Active clinical trials for "Heart Diseases"

This study is a randomized clinical trial where participants (parents of a fetus or neonate diagnosed with a life-threatening congenital heart disease (CHD)) will randomly be assigned to either receiving a web-based decision aid (DA) alone, or receiving the decision aid that includes a values clarification exercise. Because of the novel use of decision aids in CHD in an acute setting, we will also compare participants receiving the DA in a randomized control trial to a prospective observational population of families faced with similar decisions without a DA (control group). We have designated the Brief Symptom Inventory Global Severity Index of Global Distress 3 months post-birth or death/termination as our primary outcome measure.

Today, 50 % of cardiac patients do not participate in cardiac rehabilitation due difficulties in navigating and accessing rehabilitation activities. HeRTA is a partnership project involving Center for Clinical Research and Prevention (CCRP), Hvidovre Hospital, Rehabilitation Center Albertslund and Copenhagen (municipalities), the Danish Heart Association, and local sports associations. A patient advisory board participate throughout the project to ensure a continued focus on patient interests. The overall aim of HeRTA is to develop and test the feasibility of a new, sustainable model for rehabilitation supporting patients to take part in rehabilitation and promoting life-long activity for all patients with heart disease. To ensure equal access to rehabilitation some activities are open to all patients, while others are tailored specifically to patients with vulnerability. The project unfolds in three phases: Development (1. January 1. 2020 - 14. November 2021): Partners and patients co-create content and procedures; Feasibility (15. November 2021 - 31. July 2023): The feasibility of the model is tested, and promising components are identified; Long-term follow-up and implementation (1. August 2023 - 31. December 2025): Long term effects are investigated and promising components are tested in new settings. During the feasibility phase the investigators will examine whether the intervention activities are feasible, acceptable, and may have positive effects for patients with heart disease. The investigators use qualitative data on implementation and acceptability of intervention among partners and patients. An randomisered controlled trial (RCT) component will assess effects on patient participation rates, health, physical activity level, and life quality. Data is collected from practitioners and patients through focus groups, observations, field notes, questionnaires, and interviews. Results will point to: innovative ways to organize integrated rehabilitation pathways. approaches to ensuring rehabilitation targeted at patient needs.

This project implements an eHealth intervention targeted at vulnerable infants with cardiac disease and specifically study how this intervention impact their parents coping, stress levels and personal wellbeing. The intervention will be evaluated through a randomized controlled trial (RCT). The aim of this project is therefore to measure if the features of this mobile application are useful for parents' assessment of deterioration, decision-making and communication with health care providers.

This study will conduct a two-arm randomized controlled trial to test the efficacy of a culturally tailored version of the NYU Caregiver Intervention (NYUCI) plus enhanced support (ES) through online chat groups (the NYUCI plus WeChat/Kakaotalk [population social media app for Chinese/Korean] peer support which we call the NYUCI-ES in reducing health risks for cardiometabolic disease among older Chinese and Korean American adults caring for relatives with ADRD. In collaboration with community organizations across the New York and northern New Jersey metropolitan area, we will enroll 300 caregivers of people with ADRD (150 Chinese and 150 Korean) in this study. Aim 1: Develop culturally adapted informational and educational materials about dementia and caregiving issues for social service providers of the intervention and for family caregivers. Aim 2: Test the hypothesis, H1: A counseling and support intervention (the NYUCI-ES) will significantly improve psychosocial factors such as depression, stress self-rated health and chronic disease management among Chinese and Korean-American ADRD caregivers and these changes will be mediated by improvement in social support. H1a: By the first (6- month) follow-up, the mediators (increases in social support, stress reaction) will improve significantly in the intervention group compared to baseline values and the control group. H1b: These improvements will be maintained, and lead to reduction in depressive symptoms, and improvement in self-reported health and chronic disease self-management by the 12-month follow-up compared to the control group. Aim 3: Test the hypothesis, H2: the NYUCI-ES will reduce biologic risk factors, including metabolic health (glycosylated hemoglobin) and inflammation (Oxidative stress, lipid metabolism, etc.) within 6 months of enrollment compared to baseline and a control group; these changes will be mediated through increases in social support and decreases in depressive symptoms and will be maintained at the 12-month follow-up. The public health significance of these findings will likely have an impact on health care policy for CGs from diverse underserved ethnic and cultural backgrounds, potentially reducing morbidity, and improving their quality of life.

Considering decrease of major complications and improvement of procedural results, conductive disorders currently remain the main issue after TAVR (Transcatheter aortic valve replacement). While pacemaker implantation rate was about 10-15%, new onset LBBB (Left bundle branch block) was observed in 30 % of patients after TAVR but resolved at discharge in the majority of them, with less than 20% progressed to complete AV (atrioventricular) block requiring permanent pacing at hospital discharge. Higher implantation and improvement of the devices were associated with decline of pace maker implantation rate over the years in experienced teams. While guidelines do not give definite recommendation regarding conductive disorder management and pacemaker indication, a strategy of selective telemetry monitoring (TM) after TAVR according to the risk of conductive disorders may be proposed to limit indication and lenght of stay of intensive care unit admission (ICU), allowing direct admission of lower risk patients in general cardiology ward (GCW) without TM, to decrease the duration of TM when a conductive disorder is stable or regressive and finally to decrease the rate of pacemakers implantation. Potential benefit may also include limitation of ICU overload in high volume TAVR centers, investigators can also expect shorter hospitalization duration, with potential economic impact, in line with the development of algorithms for fast track procedures. Therefore the main objective of our prospective study was to evaluate feasibility and safety of a strategy of management of conductive disorders after TAVR based on an algorithm of diagnosis, monitoring and therapeutic strategies based on ECG analysis.

Congenital heart disease (CHD) is the most common birth defect and is increasingly diagnosed prenatally. Mothers describe their prenatal experiences as highly stressful and traumatic after a diagnosis of CHD. Maternal stress during pregnancy exerts a powerful influence on birth outcomes and developmental trajectories, particularly for children in underserved populations. In partnership with diverse parent and clinician stakeholders, our team designed HEARTPrep, an innovative, virtually-delivered psychosocial intervention for mothers expecting a baby with CHD. This project will pilot HEARTPrep with mothers expecting a baby with CHD to obtain preliminary data for a larger future trial. This intervention has the potential to improve emotional wellbeing in mothers expecting a baby with CHD, thereby altering developmental trajectories for this large population of children.

Safety and performance evaluation of the preCARDIA System for patients with ADHF.

The purpose of this study is to examine the effect of a brief electronic shared decision making (eSDM) intervention on depressive symptoms in coronary heart disease patients with elevated depressive symptoms.

The proposed study will be a prospective, randomized, double blind, placebo controlled trial to compare the use of a continuous infusion versus intermittent ketorolac on postoperative patients in the pediatric cardiovascular ICU. We intend to determine if the continuous infusion leads to a decreased utilization of opiates when compared to intermittent ketorolac.

Rural patients with life-limiting illness are at very high risk of not receiving appropriate care due to a lack of health professionals, long distances to treatment centers, and limited palliative care (PC) clinical expertise. Secondly, although culture strongly influences people's response to diagnosis, illness and treatment preferences, culturally-based care models are not currently available for most seriously-ill rural patients and their family caregivers. Lack of sensitivity to cultural differences may compromise PC for minority patients. The purpose of this study is to compare a culturally-based Tele-consult program to usual hospital care to determine whether a culturally-based PC Tele-consult program leads to lower symptom burden in hospitalized African American and White older adults with a life-limiting illness.