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Heart Diseases clinical trials

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NCT ID: NCT05911191 Not yet recruiting - Clinical trials for Exercise Based Prehabilitation in Valvular Surgery

Preoperative Strength-resistance Training in Valvular Heart Disease Patients

CardiacEBPhb
Start date: July 1, 2023
Phase: N/A
Study type: Interventional

Cardiovascular diseases (CVD) are a group of illnesses that include coronary heart disease, cerebrovascular disease, congenital heart disease, and deep vein thrombosis. CVD is the leading cause of mortality worldwide, representing 31% of deaths. In Spain, CVD caused 24% of all deaths in 2020. Major surgery is often chosen as the treatment of choice for CVD. The concept of fast-track rehabilitation after surgery appeared in the 1970s. Participation in these exercise-based prehabilitation programs may decrease postoperative complications and length of hospital stay. The purpose of the present study is to evaluate whether the implementation of an additional resistance training (RT) prehabilitation protocol within a cardiac exercise-based prehabilitation can reduce ICU length of stay, postoperative complications, and hospital length of stay (LOS). Additionally, the secondary objective is to determine whether a program that includes RT in addition to respiratory and aerobic training can have better effects on ventilatory variables. This study follows the protocol of a prospective, parallel, non-randomized clinical trial. Ninety-six adult patients diagnosed with valvular pathology and who have been scheduled for surgery will be included. The control group will be treated with ventilatory and strengthening of respiratory muscles, as well as aerobic exercise. The experimental group, in addition, will receive RT targeting peripheral muscles. Variables such as hospital stay, quality of life, respiratory values, and exercise capacity will be evaluated. Quantitative variables will be analyzed using a t-test or ANOVA, or Mann-Whitney test if the distribution is non-parametric.

NCT ID: NCT05891210 Not yet recruiting - Clinical trials for Congenital Heart Disease

Nutrition in Congenital Heart Disease

Start date: September 1, 2023
Phase:
Study type: Observational

Congenital heart disease (CHD) defined as anatomic malformation of the heart and great vessels which occurs during intrauterine development irrespective of the age of presentation(1) It is classified into acyanotic and cyanotic depending upon whether the patients clinically exhibit cyanosis(2) . It is the most common human developmental anomaly with a reported prevalence of between 4 to 10 per 1000 live birth (3-6). The variety and severity of clinical presentation depend on the cardiac structures involved and their functional impact (7). Previous studies have found that, although birth weight for gestational age is usually normal in patients with congenital heart disease, young children often present with impaired growth parameters (8,9) The underlying causes of this failure to thrive may be multifactorial including innate growth potential, severity of cardiac underlying disease, increased energy requirements ,decreased nutritional intake, malabsorption and poor utilization of absorbed nutrients .these factor are particularly common and sever in low and middle income countries (11) Several studies suggest that the failure to thrive is associated with poorer cognitive development, learning disabilities, and long term behavioral problems more recently Corbett et al (12) detected a significant association between the severity of growth deficiency and IQ ,whereas Raynor and Rudolf (13) found that 55% of the infants who were failing to thrive exhibited developmental delay .In addition , A study by Reif et al (14) reported that children with a history of failure to thrive were found to have more learning difficulties and evidenced developmental delay at follow up 5 years after the initial presentation(15). Achieving survival is not the only target of clinicians for these patients, appropriate growth, development and improved quality of life are also very important. The management of children with congenital heart disease require multidisciplinary approach,in which the nutritional aspect plays an important role ,an adequate caloric intake, in fact this improve the out come of these patients.(7) This study will asses the nutritional status for patients with congenital heart disease Who are admitted at assiut university hospital children and adopting a protocol for nutritional support for them.

NCT ID: NCT05877755 Not yet recruiting - Cardiac Disease Clinical Trials

Validation of Multi-contrast, High-resolution Cardiac Magnetic Resonance Imaging

CARDIO-IRM
Start date: September 1, 2023
Phase: N/A
Study type: Interventional

Cardiovascular disease (CVD) causes at least 1.8 million European deaths annually, exceeding fatalities from cancer, chronic respiratory disease, and diabetes. Consequently, the fight against CVD has become the main priority of the World Health Organization. In the pursuit of understanding and treating CVD, cardiac magnetic resonance imaging (CMR) has remained the only modality capable of providing a comprehensive assessment of the heart's function and structure without harmful radiation. Unfortunately, current CMR systems remain too slow, too complex, require highly trained specialists and, as such, have presented a barrier to a wider adoption of CMR. The aim of CARDIO-IRM is to unleash the full potential of CMR to transform patient trajectories by introducing a fast, one-click, fully automated, and comprehensive imaging pipeline applicable to diagnosis, prognosis, and therapy selection in cardiology.

NCT ID: NCT05877131 Not yet recruiting - Pregnancy Clinical Trials

Evaluate Efficacy Levobupivacaine 0.125% Versuss Ropivacaine 0.2% in Hemodynamic Alterations in Labor and Fetal Repercussions

Start date: June 1, 2023
Phase: Phase 4
Study type: Interventional

INTRODUCTION: Most studies on analgesia in pregnant women in labor mainly evaluate the effect of anesthetics on pain, mentioning hypotension as a side effect without investigating its impact on fetal well-being. The objective of the present study is to evaluate the efficacy of the use of low doses of local anesthetic (LA) to prevent hemodynamic alterations that manifest as a loss of fetal well-being. METHODOLOGY/DESIGN: It is a randomized clinical trial. Patients will be pregnant women in labor (dilation period) who want epidural anesthesia (EA), who will randomly receive 0.125% levobupivacaine (Group L) versus 0.2% ropivacaine (Group R). In both groups, controls of hemodynamic parameters and their relationship with changes in fetal heart rate (FHR) and cardiotocographic recording (RCTG) will be carried out during the first 60 minutes after the administration of the local anesthetic via the epidural route. In case of hypotension and/or subsequent FHR and RCTG alterations, they will also be recorded. The follow-up period will extend from the moment the patient enters the delivery room and requests epidural anesthesia until the moment the patient is discharged from the delivery room. The percentage of patients with hemodynamic alterations will be evaluated as a primary result, as well as the percentage of patients whose hemodynamic alterations are related to changes in FHR and RCTG, when using low doses of LA. In the following will also be evaluated in relation to analgesia, the onset time, level reached and degree of satisfaction; and various intra and postpartum side effects. DISCUSSION: Both groups of pregnant women in labor will be studied in order to obtain data on the potential impact of the use of low doses of local anesthetic via the epidural route on hemodynamic parameters and the state of well-being of the fetus.

NCT ID: NCT05874128 Not yet recruiting - Cardiac Disease Clinical Trials

PROSPECTIVE EVALUATION OF HEARTFOCUS

HF_01
Start date: July 1, 2023
Phase: N/A
Study type: Interventional

The study's objective is to evaluate if exams, performed with the HeartFocus software by novices, are of sufficient quality to visually analyze the left ventricular size, the left ventricular function, the right ventricular size, and the presence of non-trivial pericardial effusion. Novices will be nurses without prior ultrasound experience who have received dedicated training on cardiac ultrasound and on Heartfocus software. Ultrasound exams will be limited to the acquisition of 10 reference views

NCT ID: NCT05869825 Not yet recruiting - Clinical trials for Congenital Heart Disease

HFNC vs NIPPV Following Extubation

Start date: May 2024
Phase: N/A
Study type: Interventional

This study has the goal to determine the best method of respiratory support following extubation after cardiac surgery (CS). After cardiac surgery for Congenital Heart Disease (CHD), patients remain intubated until the cardiac team determines it is safe for the patient to undergo a trial of extubation. Two common methods of respiratory support following extubation are High Flow Nasal Cannula (HFNC) and Non Invasive Positive Pressure Ventilation (NIPPV). There is currently a gap in data comparing High Flow Nasal Cannula and Non-Invasive Positive Pressure Ventilation in infants (age 0-1) in regard to extubation failure and overall outcomes. This study will monitor the health outcomes of 200 infants (0 - 1 year) with CHD following cardiac surgery in the Cardiac Intensive Care Unit (CICU) at Children's Healthcare of Atlanta (CHOA). This will be done by assigning the respiratory support method each child will receive following extubation after cardiac surgery. Health outcomes will be monitored until discharge or until the second instance of extubation failure. Both study arms are standard-of-care respiratory support methods in the CHOA CICU. The investigators aim to determine which of these two methods has fewer risk factors when used with infants.

NCT ID: NCT05864248 Not yet recruiting - Heart Failure Clinical Trials

Feasibility Study SA of the Supira System for HRPCI

Start date: June 1, 2023
Phase: N/A
Study type: Interventional

The objective is to assess the feasibility and safety of the Supira System in providing temporary cardiovascular hemodynamic support in patients undergoing HRPCI.

NCT ID: NCT05852106 Not yet recruiting - Clinical trials for Congenital Heart Disease

The Effect of 3D Heart Modelling on Family Quality of Life and Surgical Success

Start date: July 1, 2023
Phase: N/A
Study type: Interventional

Introduction and Objective: In recent years, 3D (three-dimensional) modeling has been added to traditional and effective diagnostic methods such as Computed Tomography (CT), Magnetic Resonance Imaging (MRI), and Echocardiography. The purpose of this study is to determine the effectiveness of models created from patients' own radiological images using 3D printing technology in the clinical setting to simulate surgery in the preoperative period and provide preoperative parental education to improve family quality of life and positively influence patient outcomes. Methods: The study is a two-group pretest-posttest randomized controlled study. The children who come to the outpatient clinic examination in a private hospital and who are subjected to Computed Tomography (CT) examination for diagnostic procedures will be modeled in the experimental group, pre-tests will be applied, and the model will be 3D printed after it is approved by the radiologist who is among the researchers. The sample size is 15 experimental group and 15 control group. After the radiologist's approval, surgical simulation and preoperative education will be applied to the experimental group. The control group will receive the same parent education as the standard model. Both groups will complete the Sociodemographic Information Form, Surgical Simulation Evaluation Form - Part I, and Pediatric Quality of Life Inventory (PedsQL) Family Impacts Module one week prior to hospitalization. Surgical simulation and preoperative education will be completed on the same day. On postoperative day 0, only the Surgical Simulation Evaluation Form - Part II will be applied and on postoperative day 15, the Surgical Simulation Evaluation Form - Part II and the Pediatric Quality of Life Inventory (PedsQL) Family Impacts Module will be applied to both groups as a posttest. Pilot Study and Results: Modeling and 3D printing studies were conducted to carry out the study. A total of four diagnosed and treated patients were retrospectively analyzed. An intracardiac anomaly was detected in the patient data taken for the first model. It was decided to model the extracardiac structures since the inside of the heart was filled with blood, and the blood could not be ruled out as a solid structure. Finally, aortic coarctation was modeled clearly from the images taken and completed.

NCT ID: NCT05848934 Not yet recruiting - Clinical trials for Coronary Heart Disease

Research on the Relationship Between Cognitive Function Changes and Cerebrovascular Health in Patients With Coronary Heart Disease

Start date: May 1, 2023
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is to elucidate the imaging mechanisms of cognitive function changes in patients with coronary heart disease before and after surgery or conservative treatment, and to evaluate and predict the postoperative neurological function recovery and cerebrovascular health level of patients by combining serum markers and patient cardiovascular health evaluation indicators.

NCT ID: NCT05846334 Not yet recruiting - Clinical trials for Ischemic Heart Disease

mHealth Intervention to Reduce Perceived Stress in Patients With Ischemic Heart Disease

mStress-IHD
Start date: August 1, 2023
Phase: N/A
Study type: Interventional

Stress is highly prevalent in patients with ischemic heart disease (IHD) and is associated with lower health-related quality of life and worsened cardiovascular outcome. The importance of stress management is now recognized in recent cardiovascular guidelines. However, effective stress management intervention are not implemented in clinical routine yet. The development of easily disseminated eHealth interventions, particularly mHealth, may offer a cost-effective and scalable solution to this problem. The aim of the proposed trial is to assess the efficiency and cost-effectiveness of the mHealth intervention 'mindfulHeart' in terms of reducing stress in patients with IHD.