Acute and Chronic Protective Effects of Peri-interventional Administration of Levosimendan in ST Elevation Myocardial Infarctions

RWTH Aachen University

Status: Withdrawn

Conditions: Outcome; Myocardial Infarction

Treatments: Drug: Levosimendan

Study type: Interventional

Funder types: Other

Identifiers

NCT03022877

Levo-STEMI

Details and patient eligibility

About

In the proposed project the investigators want to assess whether the approach of the post-conditioning by Levosimendan in patients with acute STEMI is safe and reproducible, can be used with a positive influence on the outcomes with respect to myocardial damage, cardiac left ventricular remodeling, myocardial function, the occurrence of cardiac events and quality of life.

Full description

An acute ST-elevation myocardial infarction (STEMI) is a severe disease that triggers an adverse remodeling, and served in progressive heart failure with a case fatality rate of 50% in 5 years. The opening of the occluded vessel is the first and most important therapy, the reperfusion improved both the function as well as the long-term survival. At the same time, experimental and clinical studies show, however, that this reperfusion self-reinforced damage of the myocardium. An additional Intervention in this trigger phase could not only reduce the acute damage, but long-term protective effects. Both effects could be an approach for the Calcium-Sensitizer Levosimendan in the animal model. So far, no clear effect on the remodeling and survive was demonstrated after myocardial infarction in the clinic. This could be mainly due to the delayed application in relation to the reperfusion and on the selection of suitable methods for the presentation of the effects on myocardial structure and function. In the proposed project the investigators want to assess whether the approach of the post-conditioning by Levosimendan in patients with acute STEMI is safe and reproducible, can be used with a positive influence on the outcomes with respect to myocardial damage, cardiac left ventricular remodeling, myocardial function, the occurrence of cardiac events and quality of life.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• STEMI of the anterior wall < 6 hrs
• capacity to Consent

Exclusion criteria

• previous myocardial infarction or bypass surgery
• relevant vitium
• STEMI of the posterior wall
• any contraindications to MRI
• unstable hemodynamics (hypotension, catecholamine therapy, severe arrhythmia), -respiratory failure
• onset of symptoms more than 6 hours.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo is given as a Bolus (instead of Bolus application of Levosimendan) over 10 min i.v., starting 10 min before recanalization.

Treatment:

Drug: Levosimendan

Bolus Levosimendan

Active Comparator group

Description:

Levosimendan is given as Bolus (12 µg/kg over 10 min i.v.), starting 10 min before recanalization.

Treatment:

Drug: Levosimendan

Bolus and infusion Levosimendan

Active Comparator group

Description:

Levosimendan is given as Bolus (12 µg/kg over 10 min i.v.), starting 10 min before recanalization and additionally as continuous infusion (0.1-0.2 µg/kg/min i. v. for 24 hours).

Treatment:

Drug: Levosimendan