Chronic Stable Heart FailurePhase 4NCT06699407
Qishenyiqi for Ventricular Remodeling After Myocardial Infarction
A Phase 4 study testing Qishenyiqi dripping pills in people with Chronic Stable Heart Failure, run by Qilu Hospital of Shandong University at 3 sites in China.
Trial summary
The effects of Qishenyiqi dripping pill on cardiac remodeling in patients with chronic stable heart failure have not been reported. This project aims to clarify the efficacy and safety of Qishenyiqi in patients with chronic heart failure after myocardial infarction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Stable Heart Failure
- What is being tested?
- Qishenyiqi dripping pills
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 3 sitesChina
- Study dates
- 20 Nov 2024to 31 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- 1) The history of acute myocardial infarction exceeds 3 months;
- 2) Symptoms and signs of heart failure have been stable for more than one month;
- 3) 18 years old or more;
- 4) NYHA cardiac function classified as grade II~IV;
- 5) LVEF≤40%；
- 6) NT-proBNP≥450pg/ml；
- 7) All subjects or their guardians must sign the subject consent before entering the trial.
Who cannot join
- 1) Patients with the following diseases: nonischemic cardiomyopathy; valvular heart disease; congenital heart disease; obstruction of left ventricular outflow tract; severe decompensated heart failure; active myocarditis or pericardial disease; end-stage liver and kidney diseases; malignant tumor;
- 2) Planned to undergo cardiac surgery within 12 months;
- 3) Mechanical complications of myocardial infarction;
- 4) Pregnant or nursing, or having the intention to give birth within one year;
- 5) Patients who participated in clinical research of other drugs within 3 months before being selected;
- 6) Patients with poor sound transmission windows are examined by transthoracic ultrasound.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites
Panpan Hao
Jinan, Shandong, 250012
Panpan Hao, 18560086593, panda.how@sdu.edu.cn
Qianfoshan Hospital, Shandong University
Jinan, Shandong, 250012
Jinan Central Hospital Affiliated to Shandong First Medical University
Jinan
About this study
Official title: Efficacy and Safety of Qishenyiqi Dripping Pills in Patients With Ventricular Remodeling and Chronic Heart Failure With Reduced Ejection Fraction After Myocardial Infarction
The effects of Qishenyiqi dripping pill on cardiac remodeling in patients with chronic stable heart failure have not been reported. This project aims to clarify the efficacy and safety of Qishenyiqi in patients with chronic heart failure after myocardial infarction. Patients with chronic stable heart failure after myocardial infarction were selected and randomly divided into two groups: the treatment group was treated with Qishenyiqi dripping pills; The control group was given placebo treatment. After 12 months of follow-up, the effects of Qishenyiqi on cardiac remodeling and function and cardiovascular adverse events were evaluated. The results are helpful to provide a new treatment strategy for chronic heart failure.
- Conditions
- Chronic Stable Heart Failure
- Being tested
- Qishenyiqi dripping pills, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qishenyiqi dripping pillsDrug
Qishenyiqi dripping pills, 1 bag once, three times a day, 12 months
PlaceboDrug
Placebo, 1 bag once, three times a day, 12 months
| Study group | Role | What they receive |
|---|---|---|
| Qishenyiqi | Experimental | Not described Receives: Drug: Qishenyiqi dripping pills |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
LVEDVI=LVEDV/BSA
Changes of left ventricular end-diastolic volume index (LVEDVI) compared with baseline after 12 months
Measured: From baseline to 12 months after follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start20 Nov 2024 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Stable Heart FailureStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe 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
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pan-Pan Hao, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06699407
- Sponsor's protocol ID
- Qishenyiqi and HFrEF
- Status last verified
- Nov 2024
- First submitted
- 18 Nov 2024
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Qishenyiqi Dripping Pills in Patients With Ventricular Remodeling and Chronic Heart Failure With Reduced Ejection Fraction After Myocardial Infarction
- ClinicalTrials.gov ID
- NCT06699407
- Acronym / sponsor ID
- Qishenyiqi and HFrEF
- Conditions
- Chronic Stable Heart Failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 20 Nov 2024 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 21 Nov 2024 (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.
The effects of Qishenyiqi dripping pill on cardiac remodeling in patients with chronic stable heart failure have not been reported. This project aims to clarify the efficacy and safety of Qishenyiqi in patients with chronic heart failure after myocardial infarction. Patients with chronic stable heart failure after myocardial infarction were selected and randomly divided into two groups: the treatment group was treated with Qishenyiqi dripping pills; The control group was given placebo treatment. After 12 months of follow-up, the effects of Qishenyiqi on cardiac remodeling and function and cardiovascular adverse events were evaluated. The results are helpful to provide a new treatment strategy for chronic heart failure.
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 |
|---|---|---|
| Qishenyiqi | Experimental | Drug: Qishenyiqi dripping pills |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 1) The history of acute myocardial infarction exceeds 3 months;
- 2) Symptoms and signs of heart failure have been stable for more than one month;
- 3) 18 years old or more;
- 4) NYHA cardiac function classified as grade II~IV;
- 5) LVEF≤40%；
Key exclusion criteria (6 listed)
- 1) Patients with the following diseases: nonischemic cardiomyopathy; valvular heart disease; congenital heart disease; obstruction of left ventricular outflow tract; severe decompensated heart failure; active myocarditis or pericardial disease; end-stage liver and kidney diseases; malignant tumor;
- 2) Planned to undergo cardiac surgery within 12 months;
- 3) Mechanical complications of myocardial infarction;
- 4) Pregnant or nursing, or having the intention to give birth within one year;
- 5) Patients who participated in clinical research of other drugs within 3 months before being selected;
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 dripping pillsQishenyiqi dripping pills, 1 bag once, three times a day, 12 months | Drug | Qishenyiqi |
| PlaceboPlacebo, 1 bag once, three times a day, 12 months | Drug | Placebo |
Primary outcome
LVEDVI=LVEDV/BSA
Time frame: From baseline to 12 months after follow-up
Changes of left ventricular end-diastolic volume index (LVEDVI) compared with baseline after 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Chronic Stable Heart Failure
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RecruitingPhase 2
Efficacy of LoDoCo in Improving Exercise Capacity Among Patients With HFpEF and Inflammation
Heart Failure, Inflammation
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Nurse-Led Education for Heart Failure Self-Care and Stability
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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.
3 sites 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 dripping pills in people with Chronic Stable Heart Failure, run by Qilu Hospital of Shandong University at 3 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 7 inclusion and 6 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: opening soon, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Panpan Hao (18560086593, panda.how@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LVEDVI=LVEDV/BSA (time frame: From baseline to 12 months after follow-up). 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 21 Nov 2024.