Heart ArrestPhase 4NCT05956431
RCT Study of Levosimendan Improving Prognosis of Cardiac Arrest
A Phase 4 study testing Levosimendan Injection and physiological saline in people with Heart Arrest, run by Peking University Third Hospital.
Trial summary
This study is intended to use a multicenter, double-blind, superior effect, placebo controlled randomized controlled clinical trial to explore the therapeutic effect of Levosimendan (within 6 hours after the recovery of spontaneous circulation) on mortality and multiple organ dysfunction such as heart and brain in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Arrest
- What is being tested?
- Levosimendan Injection and physiological saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2023to 31 Dec 2024
- 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: After active Cardiopulmonary resuscitation, patients with cardiac arrest obtain the recovery of spontaneous circulation (ROSC), which is defined as having palpable arterial pulse lasting for more than 20 minutes
- 3: Patients with witnessed cardiac arrest
- 4: ROSC lasts for less than 60 minutes
- 5: Low cardiac output syndrome after ROSC (LVEF<40%)
- 6: Still in a coma after ROSC, Glasgow score<8 points
- 7: Complete enrollment within 180 minutes after ROSC
Who cannot join
- 1: Patients receiving extracorporeal Cardiopulmonary resuscitation
- 2: Patients with severe neurological deficits prior to cardiac arrest
- 3: Patients with severe renal dysfunction (creatinine clearance rate<30ml/min)
- 4: Patients with confirmed or suspected pregnancy
- 5: Patients with Intracranial hemorrhage
- 6: Patients with end-stage diseases, such as advanced malignant tumors or other severe wasting diseases
- 7: Patients who are unwilling to participate in the study
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized Controlled Clinical Study of Early Application of Levosimendan to Improve Cardiac Dysfunction and Neurological Prognosis in Patients With Cardiac Arrest
This study is intended to use a multicenter, double-blind, superior effect, placebo controlled randomized controlled clinical trial to explore the therapeutic effect of Levosimendan (within 6 hours after the recovery of spontaneous circulation) on mortality and multiple organ dysfunction such as heart and brain in patients with cardiac arrest who have recovered from active Cardiopulmonary resuscitation but have low cardiac output syndrome and coma, and the impact of 30-day mortality and neurological function after cardiac arrest.
- Conditions
- Heart Arrest
- Being tested
- Levosimendan Injection, physiological saline
- Keywords
- cardiac arrest, Levosimendan Injection, prognosis
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levosimendan InjectionDrug
Also called Intervention Group
The administration scheme of Levosimendan is continuous intravenous infusion at the rate of 0.05-0.2 μg/kg/min for 24 hours, and no load is given to reduce the risk of Hypotension.
physiological salineDrug
Also called Placebo Group
The placebo group received continuous intravenous infusion of physiological saline at the rate of 0.05-0.2 μg/kg/min for 24 hours, while also receiving comprehensive cluster therapy with PCAS.
| Study group | Role | What they receive |
|---|---|---|
| Levosimendan group | Experimental | The administration scheme of Levosimendan is continuous intravenous infusion at the rate of 0.05-0.2 μg/kg/min for 24 hours, and no load is given to reduce the risk of Hypotension. Receives: Drug: Levosimendan Injection |
| Placebo group | Placebo comparator | The placebo group received continuous intravenous infusion of physiological saline at the rate of 0.05-0.2 μg/kg/min for 24 hours, while also receiving comprehensive cluster therapy with PCAS. Receives: Drug: physiological saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral Performance Category (CPC)
The mortality rate and neurological prognosis at 30 days after cardiac arrest. The evaluation of neurological function adopts CPC score, with CPC 1-2 grading indicating a good prognosis for neurological function and CPC 3-5 grading indicating a poor prognosis for neurological function.
Measured: On the 30th day after cardiac arrest
Secondary outcomes (5)
Survival rate
Survival rate after 1 week of resuscitation was counted
Measured: after 1 week of resuscitation
Echocardiography
After enrollment, echocardiography parameters were collected according to the time nodes specified in this research process
Measured: On the first week after resuscitation
Neuron-Specific Enolase (NSE)
After enrollment, NSE was collected according to the specified time points in this study process
Measured: On the first week after resuscitation
Gray-to-White Matter Ratio (GWR)
After enrollment, head CT GWR were collected according to the specified time points in this study process
Measured: On the first week after resuscitation
Serum creatinine
After enrollment, serum creatinine indicators representing renal function were collected according to the specified time
Measured: On the first week after resuscitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study start1 Aug 2023 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart ArrestStudies of the same condition, open and under way.
- More trials run by Peking University Third 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Qilu Hospital of Shandong University
- Responsible party
- Principal investigator, Du Lanfang, Peking University Third Hospital
- Investigators
- Ma Qingbian, doctor, Study chair, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05956431
- Sponsor's protocol ID
- M2023327
- Status last verified
- Jul 2023
- First submitted
- 4 Jul 2023
- Last updated
- 21 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The research results will be shared.
Publications
De Z, Xu N, Zhang H, Yang F, Du L. Early use of levosimendan to improve survival and neurological outcomes after cardiac arrest with myocardial dysfunction: a protocol for a randomized controlled trial. Front Cardiovasc Med. 2026 Sep 17;13:1850394. doi: 10.3389/fcvm.2026.1850394. eCollection 2026.
PubMed 42824027
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Clinical Study of Early Application of Levosimendan to Improve Cardiac Dysfunction and Neurological Prognosis in Patients With Cardiac Arrest
- ClinicalTrials.gov ID
- NCT05956431
- Acronym / sponsor ID
- M2023327
- Conditions
- Heart Arrest
- Keywords
- cardiac arrest, Levosimendan Injection, prognosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- Qilu Hospital of Shandong University
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 21 Jul 2023 (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 study is intended to use a multicenter, double-blind, superior effect, placebo controlled randomized controlled clinical trial to explore the therapeutic effect of Levosimendan (within 6 hours after the recovery of spontaneous circulation) on mortality and multiple organ dysfunction such as heart and brain in patients with cardiac arrest who have recovered from active Cardiopulmonary resuscitation but have low cardiac output syndrome and coma, and the impact of 30-day mortality and neurological function after cardiac arrest.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levosimendan group | Experimental | Drug: Levosimendan InjectionThe administration scheme of Levosimendan is continuous intravenous infusion at the rate of 0.05-0.2 μg/kg/min for 24 hours, and no load is given to reduce the risk of Hypotension. |
| Placebo group | Placebo comparator | Drug: physiological salineThe placebo group received continuous intravenous infusion of physiological saline at the rate of 0.05-0.2 μg/kg/min for 24 hours, while also receiving comprehensive cluster therapy with PCAS. |
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: Age>18 years old
- 2: After active Cardiopulmonary resuscitation, patients with cardiac arrest obtain the recovery of spontaneous circulation (ROSC), which is defined as having palpable arterial pulse lasting for more than 20 minutes
- 3: Patients with witnessed cardiac arrest
- 4: ROSC lasts for less than 60 minutes
- 5: Low cardiac output syndrome after ROSC (LVEF<40%)
Key exclusion criteria (7 listed)
- 1: Patients receiving extracorporeal Cardiopulmonary resuscitation
- 2: Patients with severe neurological deficits prior to cardiac arrest
- 3: Patients with severe renal dysfunction (creatinine clearance rate<30ml/min)
- 4: Patients with confirmed or suspected pregnancy
- 5: Patients with Intracranial hemorrhage
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 |
|---|---|---|
| Levosimendan InjectionAlso: Intervention GroupThe administration scheme of Levosimendan is continuous intravenous infusion at the rate of 0.05-0.2 μg/kg/min for 24 hours, and no load is given to reduce the risk of Hypotension. | Drug | Levosimendan group |
| physiological salineAlso: Placebo GroupThe placebo group received continuous intravenous infusion of physiological saline at the rate of 0.05-0.2 μg/kg/min for 24 hours, while also receiving comprehensive cluster therapy with PCAS. | Drug | Placebo group |
Primary outcome
Cerebral Performance Category (CPC)
Time frame: On the 30th day after cardiac arrest
The mortality rate and neurological prognosis at 30 days after cardiac arrest. The evaluation of neurological function adopts CPC score, with CPC 1-2 grading indicating a good prognosis for neurological function and CPC 3-5 grading indicating a poor prognosis for neurological function.
5 secondary outcomes
Survival rate
Time frame: after 1 week of resuscitation
Echocardiography
Time frame: On the first week after resuscitation
Neuron-Specific Enolase (NSE)
Time frame: On the first week after resuscitation
Gray-to-White Matter Ratio (GWR)
Time frame: On the first week after resuscitation
Serum creatinine
Time frame: On the first week after resuscitation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2023.
- Derived from this study: PubMed 42824027De Z, Xu N, Zhang H, Yang F, Du L. Early use of levosimendan to improve survival and neurological outcomes after cardiac arrest with myocardial dysfunction: a protocol for a randomized controlled trial. Front Cardiovasc Med. 2026 Sep 17;13:1850394. doi: 10.3389/fcvm.2026.1850394. eCollection 2026.
- Individual participant dataSharing planned: Yes. The research results will be shared.
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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.
Ma Qingbian, doctor study chair
Peking University Third Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Levosimendan Injection and physiological saline in people with Heart Arrest, run by Peking University Third Hospital.
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 7 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 21 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Du Lanfang, doctor (13810363269, angelslovedudu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral Performance Category (CPC) (time frame: On the 30th day after cardiac arrest). 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 NCT05956431, which also lists 1 linked publication.
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 Jul 2023.