Levosimendan In Patients Undergoing LVAD Implantation

Status Recruiting

Clinical Trial Summary

According to the results from the literature, it has been shown that levosimendan usage 24-48 hours before LVAD implementation can improve short and long-term outcome in these patients regarding to the patients without preoperative pretreatment. The aim is to compare short and long-term outcome in patients who underwent to LVAD implementation and pretreated with levosimendan regarding the patient without pretreatment or with other medications.

Clinical Trial Description

Left ventricular assist device (LVAD) implantation is accepted for treatment of end-stage heart failure, in both as the bridging to heart transplantation or as the destination therapy. These patients have highly impaired systolic function which contributes to global heart dysfunction. The main complication is arising of pulmonary vascular pressures and pulmonary vascular resistance (PVR) and, consequently, right heart dysfunction. From the data in literature, RV dysfunction exist in approximately 25%-40% of patients with implanted LVAD, and in approximately 20%-30% of those died or have need for the RV assist device due to RV failure refractory to medications. Capability of the RV to maintain appropriate output and the fill of the LVAD is the main point for correct LVAD functioning and patients' early and late postoperative outcome. Preimplantation evaluation by echocardiography estimation of RV function, geometry and tricuspid valve function are the criteria for the diagnose of RV dysfunction. Laboratory analysis which can lead to the diagnose of RV dysfunction are also included in preimplantation evaluation. Specific inotropic therapy in patients with moderate or severe RV dysfunction and/or dilatation can improve RV function in preimplantation period. This is predominantly important in patients who were on the prolonged inotropic support with beta-agonist therapy before LVAD implantation and in whom their beta receptors are exhausted. The investigators will exam the hemodynamic effects of levosimendan administrated day before in patients underwent LVAD implantation. Further, investigators will analyze and evaluate early and late outcome in participants with implanted LVAD. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03659851
Study type	Observational [Patient Registry]
Source	University Hospital Dubrava
Contact	Nikola Bradic, MD
Phone	+385 91 589 3480
Email	nbradic@kbd.hr
Status	Recruiting
Phase
Start date	June 1, 2009
Completion date	December 31, 2021

View Details

See also
Status	Clinical Trial	Phase
Enrolling by invitation	`NCT05529654` - IMpella-Protected cArdiaC Surgery Trial (IMPACT)	N/A
Recruiting	`NCT04671966` - Sex Differences in Myocardial Steatosis Induced Left Ventricular Dysfunction	Phase 4
Not yet recruiting	`NCT05188222` - Preoperative Maltodextrin's Effect on Cardiac Function in Cardiac Surgery	Phase 4
Recruiting	`NCT04950218` - The Psoriasis Echo Study
Completed	`NCT01076920` - Mesenchymal Stem Cells and Myocardial Ischemia	Phase 1/Phase 2
Completed	`NCT01128790` - Pilot Study of Remote Ischemic Preconditioning in Heart Failure	N/A
Completed	`NCT04942353` - Effects of Home-based Exercise Rehabilitation on Healthcare Utilization in HeartMate 3 Patients	N/A
Recruiting	`NCT05769036` - Conventional Biventricular Versus Left Bundle Branch Pacing on Outcomes in Heart Failure Patients	N/A
Completed	`NCT03232736` - InterventiOn of Biventricular Pacemaker Function on ventrIcular Function Among Patients With LVAD's
Recruiting	`NCT04694092` - Landiolol for Rate Control in Decompensated Heart Failure Due to Atrial Fibrillation	N/A
Completed	`NCT02013037` - The De-novo Use of Eculizumab in Presensitized Patients Receiving Cardiac Transplantation	Phase 3
Completed	`NCT01609738` - Left Ventricular Septum Pacing in Patients by Transvenous Approach Through the Inter-ventricular Septum	Phase 1/Phase 2
Completed	`NCT00551681` - Effects of Left Ventricular Pacing Optimilization on Cardiac Perfusion, Contractile Force, and Clinical Performance in Patients With Ventricular Dysfunction and Heart Failure	N/A
Not yet recruiting	`NCT04103008` - Left Ventricular Function After Primary Percutaneous Coronary Intervention: Role of Speckle Echocardiography
Completed	`NCT06197256` - Cardiac Dysfunction in Critically Ill Covid-19 Patients
Recruiting	`NCT05860504` - Acute Cardiac Dysfunction in Critical Illnes
Completed	`NCT03787810` - Left Ventricular Dysfunction in Critically Ill Patients
Completed	`NCT01093001` - Tricuspid Regurgitation Study	Phase 4
Active, not recruiting	`NCT00461734` - PROTECT-PACE STUDY - The Protection of Left Ventricular Function During Right Ventricular Pacing	N/A
Recruiting	`NCT04752293` - Pediatric Hypertension and the Renin-Angiotensin SystEm (PHRASE)

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.