimental group and the control group at a proportion of 1:1. The primary endpoint was expected to be 1211 cases. Taking into account the annual rate of lost to follow-up is about 18%, the final sample cases is 5380. During the treatment period and extends to at most 2weeks after treatment, patients will get examination including interviews (direct inquiries about the occurrence of adverse events and the situation of taking drugs), physical examination, body weight and the ECG. Laboratory parameters to evaluate clinical safety, such as routine blood, serum creatinine and urea nitrogen, electrolyte (serum potassium, sodium and chloride) and liver enzymes will be taken regularly. Researchers need to record and evaluate any occurrence of adverse events (AE) or serious adverse event (SAE) and its relevance to study medicine.
The primary endpoint is to evaluate whether QSYQ can reduce cardiovascular death and heart failure rehospitalization in chronic heart failure patients with reduced ejection infarction (HFREF) compared with placebo.
- Conditions
- Heart Failure
- Being tested
- Qishenyiqi dropping pills, Placebo
- Keywords
- heart failure, traditional Chinese medicine, prognosis, Qishenyiqi
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qishenyiqi dropping pillsDrug
Also called QSYQ
on the basis of standard treatment, adding QSYQ dropping pills 1 bag each time, 3 times a day
PlaceboDrug
Also called Placebo for QSYQ
on the basis of standard treatment, adding placebo 1 bag each time, 3 times a day
| Study group | Role | What they receive |
|---|---|---|
| The Treatment Group | Experimental | standard treatment + Qishenyiqi dropping pills (QSYQ) (oral use, 1 bag each time, three times a day) Receives: Drug: Qishenyiqi dropping pills |
| The Control Group | Placebo comparator | standard treatment + placebo (oral use, 1 bag each time, three times a day). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to the occurrence of cardiovascular (CV) death or heart failure (HF) re-hospitalization.
Compared with placebo, whether QSYQ prolong the occurrence of CV death or HF re-hospitalization of patients with chronic heart failure with lower ejection fraction (HFrEF). The treatment arm with the delayed events happening will be deemed as having a successful response.
Measured: up to 30 months
Secondary outcomes (8)
Time to the occurrence of all-cause death.
Compared with placebo, whether QSYQ prolong the occurrence of all-cause death of patients with HFrEF. The treatment arm with the delayed events happening will be deemed as having a successful response.
Measured: up to 30 months
Time to the occurrence of all-cause death or HF re-hospitalization.
Compared with placebo, whether QSYQ prolong the occurrence of all-cause death or HF re-hospitalization of patients with HFrEF. The treatment arm with the delayed events happening will be deemed as having a successful response.
Measured: up to 30 months
Time to the occurrence of CV death.
Compared with placebo, whether QSYQ prolong the occurrence of CV death of patients with HFrEF. The treatment arm with the delayed events happening will be deemed as having a successful response.
Measured: up to 30 months
Time to the occurrence of total HF re-hospitalization.
Compared with placebo, whether QSYQ prolong the occurrence of total HF re-hospitalization of patients with HFrEF. The treatment arm with the delayed events happening will be deemed as having a successful response.
Measured: up to 30 months
Time to the occurrence of composite endpoint.
Compared with placebo, whether QSYQ prolong the occurrence of composite endpoint (CV death, hospitalization for deteriorating heart failure, hospitalization for nonfatal myocardial infarction, and hospitalization for nonfatal stroke) of patients with HFrEF. The treatment arm with the delayed events happening will be deemed as having a successful response.
Measured: up to 30 months
Time to the first occurrence of HF hospitalization.
Compared with placebo, whether QSYQ prolong the first occurrence of HF hospitalization of patients with HFrEF. The treatment arm with the delayed events happening will be deemed as having a successful response.
Measured: up to 30 months
Change from baseline to week 48 for the Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score.
Compared with placebo, whether QSYQ improve the KCCQ score of patients with HFrEF at the 48th week. KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. KCCQ clinical summary score is a composite assessment of physical limitations and total symptom scores. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Measured: from baseline to week 48
Change from baseline to week 48 for the 6 minutes walking distance.
Compared with placebo, whether QSYQ improve the 6 minutes walking distance of patients with HFrEF at the 48th week.
Measured: from baseline to week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2019
- Study start26 Mar 2019
- Primary completionSep 2020 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Chinese Academy of Medical Sciences, Fuwai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 5,380 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Tianjin Tasly Pharmaceutical Co., Ltd
- Responsible party
- Principal investigator, Jian Zhang, Chinese Academy of Medical Sciences, Fuwai Hospital
- Investigators
- Jian Zhang, MD, Study chair, Heart Failure Center, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04028544
- Sponsor's protocol ID
- 2015-ZX55
- Status last verified
- Jun 2019
- First submitted
- 13 Jun 2019
- Last updated
- 22 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Study of Qishenyiqi Drop Pills in Improving the Prognosis of Heart Failure Patients With Reduced Ejection Infarction
- ClinicalTrials.gov ID
- NCT04028544
- Acronym / sponsor ID
- 2015-ZX55
- Conditions
- Heart Failure
- Keywords
- heart failure, traditional Chinese medicine, prognosis, Qishenyiqi
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5,380 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Collaborators
- Tianjin Tasly Pharmaceutical Co., Ltd
- Study start
- 26 Mar 2019 (actual)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 22 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, randomized, double-blind, placebo-controlled study including patients with ejection fraction decreased heart failure under standardized treatment, to evaluate QiShenYiQi (QSYQ) dropping pill's curative effect in reducing cardiovascular death and heart failure rehospitalization compared with placebo.
Detailed description
This is a prospective, large-scale samples, randomized, double-blind, placebo parallel-controlled, multicenter study to evaluate QSYQ's curative effect in reducing cardiovascular death and heart failure rehospitalization in patients with ejection fraction decreased heart failure（LVEF≤40%）under standardized treatment. The results will provide clinical evidence for combined treatment of traditional Chinese medicine and western medicine in ejection fraction decreased heart failure.
There are two treatment groups in the study, which are the treatment group with standard treatment + QSYS (oral use, 1 bag each time, three times a day) , and the control group with standard treatment + placebo (oral use, 1 bag each time, three times a day) .
The subjects are patients with ejection fraction decreased (≤40%) heart failure (NYHA II-IV). The sample size is 5380. For the primary end event, type I error is bilateral 0.05, and POWER was 0.8. The CV death and the HF readmission rate in the trial control group is 15%, and 12.7% in the experimental group. The trial cycle is about 3 years. A total of 4373 subjects will be assigned to the experimental group and the control group at a proportion of 1:1. The primary endpoint was expected to be 1211 cases. Taking into account the annual rate of lost to follow-up is about 18%, the final sample cases is 5380. During the treatment period and extends to at most 2weeks after treatment, patients will get examination including interviews (direct inquiries about the occurrence of adverse events and the situation of taking drugs), physical examination, body weight and the ECG. Laboratory parameters to evaluate clinical safety, such as routine blood, serum creatinine and urea nitrogen, electrolyte (serum potassium, sodium and chloride) and liver enzymes will be taken regularly. Researchers need to record and evaluate any occurrence of adverse events (AE) or serious adverse event (SAE) and its relevance to study medicine.
The primary endpoint is to evaluate whether QSYQ can reduce cardiovascular death and heart failure rehospitalization in chronic heart failure patients with reduced ejection infarction (HFREF) compared with placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The Treatment Group | Experimental | Drug: Qishenyiqi dropping pillsstandard treatment + Qishenyiqi dropping pills (QSYQ) (oral use, 1 bag each time, three times a day) |
| The Control Group | Placebo comparator | Drug: Placebostandard treatment + placebo (oral use, 1 bag each time, three times a day). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ability to understand the requirements of the study and willingness to provide written informed consent.
- Male or female subjects aged ≥ 18 years
- Patients with ejection fraction decreased heart failure (NYHA II-IV, Echocardiography with Simpson method within four weeks and NT-proBNP within two weeks before random) （1）35%≤LVEF≤40% ; NT-proBNP≥900pg/ml, patients with renal dysfunction (glomerular filtration rate <60 ml/min/1.73m2）or atrial fibrillation, the NT-proBNP should be ≥1200 pg/ml； （2）LVEF<35% (Simpson method); NT-proBNP≥600pg/ml, patients with renal dysfunction (glomerular filtration rate <60 ml/min/1.73m2）or atrial fibrillation, the NT-proBNP should be ≥900 pg/ml.
- A history of hospitalization or emergency treatment for heart failure in the past two years and a diagnosis of heart failure at least one month ago
- The use of medications in line with the recommendation of China heart failure treatment guidelines for at least 4 weeks. (Please confirm that all the following conditions must be met) : Including a ACEI or ARB, and a beta- blocker, unless contraindicated or not tolerated. The doses should reach the target dose recommended by the guideline or the maximum dose that the patient can tolerate, and the doses should not be changed within one months prior to screening and randomization (patients not take such drugs according to the guidelines, should be recorded).
Key exclusion criteria (25 listed)
- Acute decompensated HF with hemodynamic instability, mechanical hemodynamic support or invasive mechanical ventilation within 14 days of randomization, using intravenous positive inotropic drugs, vasoactive drugs and intravenous diuretics within 7 days before randomization.
- Poorly controlled hypertension, defined as resting systolic blood pressure≥180mmHg and /or diastolic blood pressure ≥110mmHg assessed on two separate occasions prior to randomization.
- Liver transaminase (ALT or AST), bilirubin more than 3 times the upper limit of normal not caused by heart failure, glomerular filtration rate<15ml/min/1.73m2.
- Hemoglobin concentration ≤ 9.0g/dl and/or have blood system disease.
- Valvular heart disease, congenital heart disease without surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Qishenyiqi dropping pillsAlso: QSYQon the basis of standard treatment, adding QSYQ dropping pills 1 bag each time, 3 times a day | Drug | The Treatment Group |
| PlaceboAlso: Placebo for QSYQon the basis of standard treatment, adding placebo 1 bag each time, 3 times a day | Drug | The Control Group |
Primary outcome
Time to the occurrence of cardiovascular (CV) death or heart failure (HF) re-hospitalization.
Time frame: up to 30 months
Compared with placebo, whether QSYQ prolong the occurrence of CV death or HF re-hospitalization of patients with chronic heart failure with lower ejection fraction (HFrEF). The treatment arm with the delayed events happening will be deemed as having a successful response.
8 secondary outcomes
Time to the occurrence of all-cause death.
Time frame: up to 30 months
Time to the occurrence of all-cause death or HF re-hospitalization.
Time frame: up to 30 months
Time to the occurrence of CV death.
Time frame: up to 30 months
Time to the occurrence of total HF re-hospitalization.
Time frame: up to 30 months
Time to the occurrence of composite endpoint.
Time frame: up to 30 months
Time to the first occurrence of HF hospitalization.
Time frame: up to 30 months
Change from baseline to week 48 for the Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score.
Time frame: from baseline to week 48
Change from baseline to week 48 for the 6 minutes walking distance.
Time frame: from baseline to week 48
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jian Zhang, MD study chair
Heart Failure Center, Fuwai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Qishenyiqi dropping pills in people with Heart Failure, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site 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 5 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: status not confirmed, as of the sponsor's last update on 22 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Time to the occurrence of cardiovascular (CV) death or heart failure (HF) re-hospitalization. (time frame: up to 30 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jul 2019.