Clinical Trial in Patients Who Have Suffered a Heart Attack and Who Have Undergone Catheterization Treated With Levosimendan

NCT03699215 | Unknown Phase 3 DMC

• 1 other identifier: LEVOCEST
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

Brief Summary

The disease under study is acute coronary syndrome with ST segment elevation, defined as patients presenting chest pain of anginal characteristics of more than 20 minutes of duration, with changes in the electrocardiogram consisting of ST segment elevation of 1 mm in two contiguous limb leads or 2 mm in two contiguous leads precordial. In a review carried out on patients treated in the investigator center with SCACEST, invetsigators found that, in a cohort of 250 patients, 85% of them presented alterations Segments of left ventricular contractility at 4 months after the acute episode. To verify that the Levosimendan administration reduces that percentage, at least 65%, investigators require to include in the study 83 patients in the experimental group and 83 in the control group, for a power of 80% and a confidence level of 95%. Assuming 10% of lost patients, it is required to include in the study 92 patients in the experimental group and 92 patients in the group control .

Conditions

ST Elevation Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• Size of acute myocardial infarction

  percentage myocardium infarct/ left ventricle ventricle

  30 days after acute episode

Secondary Outcomes (3)

• measurement of Biochemical parameters function

  first 24 hours

• electrocardiogram parameters

  1 hour after primary angioplasty

• MAJOR CARDIAC EVENTS

  6 months after angioplasty

Study Arms (2)

placebo

PLACEBO COMPARATOR

solution for intravenous infusion, with similar organoleptic characteristics than active treatment.

Drug: Placebos

levosimendan

EXPERIMENTAL

Concentrate for solution for perfusion. Pack with a 5 ml vial

Drug: Levosimendan

Interventions

Levosimendan DRUG

Upon arrival of the patient in the Coronary Unit, he will receive, in a randomized and double-blind manner, the 24-hour infusion of Levosimendan, without a loading dose, at a dose of 0.1 μg / kg / min or placebo. If the initial dose is tolerated and a greater hemodynamic effect is needed, the infusion rate can be increased to 0.2 micrograms / kg / min. The dose of Levosimendan infusion can be reduced to 0.05 μg / kg / min in case of clinical intolerance or systolic hypotension \<90 mmHg.

levosimendan

Placebos DRUG

continuous perfusion of 0.1 micrograms / kg / min for 24h. If the initial dose is tolerated and a greater hemodynamic effect is needed, the infusion rate can be increased to 0.2 micrograms / kg / min.

placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patients agreed to participate in the study and have signed the informed consent.
• The same patient may not be included more than once.

You may not qualify if:

• Killip IV class in a situation of cardiogenic shock or with TAM values below 65 mmHg of pressure.
• Patients that have suffered a previous heart attack.
• Patients who are being administered amines.
• Patients that do not have segmental disorders of contractility in left ventriculography.
• Mental circumstance that makes you unable to participate in the study.
• Patients that refuse to participate in the study and that they do not sign the informed consent.
• Severe renal impairment (creatinine clearance \<30ml / min)
• Severe hepatic insufficiency - (prothrombin activity rate \<40%).
• History of Torsades de Pointes.
• Acute respiratory distress
• Allergy to levosimendan or some of its components
• Anemia (hemoglobin \<8g / dl)
• Pregnancy

Sponsors & Collaborators

• Hospital Universitario de Canarias: lead

Study Sites (1)

UICEC

San Cristóbal de La Laguna, S/C de Tenerife, 38320, Spain

RECRUITING

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Simendan

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Hydrazones; Hydrazines; Organic Chemicals; Pyridazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Francisco Bosa Ojeda, MD PhD

CONTACT

00 34 922678457; franbosa@ull.edu.es

Consuelo Rodríguez Jiménez, MD PhD

CONTACT

922678573; conrodjim@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2018
• First Posted: October 9, 2018
• Study Start: November 17, 2018
• Primary Completion: April 30, 2020
• Study Completion: December 30, 2021
• Last Updated: February 11, 2021

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)