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Heart Diseases clinical trials

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NCT ID: NCT03925324 Terminated - Clinical trials for Ischemic Heart Disease

Serial Infusions of Allogeneic Mesenchymal Stem Cells in Cardiomyopathy Patients With Left Ventricular Assist Device

STEM-VAD
Start date: May 3, 2019
Phase: Phase 2
Study type: Interventional

A study to assess the safety and preliminary efficacy of serial intravenous dose of Allogeneic Mesenchymal Bone Marrow Cells in subjects with heart failure and implanted left ventricular assist devices.

NCT ID: NCT03923543 Completed - Sepsis Newborn Clinical Trials

Is Neutrophil to Lymphocyte Ratio a Prognostic Factor of Sepsis in Newborns With Operated Congenital Heart Disease

Start date: January 1, 2015
Phase:
Study type: Observational [Patient Registry]

The use of neutrophil lymphocyte ratio is useful for the detection of infection status in newborns after surgery

NCT ID: NCT03917706 Completed - Clinical trials for Congenital Heart Disease

Development of a Quality of Life Assessment Tool for Adult Patients With a Congenital Heart Disease, Having Had Surgery During Childhood

Start date: April 1, 2018
Phase:
Study type: Observational

The mortality due to congenital heart diseases has decreased in recent decades, even for infants with the most complex lesions.Therapeutic advances have prolonged the lifespan of people with these diseases. However, there are specific social and psychological troubles that appear later in life and can compromise employability, insurability and social integration. There are different types of congenital heart disease: those not operated in adulthood, and those operated for curative or palliative purposes. It is estimated that about 10 out of 1000 babies are born with a congenital cardiac malformation. One-third of these have a critical diagnosis requiring a surgical intervention. Data from the literature show that there is an unusually high prevalence of psychosocial, neurological, developmental and psychiatric disabilities among survivors, as they enter formal education.There are many factors that influence developmental outcomes at school age. Early intervention is an essential element in controlling these comorbidities. The continuous monitoring of the development by a multidisciplinary team would make it possible to identify a developmental disorder as soon as it appears and respond to it as quickly as possible.For many children and their families, the burden of the developmental consequences is higher than the daily impact of the heart disease. Most studies and measures of quality of life in congenital heart patients require methodological improvements.They contribute little to the scientific basis of the quality of life in these patients. Future quality of life studies must invest in rigorous conceptualization, adequate operational definition and a good measure of quality of life. The investigators propose to develop a reproducible and reliable quality of life measurement tool, suitable for adult patients suffering from congenital heart disease and having had surgery during childhood.

NCT ID: NCT03913520 Completed - Clinical trials for Congenital Heart Disease

Outcome of Patients With Congenital Heart Disease

OUTCARDIOP
Start date: April 28, 2019
Phase: N/A
Study type: Interventional

Advanced surgical and medical healthcare systems have resulted in an increased prevalence of children and adults with congenital heart disease in Western countries. These patients often necessitate non-cardiac interventions. Previous studies have demonstrated that these patients are at increased risk of morbidity and mortality when presenting for non-cardiac interventions. The aim of this study is to know the prevalence of patients with congenital heart disease presenting for non-cardiac interventions in a tertiary hospital and to determine their outcome.

NCT ID: NCT03912025 Completed - Clinical trials for Congenital Heart Disease

The Relationship Between Having a Positive Mindset and Exercise Capacity in Patients With Congenital Heart Disease

Start date: January 30, 2020
Phase:
Study type: Observational

A cross sectional study utilizing congenital heart disease patients presenting for clinically indicated cardiopulmonary exercise test. Baseline questionnaires (see below) will be administered prior to the exercise test. Exercise test data and clinical data will be recorded. Questionnaire data will be compared to clinical data in and between disease severity groups. Disease severity will be determined based on hemodynamic (not anatomic) classification according to an algorithm adapted from the European Society of Cardiology.

NCT ID: NCT03907891 Active, not recruiting - Covid19 Clinical Trials

Reducing Hopelessness Through Improved Physical Activity in Adults With Heart Disease: With COVID-19 Considerations

Heart Up!
Start date: August 1, 2019
Phase: N/A
Study type: Interventional

After a 30-year decline, heart disease is projected to increase up to 18% by 2030. Participation rates in cardiac rehabilitation remain extremely low and hopeless individuals are less likely to participate. This innovative study has the potential to advance science, improve patient care, and improve patient outcomes by demonstrating the effectiveness of the Heart Up! program to increase physical activity and reduce hopelessness in patients with heart disease. Hopelessness is associated with a 3.4 times increased risk of mortality or nonfatal myocardial infarction in patients with ischemic heart disease (IHD), independent of depression. Hopelessness has been identified in 27-52% of patients with IHD and can persist for up to 12 months after hospital discharge. Hopelessness, a negative outlook and sense of helplessness toward the future, can be a temporary response to an event (state) or a habitual outlook (trait). Hopelessness is associated with decreased physical functioning and lower physical activity (PA) levels in individuals with IHD. While research has investigated strategies to increase PA among IHD patients in general, the study team is the only group to design an intervention to promote PA specifically in hopeless IHD patients. The purpose of this randomized controlled trial is to establish the effectiveness of our 6-week mHealth intervention (Heart Up!) to promote increased PA in hopeless patients with IHD. A total of 225 hopeless IHD patients will be enrolled from a large community teaching hospital in the Midwest. Patients will be randomized (75 per group) to one of three groups: 1) motivational social support (MSS) from a nurse, 2) MSS from a nurse with additional significant other support (SOS), or 3) attention control (AC). It is hypothesized that 1) The MSS with SOS group will have the greatest increase in average minutes of moderate to vigorous PA per day at 8 and 24 weeks as compared to the MSS only or AC groups; 2) Greater increase in minutes of moderate to vigorous PA per day will be associated with decreased state hopelessness levels from baseline to weeks 8 and 24; and 3) Increased social support and increased motivation will mediate the effects of Heart Up! on a greater increase in moderate to vigorous PA at 8 and 24 weeks. The findings from this study could transform care for IHD patients who are hopeless by promoting self-management of important PA goals that can contribute to better health outcomes.

NCT ID: NCT03904901 Recruiting - Anxiety Clinical Trials

Influence of Probiotics in Diabetic Cardiopathies With Excessive Weight

Start date: July 20, 2018
Phase: N/A
Study type: Interventional

Today in Brazil, 6.9% of the population has Diabetes Mellitus 2 (DM2). In the world, there are about 422 million people with DM2. It is a chronic disease of the endocrine system, accounts for 90 to 95% of cases of DM2 and is characterized by defects in insulin action and secretion. Its main cause is linked to obesity and insulin resistance. Obesity is a chronic, multifactorial disease - environmental, nutritional and genetic factors - characterized by excessive accumulation of body fat, and is reaching epidemic proportions, more than 100 million children and 600 million adults worldwide. The number of obese people in Brazil reaches 17.9% of the population. Rates of obesity and DM2 have increased in the last decades, both diseases being associated with inflammation and specific alterations in the intestinal microbiota. Thus, studies show that the use of probiotics may be associated with reduced body weight and reduced glucose in the bloodstream. Probiotics are living microorganisms that, when administered in suitable dosages, confer benefits to the health of the host. In addition, studies show the relationship of the intestinal microbiota and the emergence of various diseases and demonstrate that probiotics can control inflammatory processes, metabolic dysfunctions, normalization of stress-induced behaviors, regulation of the hypothalamic-pituitary-adrenal axis and neuropsychiatric disorders. Thus, the importance of investigating the ingestion of probiotics in relation to anthropometry, biochemical profile and anxiety in diabetic and overweight individuals with cardiopathy are justified. It is a randomized, double-blind, controlled clinical trial. The study will last 3 months and will occur with 74 adult individuals (between 20 and 60 years) of the SUS outpatient clinic of the Institute of Cardiology of Porto Alegre - RS, of both sexes, with BMI above 25 m² / kg. and less than 40 m² / kg, divided into 2 groups and 37 individuals per group. These patients were: Group A (intervention: n = 37): patient received 1 sachet per day of probiotics Lactobacillus acidophilus, Lactobacillus casei, Lactobacillus lactis, Bifidobacterium lactis and Bifidobacterium bifidum for 90 days and Group B (placebo; n = 37): microcrystalline cellulose, lactose, pregelatinized maize starch. Probiotics will contain a dose of 109 CFU in each strain. The excipients used will be: microcrystalline cellulose.

NCT ID: NCT03904589 Completed - Clinical trials for Coronary Heart Disease

Questionnaires Assessing the Quality of Life of Patients Treated for Coronary Heart Disease

Start date: October 11, 2016
Phase:
Study type: Observational

Cardiovascular disease remains the leading cause of death in Europe and worldwide. In 2014, they led to more than 4 million deaths in Europe, and coronary heart disease alone accounts for nearly 1.8 million deaths, or 20% of all deaths in Europe. However, mortality from cardiovascular disease and, especially, coronary heart disease has declined in recent decades. This has been made possible by improving the quality of care provided to patients. Several studies have been conducted to demonstrate this improvement in the quality of care, but they mainly measure the functional results of treatment, morbidity and mortality, survival and prolongation of life. However, patient-centered outcomes such as health-related quality of life outcomes (such as mental function, ability to resume activities of daily living, social relationship) are also considered important outcomes in the management and monitoring of these diseases. Some studies have shown that, even when other risks factors are controlled, a poor quality of life related to health is a prediction factor for morbidity and mortality in patients with coronary artery disease. Some studies have suggested that health-related quality of life should be strongly associated with lifestyle, co-morbidities, and mental function. Some factors have been identified as factors that may affect the quality of life in patients with coronary artery disease, including depression, anxiety, dyspnea and angina pectoris. Depression and anxiety were negatively associated with health-related quality of life in patients with cardiovascular disease. As for dyspnea, it has been shown that in stable patients who have had a myocardial infarction, its increase at 1 month after initiation of treatment is strongly associated with a decrease in the quality of life and with an increased risk of re-hospitalization and death. It is therefore important to measure these factors when the quality of life is assessed in patients with coronary heart disease. The importance of assessing quality of life is that the clinician and the patient often have different concerns: what the clinician considers to be a "successful procedure" is not always considered as such by the patient. Results related to quality of life (results rarely evaluated) are among the results that really interest the patient. Indeed, many patients consider the quality of additional years of life acquired as important as the lifespan, so the goal of today's medicine is to improve the quantity and quality of life of the additional years of life acquired. To ensure this improvement, the assessment of health-related quality of life should be integrated into the daily clinical practice of coronary heart disease management. The objective of our study is to evaluate the feasibility of this practice throughout the traject of care, by using several standardized questionnaires.

NCT ID: NCT03902717 Completed - Surgery Clinical Trials

Patient-centered and Clinical Outcomes After Minimally Invasive Cardiothoracic Surgery

Start date: November 25, 2019
Phase:
Study type: Observational

Nowadays, minimally invasive cardiothoracic surgery techniques are being performed to treat patients with coronary heart diseases. These newly developed procedures include laparoscopic techniques that do not require median sternotomy, which has several beneficial effects for both patient and the hospital. Although retrospective data show promising results with respect to clinical outcomes (e.g. 30-day mortality rate, intensive care unit length of stay), no prospective data with respect to patient centered outcomes (e.g. quality of recovery, quality of life) are available yet. Therefore, the aim of this observational prospective study is to explore several patient centered and clinical outcomes of patients that are treated with these newly developed minimally invasive cardiac procedures. The comparative group consists of patients undergoing open CABG (invasive) and patients undergoing a Transcatheter Aortic Valve Implantation (TAVI).

NCT ID: NCT03897140 Completed - Cardiac Disease Clinical Trials

Point-of-Care Echocardiography With Assistance Technology

Start date: March 25, 2019
Phase: N/A
Study type: Interventional

Establish the effectiveness of the Bay Labs, Inc. EchoGPS software in enabling RNs to acquire echocardiograms. In this study an echocardiogram protocol using the EchoGPS interface with the Terason uSmart 3200t, an FDA 510(k)-cleared, commercially available ultrasound device will be performed. Participants will have two scans, one by a registered nurse (RN) using the Terason uSmart 3200t with EchoGPS (Study Exam) and one by a sonographer using the Reference Device without EchoGPS guidance (Control Exam), under the same protocol. Study is non-significant risk (NSR).