Early ManagementPhase 4EMSAHFNCT03189901

Early Management Strategies of Acute Heart Failure for Patients With NSTEMI

A Phase 4 study testing Regular management+Levosimendan in people with Early Management and Acute Heart Failure, run by Qilu Hospital of Shandong University at 14 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 to 74 years
Conditions the study is for: Early Management, Acute Heart Failure, NSTEMI - Non-ST Segment Elevation MI
What is being tested?: Regular management+Levosimendan
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 470 participants
Where: 14 sitesChina
Study dates: 1 Jul 2017to 31 Dec 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 to 74 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients diagnosed with NSTEMI in outpatient service or admitted to hospital;
Patients with an elevated NT-proBNP level;
Patients sign the informed consent;

Who cannot join

Patients with hypotension(systolic pressure<100mmHg), creatinine clearance rate<30ml/min or be allergic to levosimendan;
Patients whose heart function grade of Killip are Level III~IV;
Patients suffering from hepatic failure, renal failure or other diseases which may shorten the lifetime to 6 months(for example tumor);
Patients with valvular heart diseases influencing haemodynamics, hypertrophic or restricted cardiomyopathy, constrictive pericarditis, severe pulmonary hypertension or myocarditis;
Patients with serum potassium level<3.5mmol/L;
Pregnant and lactating women;
Patients participating in other relevant clinical studies.

Trial locations and contacts

14 sites in 1 country.

City, postcode or hospital

14 sites in 1 country

China14 sites

Beijing China-Japan Friendship Hospital
Beijing, Beijng, 100000
Binzhou People's Hospital
Binzhou, Shandong, 256600
Shengli Oilfield Central Hospital
Dongying, Shandog, 257000
Anhui Provincial Hospital
Hefei, Anhui, 230000
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Jinan, Shandong, 250012
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Qilu Hospital of Shandong University (Qingdao)
Qingdao, 266000
Shengjing Hospital Affiliated to China Medical University
Shenyang, Liaoning, 110000
Tai'an Central Hospital
Tai’an, Shandong, 271000
Weifang People's Hospital
Weifang, Shandong, 261000
Weihai Municipal Hospital
Weihai, Shandong, 264200
Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221000
Yantaishan Hospital
Yantai, Shandong, 264000
Zibo Central Hospital
Zibo, Shandong, 255000

Other trials in China

About this study

There are always poor outcomes in patients with acute myocardial infarction(AMI) combined with elevated BNP/NT-proBNP level. An elevated BNP/NT-proBNP level highly indicates acute heart failure(AHF).Levosimendan is recommended in many clinical trials of heart failure and Chinese heart failure guidelines. As a result, the investigators form a hypothesis that when patients with AMI combined with elevated BNP/NT-proBNP level are in conditions before AHF, to use levosimendan may reduces the risk of heart failure and improve the outcome.

Conditions: Early Management, Acute Heart Failure, NSTEMI - Non-ST Segment Elevation MI
Being tested: Regular management+Levosimendan
Medical subject headings: Non-ST Elevated Myocardial Infarction

What participants receive

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

Regular management+LevosimendanDrug
Patients are treated with regular management recommended in guidelines and levosimendan.

Study groups in NCT03189901
Study group	Role	What they receive
Regular Management	No intervention	Patients with acute myocardial infarction(AMI) combined with elevated BNP/NT-proBNP level who treated by regular strategy in guideline.
Regular management+Levosimendan	Experimental	Patients with acute myocardial infarction(AMI) combined with elevated BNP/NT-proBNP level who treated by regular strategy in guideline and levosimendan. Receives: Drug: Regular management+Levosimendan

What is being measured

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

Blood NT-proBNP Level on 3 Days after Random Allocation
To test the blood NT-proBNP level in clinical labs 3 days after random allocation.
Measured: Venous blood is collected 3 days after random allocation. Blood NT-proBNP level is tested 1 month.
Rate of Change from Baseline Blood NT-proBNP Level on 5 Days after Random Allocation
To test the blood NT-proBNP level in clinical labs 5 days after random allocation, and compare it with blood NT-proBNP level tested at first medical contact(baseline).
Measured: Venous blood is collected at first medical contact and 5 days after random allocation, and blood NT-proBNP level is tested immediately after blood collection.

Secondary outcomes (6)

Acute Heart Failure Attack in Hospital
To record the number of times of acute heart failure attack in hospital, then analyse the statistic difference between two groups.
Measured: The data is collected during the in hospital period(an average of 2 weeks). Investigators analyse and summary the statistic difference between two groups through study completion.
Major Adverse Cardiovascular and Cerebrovascular Events in Hospital
Major Adverse Cardiovascular Events include all-cause mortality, cardiac death, non-fatal myocardial re-infarction, acute heart failure and stroke when patients are in hospital. Then the investigators analyse the statistic difference between two groups.
Measured: The data is collected during the in hospital period(an average of 2 weeks). Investigators analyse and summary the statistic difference between two groups through study completion.
Major Adverse Cardiovascular and Cerebrovascular Events on 6 Months
Major Adverse Cardiovascular Events include all-cause mortality, cardiac death, non-fatal myocardial re-infarction, rehospitalization because of acute heart failure and stroke on 6 months. Then the investigators analyse the statistic difference between two groups.
Measured: The data is collected on 6 months after patients discharged. Investigators analyse and summary the statistic difference between two groups through study completion.
Security evaluation of levosimendan
Serious adverse reaction such as shock, malignant arrhythmia and so on.
Measured: The data is collected during the time when levosimendan is used(an average of 24 hours). Investigators analyse and summary the statistic difference between two groups through study completion.
Health Economics Analysis
To do health economics analysis using the data including inpatient days, hospitalization costs.
Measured: The data is collected during the in hospital period(an average of 2 weeks). Investigators analyse and summary the statistic difference between two groups through study completion.
Rate of Patients Whose Plasma NT-proBNP Level Changes at least 30% on 5 Days after Random Allocation
To test the blood NT-proBNP level in clinical labs 5 days after random allocation, then calculate the rate of patients whose plasma NT-proBNP level decreased at least 30%(compared with blood NT-proBNP level tested at first medical contact).
Measured: Venous blood is collected at first medical contact and 5 days after random allocation, and blood NT-proBNP level is tested immediately after blood collection.

Timeline

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

1 Jul 201731 Dec 2021

First posted16 Jun 2017
Study start1 Jul 2017
Primary completion31 Dec 2021 (estimated)
Study completion31 Dec 2021 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Early ManagementStudies 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: None (open label)
Enrolment: 470 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03189901
Sponsor's protocol ID: QLemer2017030
Acronym: EMSAHF
Status last verified: Jul 2021
First submitted: 9 Jun 2017
Last updated: 19 Jul 2021
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 19 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Early Management Strategies of Acute Heart Failure for Patients With NSTEMI
ClinicalTrials.gov ID: NCT03189901
Acronym / sponsor ID: EMSAHF / QLemer2017030
Conditions: Early Management, Acute Heart Failure, NSTEMI - Non-ST Segment Elevation MI
Phase: Phase 4
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 470 participants (estimated)
Lead sponsor: Qilu Hospital of Shandong UniversityUniversity, hospital or other
Study start: 1 Jul 2017 (actual)
Primary completion: 31 Dec 2021 (estimated)
Study completion: 31 Dec 2021 (estimated)
First posted: 16 Jun 2017 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Regular Management	No intervention	–Patients with acute myocardial infarction(AMI) combined with elevated BNP/NT-proBNP level who treated by regular strategy in guideline.
Regular management+Levosimendan	Experimental	Drug: Regular management+LevosimendanPatients with acute myocardial infarction(AMI) combined with elevated BNP/NT-proBNP level who treated by regular strategy in guideline and levosimendan.

Who may qualify

Ages: 18 to 74 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patients diagnosed with NSTEMI in outpatient service or admitted to hospital;
Patients with an elevated NT-proBNP level;
Patients sign the informed consent;

Key exclusion criteria (7 listed)

Patients with hypotension(systolic pressure<100mmHg), creatinine clearance rate<30ml/min or be allergic to levosimendan;
Patients whose heart function grade of Killip are Level III~IV;
Patients suffering from hepatic failure, renal failure or other diseases which may shorten the lifetime to 6 months(for example tumor);
Patients with valvular heart diseases influencing haemodynamics, hypertrophic or restricted cardiomyopathy, constrictive pericarditis, severe pulmonary hypertension or myocarditis;
Patients with serum potassium level<3.5mmol/L;

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
Regular management+LevosimendanPatients are treated with regular management recommended in guidelines and levosimendan.	Drug	Regular management+Levosimendan

Primary outcome

Blood NT-proBNP Level on 3 Days after Random Allocation
Time frame: Venous blood is collected 3 days after random allocation. Blood NT-proBNP level is tested 1 month.
To test the blood NT-proBNP level in clinical labs 3 days after random allocation.
Rate of Change from Baseline Blood NT-proBNP Level on 5 Days after Random Allocation
Time frame: Venous blood is collected at first medical contact and 5 days after random allocation, and blood NT-proBNP level is tested immediately after blood collection.
To test the blood NT-proBNP level in clinical labs 5 days after random allocation, and compare it with blood NT-proBNP level tested at first medical contact(baseline).

6 secondary outcomes

Acute Heart Failure Attack in Hospital
Time frame: The data is collected during the in hospital period(an average of 2 weeks). Investigators analyse and summary the statistic difference between two groups through study completion.
Major Adverse Cardiovascular and Cerebrovascular Events in Hospital
Time frame: The data is collected during the in hospital period(an average of 2 weeks). Investigators analyse and summary the statistic difference between two groups through study completion.
Major Adverse Cardiovascular and Cerebrovascular Events on 6 Months
Time frame: The data is collected on 6 months after patients discharged. Investigators analyse and summary the statistic difference between two groups through study completion.
Security evaluation of levosimendan
Time frame: The data is collected during the time when levosimendan is used(an average of 24 hours). Investigators analyse and summary the statistic difference between two groups through study completion.
Health Economics Analysis
Time frame: The data is collected during the in hospital period(an average of 2 weeks). Investigators analyse and summary the statistic difference between two groups through study completion.
Rate of Patients Whose Plasma NT-proBNP Level Changes at least 30% on 5 Days after Random Allocation
Time frame: Venous blood is collected at first medical contact and 5 days after random allocation, and blood NT-proBNP level is tested immediately after blood collection.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2021.

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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.

The record lists no contact. Use the official record to reach the sponsor.

14 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 Regular management+Levosimendan in people with Early Management and Acute Heart Failure, run by Qilu Hospital of Shandong University at 14 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 3 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 19 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 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 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?

Blood NT-proBNP Level on 3 Days after Random Allocation (time frame: Venous blood is collected 3 days after random allocation. Blood NT-proBNP level is tested 1 month.). The study lists 2 primary outcomes in all. 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 NCT03189901.

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 19 Jul 2021.