ST Elevation Myocardial InfarctionPhase 4NCT04970238
Effect of Levosimendan on Left Ventricular Systolic Function and Heart Failure After PCI in Patients With Acute Anterior Myocardial Infarction
A Phase 4 study testing Levosimendan in people with ST Elevation Myocardial Infarction and Heart Failure, run by Zhijun Sun at 1 site in China.
Trial summary
Reperfusion therapy for acute ST segment elevation myocardial infarction (STEMI) can significantly reduce mortality, but patients may still have heart failure and adverse cardiovascular events due to massive myocardial loss. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ST Elevation Myocardial Infarction, Heart Failure
- What is being tested?
- Levosimendan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- Oct 2021to Jan 2023
- 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
- 1. Age ≥ 18 years old.
- 2. Acute anterior wall myocardial infarction (ECG indicates acute anterior wall, acute anterior wall myocardial infarction, acute extensive anterior wall myocardial infarction).
- 3. The onset time of chest pain was less than 12 hours, and agreed to emergency PCI treatment.
- 4. Be able to understand and sign informed consent voluntarily.
Who cannot join
- 1. Patients who cannot undergo PCI treatment after coronary angiography, or those who fail to open blood vessels, or refuse to undergo PCI treatment.
- 2. Those whose coronary angiography results indicated myocardial infarction caused by non-coronary artery disease or residual stenosis < 50% after reanalization of myocardial infarction without PCI treatment.
- 3. Patients with old anterior wall myocardial infarction.
- 4. Previous history of cardiac insufficiency.
- 5. Both anterior descending stent implantation, stent restenosis or stent thrombosis.
- 6. Symptomatic hypotension, systolic blood pressure < 90mmHg (still < 90mmHg with IABP)
Show all 10Show fewer
- 7, body temperature > 38.5℃, or with serious infectious diseases (severe myocarditis, severe pneumonia, severe urinary tract infection, etc.).
- 8. Severe other organ diseases (renal insufficiency: EGFR < 30ml/min, severe liver insufficiency, moderate and severe anemia, malignant tumor, hematologic system diseases, etc.).
- 9. Known or suspected allergy to the active or inactive ingredients of the drug under study.
- 10. Participated in other drug clinical trials within 3 months before the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Levosimendan on Left Ventricular Systolic Function and Heart Failure After PCI in Patients With Acute Anterior Myocardial Infarction-- Multicenter Prospective Randomized Controlled Trial
Reperfusion therapy for acute ST segment elevation myocardial infarction (STEMI) can significantly reduce mortality, but patients may still have heart failure and adverse cardiovascular events due to massive myocardial loss. About 20% of patients present with acute heart failure (AHF) at admission, It is the most important cause of hospital death in acute myocardial infarction. Because of the large necrotic area of acute anterior myocardial infarction, heart failure still occurs in a considerable number of patients even after revascularization (PCI). Myocardial protection of ischemic myocardium is a hot topic in clinical research.
Both ESC and Chinese heart failure guidelines recommend levosimendan for the treatment of acute decompensated heart failure. A large number of studies have proved that levosimendan can significantly reduce myocardial injury and improve cardiac function in patients with acute STEMI complicated with left ventricular dysfunction and cardiogenic shock compared with placebo. Basic research has confirmed that levosimendan can reduce the myocardial infarction area after acute coronary occlusion, improve the left ventricular function, and exert the effects of anti myocardial ischemia, myocardial injury, myocardial fibrosis, ventricular remodeling and anti apoptosis. However, there is still a lack of early preventive application of levosimendan in acute anterior myocardial infarction after PCI to improve ventricular remodeling and reduce the incidence of heart failure.
The purpose of this study was to investigate the effect of early prophylactic levosimendan on left ventricular remodeling, ischemic myocardial protection and the development of heart failure in patients with acute anterior myocardial infarction after PCI.
- Conditions
- ST Elevation Myocardial Infarction, Heart Failure
- Being tested
- Levosimendan, placebo
- Keywords
- Heart Failure, Levosimendan
- Medical subject headings
- ST Elevation Myocardial Infarction, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevosimendanDrug
Test drug: drug preparation method: 5ml (12.5mg) levosimendan injection was mixed with 500ml 5% glucose injection, the initial loading dose was 6 µg / kg for 10 minutes, followed by continuous infusion of 0.1 µg/ kg / min for 24 hours.
placeboOther
Control drug: 5% glucose injection, intravenous injection method is the same as the experimental group pump dose, the initial load dose of treatment is 6 µg / kg for 10 minutes, followed by continuous infusion of 0.1 µg / kg / min for 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| Levosimendan group | Experimental | Not described Receives: Drug: Levosimendan |
| placebo group | Placebo comparator | Not described Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of heart failure
6 month of heart failure
Measured: 6 month
Major Adverse Cardiovascular Events (MACE)
Mace is defined as cardiovascular death and cardiovascular related readmission
Measured: 6 months
Left ventricular systolic function
At 72 hours, left ventricular systolic function of AFI is as follows ( PSD, GLS, PSI)
Measured: 72 hours
Secondary outcomes (2)
NT-ProBNP
Changes of NT-ProBNP at 72 hours and 30 days
Measured: 30 days
Patient quality of life score
Seattle Angina Questionnaiire is used, The full score of five items in the scale is 100. The higher the score is, the better the condition is.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study startOct 2021 (estimated)
- Primary completionJan 2023 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhijun Sun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhijun Sun, Shengjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04970238
- Sponsor's protocol ID
- 2021PS522K
- Status last verified
- Aug 2021
- First submitted
- 16 Jun 2021
- Last updated
- 20 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Levosimendan on Left Ventricular Systolic Function and Heart Failure After PCI in Patients With Acute Anterior Myocardial Infarction-- Multicenter Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04970238
- Acronym / sponsor ID
- 2021PS522K
- Conditions
- ST Elevation Myocardial Infarction, Heart Failure
- Keywords
- Heart Failure, Levosimendan
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Zhijun SunUniversity, hospital or other
- Study start
- Oct 2021 (estimated)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 21 Jul 2021 (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.
Reperfusion therapy for acute ST segment elevation myocardial infarction (STEMI) can significantly reduce mortality, but patients may still have heart failure and adverse cardiovascular events due to massive myocardial loss. About 20% of patients present with acute heart failure (AHF) at admission, It is the most important cause of hospital death in acute myocardial infarction. Because of the large necrotic area of acute anterior myocardial infarction, heart failure still occurs in a considerable number of patients even after revascularization (PCI). Myocardial protection of ischemic myocardium is a hot topic in clinical research.
Both ESC and Chinese heart failure guidelines recommend levosimendan for the treatment of acute decompensated heart failure. A large number of studies have proved that levosimendan can significantly reduce myocardial injury and improve cardiac function in patients with acute STEMI complicated with left ventricular dysfunction and cardiogenic shock compared with placebo. Basic research has confirmed that levosimendan can reduce the myocardial infarction area after acute coronary occlusion, improve the left ventricular function, and exert the effects of anti myocardial ischemia, myocardial injury, myocardial fibrosis, ventricular remodeling and anti apoptosis. However, there is still a lack of early preventive application of levosimendan in acute anterior myocardial infarction after PCI to improve ventricular remodeling and reduce the incidence of heart failure.
The purpose of this study was to investigate the effect of early prophylactic levosimendan on left ventricular remodeling, ischemic myocardial protection and the development of heart failure in patients with acute anterior myocardial infarction after PCI.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levosimendan group | Experimental | Drug: Levosimendan |
| placebo group | Placebo comparator | Other: placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1. Age ≥ 18 years old.
- 2. Acute anterior wall myocardial infarction (ECG indicates acute anterior wall, acute anterior wall myocardial infarction, acute extensive anterior wall myocardial infarction).
- 3. The onset time of chest pain was less than 12 hours, and agreed to emergency PCI treatment.
- 4. Be able to understand and sign informed consent voluntarily.
Key exclusion criteria (10 listed)
- 1. Patients who cannot undergo PCI treatment after coronary angiography, or those who fail to open blood vessels, or refuse to undergo PCI treatment.
- 2. Those whose coronary angiography results indicated myocardial infarction caused by non-coronary artery disease or residual stenosis < 50% after reanalization of myocardial infarction without PCI treatment.
- 3. Patients with old anterior wall myocardial infarction.
- 4. Previous history of cardiac insufficiency.
- 5. Both anterior descending stent implantation, stent restenosis or stent thrombosis.
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 |
|---|---|---|
| LevosimendanTest drug: drug preparation method: 5ml (12.5mg) levosimendan injection was mixed with 500ml 5% glucose injection, the initial loading dose was 6 µg / kg for 10 minutes, followed by continuous infusion of 0.1 µg/ kg / min for 24 hours. | Drug | Levosimendan group |
| placeboControl drug: 5% glucose injection, intravenous injection method is the same as the experimental group pump dose, the initial load dose of treatment is 6 µg / kg for 10 minutes, followed by continuous infusion of 0.1 µg / kg / min for 24 hours. | Other | placebo group |
Primary outcome
Occurrence of heart failure
Time frame: 6 month
6 month of heart failure
Major Adverse Cardiovascular Events (MACE)
Time frame: 6 months
Mace is defined as cardiovascular death and cardiovascular related readmission
Left ventricular systolic function
Time frame: 72 hours
At 72 hours, left ventricular systolic function of AFI is as follows ( PSD, GLS, PSI)
2 secondary outcomes
NT-ProBNP
Time frame: 30 days
Patient quality of life score
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2021.
Related trials for ST Elevation Myocardial Infarction
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
RecruitingPhase 2
Prevention of Reperfusion Injury Outcomes Through Effective Cardioprotection Targeting Myocardial Infarction
Myocardial Infarction, Reperfusion Injury
Not yet recruitingObservational study
Incremental Prognostic Utility of CBC-derived Inflammatory Indices After Incomplete Coronary Revascularization: Association With 12-months Cardiovascular Outcomes
STEMI, High Risk NSTEMI
RecruitingObservational study
SuperSaturated Oxygen Comprehensive Observational Registry
STEMI - ST Elevation Myocardial Infarction, AMI
RecruitingPhase 4
Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction
ST Elevation Myocardial Infarction
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Levosimendan in people with ST Elevation Myocardial Infarction and Heart Failure, run by Zhijun Sun 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 4 inclusion and 10 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 20 Aug 2021. 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?
Occurrence of heart failure (time frame: 6 month). The study lists 3 primary outcomes in all. 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 20 Aug 2021.