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)

Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2019
INTERVENTION: Trade Name: LEVOSIMENDAN Product Name: Levosimendan Pharmaceutical Form: Concentrate and solvent for solution for injection/infusion INN or Proposed INN: LEVOSIMENDAN CAS Number: 141505‐33‐1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 12.5‐ Pharmaceutical form of the placebo: Infusion Route of administration of the placebo: Intravenous use CONDITION: Perioperative right ventricle dysfunction Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] ‐ Anesthesia and Analgesia [E03] PRIMARY OUTCOME: ; Primary end point(s): . Cardiac function of right ventricle; . miRNAs and cardiac and renal enzymes; ; 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.; ; 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 OUTCOME: ; Secondary end point(s): . Renal IRV ; . EUROSCORE II ; . Arrhythmias; ; Timepoint(s) of evaluation of this end point: 24h ; 48h; INCLUSION CRITERIA: . Patients = 18 years • Patients with preoperative right ventricular dysfunction (TAPSE <17 mm, RV dilatation> 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
Epistemonikos ID: a1ac8eb236402e9cd1017c0798a28bb2588ff020
First added on: Aug 24, 2024