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

Ensayo clínico, Fase III, Aleatorizado, Prospectivo, unicéntrico, Doble Ciego y Controlado Con Placebo, Para Estimar la Eficacia y Seguridad Del Levosimendan Intravenoso, en Las Primeras 24 Horas Tras la Angioplastia Primaria, en Pacientes Con síndrome Coronario Agudo Con elevación Del Segmento ST

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 .

Study Overview

• Status: Unknown
• Conditions: ST Elevation Myocardial Infarction
• Intervention / Treatment: Drug: Placebos; Drug: Levosimendan

Detailed Description

The patients will be included randomly, until the calculated sample size is completed. A recruitment period of 12 months is estimated from the beginning of the study. From the date of inclusion of the first patient, the final duration of the study will be 1.5 years.

The study will end when performing the last cardio-resonance and echocardiography that should be performed 6 months after the inclusion of the last patient in the study.

Upon arrival of the patient at the Coronary Unit, he will receive, in a randomized and double-blind manner, without a loading dose, the 24-hour infusion of Levosimendan, or placebo.

The continuous infusion of levosimendan 0.1 micrograms / kg / min will be administered during 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. The dose of Levosimendan infusion can be reduced to 0.05 μg / kg / min in case of clinical intolerance or systolic hypotension <90 mmHg.

Continuous perfusion of the placebo 0.1 micrograms / kg / min will be administered 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. The dose of infusion of the placebo can be reduced to 0.05 μg / kg / min in case of clinical intolerance or systolic hypotension <90 mmHg.

• Study Type: Interventional
• Enrollment (Anticipated): 184
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Francisco Bosa Ojeda, MD PhD; Phone Number: 34457 00 34 922678457; Email: franbosa@ull.edu.es
• Study Contact Backup: Name: Consuelo Rodríguez Jiménez, MD PhD; Phone Number: 922678573; Email: conrodjim@gmail.com

Study Locations

• Spain
  • S/C De Tenerife
    • La Laguna, S/C De Tenerife, Spain, 38320
      • Recruiting
      • UICEC
      • Contact: Consuelo Rodríguez Jimnénez, PhD, MD; Phone Number: 922678175; Email: conrodjim@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: placebo; solution for intravenous infusion, with similar organoleptic characteristics than active treatment.	Drug: Placebos; 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.
EXPERIMENTAL: levosimendan; Concentrate for solution for perfusion. Pack with a 5 ml vial	Drug: Levosimendan; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Size of acute myocardial infarction	percentage myocardium infarct/ left ventricle ventricle	30 days after acute episode

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
measurement of Biochemical parameters function	troponine, creatinkinase, creatinkinase-MB	first 24 hours
electrocardiogram parameters	Residual ST segment deviation	1 hour after primary angioplasty
MAJOR CARDIAC EVENTS	need of revascularitation or cardiac death	6 months after angioplasty

Collaborators and Investigators

• Sponsor: Hospital Universitario de Canarias

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 17, 2018
• Primary Completion (ACTUAL): April 30, 2020
• Study Completion (ANTICIPATED): December 30, 2021

Study Registration Dates

• First Submitted: September 27, 2018
• First Submitted That Met QC Criteria: October 4, 2018
• First Posted (ACTUAL): October 9, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 11, 2021
• Last Update Submitted That Met QC Criteria: February 10, 2021
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; ST Elevation Myocardial Infarction; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Enzyme Inhibitors; Protective Agents; Cardiotonic Agents; Phosphodiesterase Inhibitors; Phosphodiesterase 3 Inhibitors; Simendan
• Other Study ID Numbers: LEVOCEST

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No