View clinical trials related to Heart Valve Diseases.
Filter by:Aortic valve disease causes impaired let ventricular function (LVF) due to hypertrophy, dilatation and diffuse myocardial fibrosis yet the prognostic effect of fibrosis, waiting time for operation and postoperative exercise training is presently unknown. The investigators aim to (1) determine the changes in LVF for patients on the waiting list; (2) establish non-invasive diagnostics for diffuse myocardial fibrosis; (3) relate LVF to fibrosis and physical capacity. The unique design (echocardiography, cardiopulmonary exercise test, cardiac magnetic resonance tomography and myocardial biopsy on the same patients) makes it possible to establish relationship between results of histology and imaging; quantifying and qualifying fibrosis in vivo, evaluate LVF vs. general cardiopulmonary function and optimize health care prior to and after operation.
Investigators are planning a single center pilot randomized controlled trial to assess the potential of a Cytoadsorbant filter (Cytosorb®, Germany) to remove cytokines from the blood during cardiac surgery. Investigators will screen all patients undergoing cardiac surgery and approach those deemed at risk of post surgical complications [≥ 1 among: age >75 years old, double valvular replacement, complex surgery with expected CPB time >100 min, redo cardiac surgery, pre-op chronic renal failure (plasma creatinine level >120 mcmol/l) or chronic heart failure (LVEF <35%)]. Patients with end-stage renal disease (dialysis dependence), undergoing an emergency procedure or an off-pump procedure, those who decline informed consent as well as those enrolled in another conflicting study will be excluded. Eligible patients will be approached, consented and enrolled in the trial. Patients will then be randomized to either receive conventional CPB (control arm) or CPB plus Cytosorb (intervention arm). The target population is 30 patients (15 per arm). For this pilot study, investigators main outcome will be differences between the two arms in measurement of serum levels for IL-2, IL-6, IL-10 and TNF alpha at baseline (pre-operatively), on ICU admission, as well as 6 and 24 hrs post CPB. Secondary outcomes will be changes in coagulation factors serum levels, the need for vasopressors, inotropes, mechanical ventilation and renal replacement therapy, ICU and hospital length of stay as well as in-hospital mortality. Recruitment period should span from May 2016 to April 2017.
The study aims at the comparative examination of pre-, intra- and post-operative release profiles of inflammatory and vasoactive mediators in patients undergoing heart valve surgery under cardiopulmonary bypass (CPB) due to either infectious endocarditis or degenerative valvular heart disease. Specific attention will focus on the distinction between mediator release associated with infection and that resulting from CPB. Concomitantly identification and characterization of infectious pathogens in the circulation and in valvular samples will be carried out, together with the search for resistance-coding transcripts.
This is a single-center, single-blind, all comer, randomized controlled trial. Patients scheduled for isolated aortic valve replacement (AVR) due to aortic stenosis at "Virgen de la Victoria Universitary Hospital", Málaga, Spain, will be eligible. Ninety-six patients will be randomly assigned to either partial upper sternotomy (ministernotomy, 48 patients) or full sternotomy AVR (48 patients). Sample size was determined for an Alpha error of 0.05,and Beta error of 0.1 for a power of 90% in detecting 0.10 difference points in quality of life EQ-5D-5L-index or 10 points in EQ-5D-5L-Visual Analogic Scale (QOL).
Ischemic reperfusion injury of cardiopulmonary bypass and postoperative renal dysfunction is a common problem which influence poor outcome in subjects undergoing valvular heart surgery. The incidence of postoperative renal dysfunction was reported as high as 7~8% in heart surgery using bypass, and is thought to be caused by ischemia/reperfusion injury. Remote ischemic postconditioning was also reported to be protective for ischemic/reperfusion injury in previous animal studies and stoke patients. Therefore, the investigators are trying to evaluate the clinical effect of remote ischemic postconditioning on postoperative renal dysfunction in subjects undergoing valvular heart surgery with bypass.
The purpose of this study is to investigate whether biomarkers of cell senescence and aging can predict the development of acute kidney injury following cardiac surgery.
Bicuspid Aortic Valve (BAV) is the most common congenital heart disease affecting 1-2% of the population. The aortic dilation and aortic valve degeneration are common complications in patients with BAV. Statins have shown a reduction in the expression of metalloproteinases of the extracellular matrix observed in aortic aneurisms. Several retrospective studies have suggested the benefit of the statins to reduce aortic dilation in patients with BAV. Moreover, although statins did not show to be useful in the progression of aortic stenosis, different studies have suggested a higher profit when the valve affection is not severe. The objective of this study is to determine whether atorvastatin is effective at reducing the progression of aortic dilation in patients with BAV.
A single-center prospective interventional trial. Patients implanted with a sutureless bioprosthetic aortic valve at Karolinska University Hospital in Stockholm, Sweden from 2012 will be eligible. 4-dimensional volume-rendered computed tomography (CT) of the heart will be performed. The aim of the CT is to assess valve leaflet motion. Results of the CT examination, preoperative clinical characteristics, and postoperative clinical data will be registered. Data will be collected prospectively and retrospectively. Informed consent will be obtained from patients meeting the inclusion criteria before the initiation of any study-specific procedures.
4 consecutive days with volunteers between the first and fourth postoperative period of cardiac valve replacement. The volunteers are randomized into 2 groups: the Control Group submitted to cardiac rehabilitation protocol of the hospital where it will be conducted the study, which consists of respiratory and metabolic exercises. The second group, called Early Mobilization Group in addition to the aforementioned exercises will be added exercise in cycle ergometer. For the implementation of rehabilitation protocol in the early mobilization group volunteers will be placed in a sitting position in the bed with the backrest raised to 45 °. The exercise in cycle ergometer will be held for 20 minutes on four consecutive days of active mode, the training load shall be such that the voluntary maintained throughout training a level of fatigue, maintaining level of heart rate predicted for age increased by 70% and 1 w / cm2 every minute to keep the parameter within the standards. The evaluation of heart rate variability with the Polar monitor RS800CX brand model before surgery was performed first postoperative day and fifth postoperative day in the control groups and early mobilization.
Patients that have cardiac surgery may suffer from unrecognized cerebral ischemia or loss of blood flow to the brain temporarily during surgery. This temporary loss of blood flow to the brain may result in a condition called delirium. Delirium is a type temporary confusion. There are some strategies that can help reduce cerebral ischemia during cardiac surgery which can help lead to a reduction in the incidence of delirium. The investigator believes that a strategy called remote ischemic preconditioning will help to reduce the incidence of delirium incidence after cardiac surgery. Remote ischemic preconditioning is a brief exposure to ischemia. This brief exposure to ischemia occurs in an area of the body that is not undergoing a procedure. This brief exposure to ischemia is not long enough to cause any damage to the body and it has been demonstrated to help protect against more severe ischemic injury that may occur later during surgery. In this study the investigator will use remote ischemic preconditioning to see if it can reduce the incidence delirium after cardiac surgery.