Early Management Strategies of Acute Heart Failure for Patients With NSTEMI (EMSAHF)

Shandong University

Status and phase: Unknown; Phase 4

Conditions: Early Management; NSTEMI - Non-ST Segment Elevation MI; Acute Heart Failure

Treatments: Drug: Regular management+Levosimendan

Study type: Interventional

Funder types: Other

Identifiers

NCT03189901

QLemer2017030

Details and patient eligibility

About

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.

Enrollment: 470 estimated patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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470 participants in 2 patient groups

Regular Management

No Intervention group

Description:

Patients with acute myocardial infarction(AMI) combined with elevated BNP/NT-proBNP level who treated by regular strategy in guideline.

Regular management+Levosimendan

Experimental group

Description:

Patients with acute myocardial infarction(AMI) combined with elevated BNP/NT-proBNP level who treated by regular strategy in guideline and levosimendan.

Treatment:

Drug: Regular management+Levosimendan