Use of levosimendan / placebo as cardio and nephroprotection in patients who are going 0n cardiac surgery with right ventricular dysfunction

Mechanisms of cardio and nephroprotection in patients who are going on cardiac surgery with right ventricular dysfunction, with preoperative treatment of levosimendan compared with placebo. (PRELEVD-Pilot Study)

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-004063-31-ES

Enrollment

Registered

2019-01-22

Start date

2019-04-26

Completion date

Unknown

Last updated

2019-06-30

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

Conditions

Perioperative right ventricle dysfunction

Interventions

Trade Name: LEVOSIMENDAN Product Name: Levosimendan Pharmaceutical Form: Concentrate and solvent for solution for injection/infusion INN or Proposed INN

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: . Patients = 18 years • Patients with preoperative right ventricular dysfunction (TAPSE 39 mm, tricuspid annulus dilatation> 40 mm), diagnosed by preoperative transthoracic echocardiography. • Give informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: . History of adverse event related to levosimendan. • Patients in a situation of hemodynamic instability. • Preoperative renal dysfunction, estimated through the preoperative GFR rate (creatinine clearance 4 mmol / L) • TAS before the infusion <100 mmHg (recommendation of the Spanish Society of Cardiology) • Some serious situation at the discretion of the researcher.

Design outcomes

Primary

Measure	Time frame
Primary end point(s): . Cardiac function of right ventricle . miRNAs and cardiac and renal enzymes ; Timepoint(s) of evaluation of this end point: 24h 48h ;Main Objective: Evaluate the cardiological and renal effects of the preoperative administration of levosimendan in patients with right ventricular dysfunction who are going to undergo cardiac surgery and evaluate enzymatic routes, and of two of the main miRNAs (21 (related to the increase with renal dysfunction and poor evolution in patients with right ventricular dysfunction and pulmonary hypertension) and 133b (related to right ventricular dysfunction and increased stress or suffering in upward regulation), related to the effects of cardioprotection and pharmacological nephropreservation.; Secondary Objective: To assess whether there are differences between patients in the renal and IRV flows measured by baseline renal ultrasound and at 48 hours in those patients who were given the preoperative levosimendan; and then compare them with those to whom the drug was not administered. To assess if there are differences in the incidence of arrhythmias in each group. Evaluate variations in the EUROSCORE II scale after treatment with levosimendan.	—

Measure

Time frame

Primary end point(s): . Cardiac function of right ventricle . miRNAs and cardiac and renal enzymes ; Timepoint(s) of evaluation of this end point: 24h 48h ;Main Objective: Evaluate the cardiological and renal effects of the preoperative administration of levosimendan in patients with right ventricular dysfunction who are going to undergo cardiac surgery and evaluate enzymatic routes, and of two of the main miRNAs (21 (related to the increase with renal dysfunction and poor evolution in patients with right ventricular dysfunction and pulmonary hypertension) and 133b (related to right ventricular dysfunction and increased stress or suffering in upward regulation), related to the effects of cardioprotection and pharmacological nephropreservation.; Secondary Objective: To assess whether there are differences between patients in the renal and IRV flows measured by baseline renal ultrasound and at 48 hours in those patients who were given the preoperative levosimendan; and then compare them with those to whom the drug was not administered. To assess if there are differences in the incidence of arrhythmias in each group. Evaluate variations in the EUROSCORE II scale after treatment with levosimendan.

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Secondary

Measure	Time frame
Secondary end point(s): . Renal IRV . EUROSCORE II . Arrhythmias ; Timepoint(s) of evaluation of this end point: 24h 48h	—

Countries

Spain

Contacts

Public ContactClinical Studies Platform

FIMABIS

gloria.luque@fimabis.org34951291977

Outcome results

None listed

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