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Heart Defects, Congenital clinical trials

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NCT ID: NCT04138745 Completed - Clinical trials for Congenital Heart Disease

Transverse Thoracic Plane Block in the Pediatric Cardiac Patient

TTPPCT
Start date: January 1, 2018
Phase:
Study type: Observational

Postoperative pain after cardiothoracic surgery can be a significant problem interfering with recovery, yet difficult to manage due to the sedating effects of opiates. These patients frequently have associated postoperative pulmonary changes and are at risk of respiratory depression with opioid analgesia. The ultrasound-guided transversus thoracic muscle plane block (TTMPB) is a recently described regional anesthetic technique showing improvements in postoperative pain management. Further investigation is needed to establish the potential of the TTMPB as an analgesic modality in congenital cardiothoracic surgery in patients under the age of 18.

NCT ID: NCT04136379 Completed - Clinical trials for Congenital Heart Disease

Comparison of Home and Standard Clinic Monitoring of INR in Patients With CHD

Start date: September 30, 2019
Phase:
Study type: Observational

Summary: Congenital heart disease (CHD) is the most prevalent form of birth defect with a global rate of 1.35 million newborns born with CHD annually. Patients with CHD have an increased risk of cerebrovascular accident (CVA) compared to age-matched control populations. Anticoagulation with warfarin is the mainstay of antithrombotic treatment in these patients and requires frequent monitoring of the International Normalized Ratio (INR). The CoaguChek monitor is a point of care device that enables patients to self-monitor and manage their INR without the need to attend a warfarin clinic. The aim of this study is to compare the efficacy and outcomes of standard clinic management and home management of INR in patients with CHD. Analysis of time in therapeutic range (TTR), INR variability, major and minor bleeding events, incidence of CVA and other thrombotic events will be undertaken. Original Hypothesis: There will be a difference in the proportion of time that patients spend in their therapeutic range and the amount of adverse events that occur between those who use a CoaguChek monitor and those who use standard clinic monitoring of their INR. The primary outcome will be time in therapeutic range (TTR). Secondary outcomes will be INR variability, minor / major bleeding complications and thromboembolic events.

NCT ID: NCT04135859 Completed - Physical Activity Clinical Trials

Young Adult Congenital Heart Disease Physical Activity Lifestyle Study (YACHD-PALS)

YACHD-PALS
Start date: March 14, 2019
Phase: N/A
Study type: Interventional

This study will adapt a physical activity lifestyle intervention to emerging adult congenital heart disease (CHD) survivors with the primary goal of increasing physical activity levels. The study will be split into 2 phases. In Phase 1, participants will be asked to complete questionnaires, wear an accelerometer around the waist for 7 days, and undergo an exercise stress test. The accelerometer and exercise stress test will be used to determine whether participants are eligible to be randomized for the intervention study. In Phase 2, participants will be randomized to one of two conditions: 1) receiving a physical activity tracker (a Fitbit) or 2) receiving a Fitbit AND engaging in videoconferencing sessions with a physical activity coach. During Phase 2, participants will also be asked to complete 3 assessments (weeks 9 and 22, and a 6-month follow-up). The week 9 assessment will consist of completing questionnaires and wearing an accelerometer for 7 days. Week 22 will be similar to week 9 with the addition of a final exercise stress test. The 6-month follow-up will mirror the week 9 assessment. Participants who are randomized to the videoconferencing condition will be asked to meet with a physical activity coach 8 times over the course of 20 weeks. Coaches will help participants to (1) change attitudes toward physical activity, (2) increase perception of others' approval of physical activity (e.g., family members, peers), and (3) increase participants' perceived control by troubleshooting barriers and increasing efficacy for physical activity. Coaches will use the Fitbit to facilitate self-monitoring and goal setting. Participants in the intervention arm will be asked to participate in a focus group at the conclusion of the study to share their experiences.

NCT ID: NCT04130243 Active, not recruiting - Clinical trials for Pulmonary Arterial Hypertension

Biomarkers in Pediatric Congenital Heart Disease and PAH

Start date: December 5, 2017
Phase:
Study type: Observational [Patient Registry]

Nowadays, biomarkers are broadly used in clinical practice. Blood-derived biomarkers fulfil an important role in the field of cardiology. However, most biomarkers have been investigated for adult left ventricular disease. In congenital heart diseases (CHD) and pulmonary arterial hypertension (PAH), which involves children and mostly the right ventricle, less is known about the clinical and predictive value of blood-derived biomarkers. Since the group of survivors of CHD and PAH is growing because of the improved techniques nowadays, development of better tools to maintain the quality of life for the longer term in these patients is urgently needed. Blood-derived biomarkers are minimally invasive biomarkers, are quantitative and have shown to be able to reveal pathological processes in an early stage. Hence, blood-derived biomarkers may be a good addition to current diagnostic means in CHD and PAH. Objective: The primary objective of this study is to investigate cross-sectionally the association between various emerging blood-derived biomarkers and right ventricular (RV) function:defined as tricuspid annular plane systolic excursion (TAPSE) measured with echocardiography, in children with (a history of ) an abnormally loaded, volume and/or pressure loaded, right ventricle associated with CHD and/or PAH.

NCT ID: NCT04125550 Completed - Clinical trials for Cyanotic Congenital Heart Disease

Propofol vs Sevoflurane in Cyanotic Congenital Heart Disease

PSI
Start date: January 1, 2020
Phase: Phase 4
Study type: Interventional

The stress response to surgery compromises a series of humoral, metabolic, or cellular reactions. Cardiac surgery with use of cardiopulmonary bypass (CPB) is a major activator of the systemic inflammatory response (SIRS). Inflammation, resulting in neutrophil activation, plays a central role in the production of reactive oxygen species (ROS). Inflammatory and oxidative reactions may play a role in the more frequent observation of postoperative ventricular dysfunction in patients with cyanotic congenital heart disease (CHD) undergoing surgery. The aim of this study is to compare the anti-inflammatory and anti-oxidant effects of propofol and sevoflurane in children with cyanotic CHD undergoing open heart surgery with CPB.

NCT ID: NCT04106479 Recruiting - Tetralogy of Fallot Clinical Trials

NIRS in Congenital Heart Defects - Correlation With Echocardiography

Start date: October 11, 2019
Phase:
Study type: Observational

Neonatal patients with congenital heart defects (CHD) have changing physiology in the context of transitional period. Patients with CHD are at risk of low perfusion status or abnormal pulmonary blood flow. Near infrared spectroscopy has been used in neonatal intensive care units (NICU) to measure end-organ perfusion. The investigator plan on monitoring newborns with CHD admitted to the NICU with NIRS and echocardiography during the first week of life and correlate measures of perfusion from Dopplers to cerebral and renal NIRS.

NCT ID: NCT04106154 Completed - Chronic Pain Clinical Trials

Impacting Children's Physical and Mental Health Through Kinesiology Support in Clinical Care

Start date: November 4, 2019
Phase: N/A
Study type: Interventional

Over the past four decades, it has become clear that childhood physical activity carries with it a myriad of beneficial effects. It is closely linked to quality of life and the recognized benefits include, but are not limited to, optimal growth and development, a healthier self-concept, enhanced peer socialization, and decreased anxiety and depression. Long term, an active lifestyle decreases the risk of many important physical and mental morbidities. Thus, the observation that children living with medical conditions and disabilities (MC&D) today, although surviving longer thanks to advances in medical care, are much less active than their peers is a matter of significant concern. Research indicates that the 350,000 Ontario children with MC&D have lower levels of physical activity, higher screen time and more frequent sleep problems. While the reasons underlying this reality are complex, previous research has identified a substantial subset of children who are motivated to be active but lack the confidence to do so. Fear of pain, concern for MC&D exacerbation and a lack of confidence in individual physical movement capacity contribute to their hesitation. Clinical experience suggests that these children represent 50% to 70% of inactive patients. Research indicates that being motivated to make a change and having the confidence that the desired change can be achieved are the essential precursors upon which successful behaviour change initiatives are built. This randomized, controlled trial will explore whether group sessions with a Registered Kinesiologist lead to a direct bolstering of physical activity confidence, and in turn to increased and sustained physical activity in these children. Such an approach holds the promise of a nonpharmacologic, low cost and accessible means of enhancing health that shall be met with a high level of patient and family support while bringing a significant societal and medical return on investment.

NCT ID: NCT04093011 Recruiting - Clinical trials for Congenital Heart Disease

Perioperative Outcome of Congenital Heart Disease Surgery in Childhood

Start date: January 1, 2012
Phase:
Study type: Observational

Congenital heart disease is the most common congenital malformation in the world with high morbidity and mortality. However, there is no data to assess the perioperative outcome of congenital heart disease surgery among Chinese cross-regional population. This study aims to investigate the perioperative outcome of congenital heart disease surgery in childhood from a chinese cross-regional cohort.

NCT ID: NCT04090827 Completed - Clinical trials for Congenital Heart Defect

The Transitioning Rural Adolescents to Adult Care Study

TRAAC
Start date: September 1, 2019
Phase: N/A
Study type: Interventional

Approximately 1 in 10 teenagers lives with a chronic health condition that will require ongoing care as they enter adulthood. Birth defects of the heart, also known as congenital heart disease (CHD) are more common than any other type of birth defect and affect about 1 in 100 children, with most surviving to adulthood. However, most teenagers with CHD have little knowledge about their heart and lack confidence in talking with doctors and nurses about their health. These are essential skills when entering the adult-oriented health care system after graduating from pediatric care. In the current study proposal our team plans to evaluate the effectiveness of delivering 1-on-1 teaching sessions for adolescents who live in smaller communities and can't easily come to Edmonton for appointments in the heart clinic. Fortunately in Alberta we have a widely available system called Telehealth that allows nurses and teens to meet by private, secure teleconferencing while hundreds of miles away. Telehealth is provided by health clinics around the province. We propose to use Telehealth in adolescents' home communities to provide these teaching sessions for 16-19 year olds with CHD who are soon going to be graduating from pediatric to adult care. Participants who receive a nurse-led teaching session will be compared with a similar number of adolescents who are not offered a teaching session, using a questionnaire that addresses skills related to taking care of their health condition. This questionnaire will be completed on-line (or if preferred by the participant, by letter mail) 1 month and 6 month after entering the study. Deciding which adolescents receive a nurse-led teaching session will be random, i.e. like the flip of a coin. Regardless, all participants will receive access to a website for young people with CHD called iHeartChange.

NCT ID: NCT04090697 Terminated - Clinical trials for Congenital Heart Disease

Use of Oxandrolone to Promote Growth in Infants With HLHS

Start date: December 20, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

The primary aim of this study is to determine if clinically relevant doses of buccally administered oxandrolone are safe and tolerable in neonates with hypoplastic left heart syndrome (HLHS) or other single right ventricular anomalies who have undergone a Norwood procedure. The secondary aim is to evaluate the efficacy of buccally administered oxandrolone in improving objective indices of growth and nutrition in neonates who have undergone a Norwood procedure.