Clinical trial in patients who have suffered a heart attack and who have undergone catheterization treated with mild-simendan.

Clinical trial, Phase III, randomized, prospective, unicentric, double-blind and placebo-controlled, to estimate the efficacy and safety of intravenous Levosimendan, in the first 24 hours after primary angioplasty, in patients with acute coronary syndrome with ST-segment elevation.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-003843-39-ES

Enrollment

184

Registered

2018-01-17

Start date

2018-03-27

Completion date

Unknown

Last updated

2023-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute coronary syndrome with ST-segment elevation MedDRA version: 20.0 Level: PT Classification code 10000891 Term: Acute myocardial infarction System Organ Class: 10007541 - Cardiac disorders

Interventions

Trade Name: SIMDAX Product Name: LEVOSIMENDAN Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: LEVOSIMENDAN CAS Number: 141505-33-1 Concentration unit: mg/ml milligram(s

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients of both sexes who come to CHUC. Age between 18 and 85 years old. Symptoms of STEMI over 30 minutes and less than 12 hours of evolution. ST segment elevation of >= 1 mm in two contiguous limb leads or >= 2 mm in two contiguous precordial leads. That they agreed to participate in the study and have signed the informed consent. The same patient may not be included more than once. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 84 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100

Exclusion criteria

Exclusion criteria: Class Killip IV in cardiogenic shock situation or with Arterial Pressure below 80 mmHg systolic pressure. That they had a previous heart attack. who don't have contractility disorders on their left ventriculography. Mental circumstance that makes you unable to participate in the study. Refuse to participate in the study and not sign an informed consent form. Severe renal failure (creatinine clearance < 30ml/min) Severe liver failure (define). History of Torsades de Pointes. Acute respiratory distress Allergy to levosimendan or some of its components Anemia (hemoglobin < 8g/dl) Pregnancy

Design outcomes

Primary

Measure	Time frame
Primary end point(s): Size of AMI (percentage myocardium infarct / percentage of the left ventricle) estimated by cardioresonance and quantified by late enhancement of gadolinium at 30 +/- 10 days of acute episode in both treatment, active and placebo groups.;Main Objective: To assess whether blunt myocardium, following acute myocardial infarction with ST-segment elevation, can be fully or partially recovered after infusion of levosimendan in the first 24 hours after primary angioplasty.;Secondary Objective: 1. Left ventricular function. 2. Adverse ventricular remodeling. 3. Heart failure. 4. Arrhythmias. 5. Hypotension. 6. Reinfarct 7. Ischemic events.;Timepoint(s) of evaluation of this end point: At 30 +/- 10 days of acute episode in both treatment, active and placebo groups.	—

Measure

Time frame

Primary end point(s): Size of AMI (percentage myocardium infarct / percentage of the left ventricle) estimated by cardioresonance and quantified by late enhancement of gadolinium at 30 +/- 10 days of acute episode in both treatment, active and placebo groups.;Main Objective: To assess whether blunt myocardium, following acute myocardial infarction with ST-segment elevation, can be fully or partially recovered after infusion of levosimendan in the first 24 hours after primary angioplasty.;Secondary Objective: 1. Left ventricular function. 2. Adverse ventricular remodeling. 3. Heart failure. 4. Arrhythmias. 5. Hypotension. 6. Reinfarct 7. Ischemic events.;Timepoint(s) of evaluation of this end point: At 30 +/- 10 days of acute episode in both treatment, active and placebo groups.

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Secondary

Measure	Time frame
Secondary end point(s): Echocardiographic and cardioresonance parameters related to cardiac function;Timepoint(s) of evaluation of this end point: At 30 days and 6 months	—

Countries

Spain

Contacts

Public ContactConsuelo Rodríguez Jiménez

Complejo Hospitalario Universitario de Canarias

crodjimw@gobiernodecanarias.org0034922678573

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026