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Heart Diseases clinical trials

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NCT ID: NCT05214573 Active, not recruiting - Type 2 Diabetes Clinical Trials

Second-line Therapies for Patients With Type 2 Diabetes and Moderate Cardiovascular Disease Risk

Start date: December 1, 2021
Phase:
Study type: Observational

We will use the target trial framework for causal inference to conduct this observational retrospective cohort study that uses claims data of adults with type 2 diabetes (T2D) included in the de-identified datasets of OptumLabs Data Warehouse (OLDW) and Medicare fee-for-service. In Aim 1, we will emulate a target trial comparing the effectiveness of glucagon-like peptide-1 receptor agonists (GLP-1RA), sodium-glucose cotransporter 2 inhibitors (SGLT2i), dipeptidyl peptidase-4 inhibitors (DPP-4i), and sulfonylureas (SU) in adults with T2D at moderate risk of cardiovascular disease (CVD) with regard to major adverse cardiovascular events (MACE), expanded MACE, microvascular complications, severe hypoglycemia, and other adverse events. In Aim 2, we will compare these four drug classes in the same population of adults with T2D included in OLDW and Medicare fee-for-service data with respect to a set of composite outcomes identified by a group of patients with T2D as being most important to them. Specifically, in Aim 2A, we will prospectively elicit patient preferences toward various treatment outcomes (e.g., hospitalization, kidney disease) using a participatory ranking exercise, then use these rankings to generate individually weighted composite outcomes. Then, in Aim 2B, we will estimate patient-centered treatment effects of four different second-line T2D medications that reflect the patient's value for each outcome. In Aim 3, we will compare different medications within each of the four therapeutic classes with respect to MACE.

NCT ID: NCT05213598 Recruiting - Clinical trials for Congenital Heart Disease

Fontan Associated Liver Disease and the Evaluation of Biomarkers for Disease Severity Assessment

Start date: September 7, 2022
Phase:
Study type: Observational

Background: In Fontan Associated Liver Disease (FALD), congestion of blood in the liver causes cirrhosis. This condition can cause death. Researchers want to understand what triggers this process and find new treatments for it. Objective: To understand how long-term congestion of blood in the liver causes liver scarring that eventually leads to cirrhosis. Eligibility: People aged 18 and older who are at risk of developing FALD from the Fontan procedure. Design: Participants will be screened with: Medical history Physical exam Blood and urine tests Liver ultrasound. This uses sound waves to take pictures of the body. Participants will have an outpatient visit within 12 weeks after screening. Within 24 weeks later, they will have a 3-day hospital stay. About 2 weeks later, they will have a follow-up visit. Visits will include repeats of the screening tests and: Heart tests Stool collection Questionnaires MRI of the liver. Participants will lie on a bed that slides in and out of the scanner. They will receive a contrast agent injected into a vein. While in the scanner, they will also have an MRCP to view the bile ducts and the pancreatic duct. Fibroscan exam. This is an ultrasound that uses a special probe to look at the toughness of the liver. Upper endoscopy. This uses a thin scope to look inside the upper digestive tract. Liver biopsy. This will be taken through large vein in the neck or through the chest. Just before the biopsy, participants will have pressure measurements inside their liver. For this, a catheter will be inserted into a neck vein and guided into the liver.

NCT ID: NCT05211024 Active, not recruiting - Clinical trials for Rheumatic Heart Disease

A Long-term Follow up Study for Patients Who Participated in the GOAL Trial (GOAL-Post)

Start date: January 28, 2022
Phase:
Study type: Observational

GOAL-Post is comprised of two studies that will help refine recommendations for the duration of secondary prophylaxis for children diagnosed with latent RHD, which is currently not known

NCT ID: NCT05208567 Recruiting - Clinical trials for Heart Valve Diseases

London Valvular Heart Disease and Reduced Ejection Fraction Detection in a Multi-ethnic Community Using Cardiac Ultrasound

LOVE
Start date: March 14, 2023
Phase:
Study type: Observational

Heart Valve Disease and Heart failure contribute to 25% of hospital emergency admissions while heart failure alone has become one of the most common causes for hospitalisation in people over the age of 65. The burden of disease is likely to be high in a multi-ethnic community but there is a paucity of data. Management of heart valve disease requires appropriate surveillance and timely surgery. Similarly heart failure management requires treatment with medications aimed at slowing prevention of symptoms and preventing premature death. The NHS long term plan priorities early detection and treatment of valve disease and heart failure in order to reduce the burden on emergency services and improve the health of the population. Diagnosis is made using cardiac ultrasound, however staff with the required skills-set are critically limited in the community. The investigators will train non-expert staff within primary care to perform abbreviated cardiac ultrasound to detect heart valve disease or heart failure. This will be opportunistic scanning to reduce healthcare footfall. All scans will be reviewed by an expert and the investigators will use the anonymised data to develop machine learning tools to begin working with academic partners to develop tools that can improve the reliability of diagnosis from ultrasound. The investigators hope to identify the proportion with the above conditions in a multi-ethnic community and assess the feasibility of developing a program where staff can be trained for community detection, streamlined referrals can be created bridging the gap between primary and secondary care, reducing hospital emergency admissions, while ensuring patients are managed optimally.

NCT ID: NCT05206929 Recruiting - Heart Failure Clinical Trials

Cardiac Surgery Sternal Precautions

Start date: June 1, 2022
Phase: N/A
Study type: Interventional

Our study aims to compare postoperative outcomes, postoperative pain and postoperative quality of lives in patients who receive the standard sternal precautions to those in patients who received self-managed sternal precautions following sternotomy for cardiac surgeries. The purpose of the study is to see if self-managed sternal precautions following sternotomy for cardiac surgeries lead to better quality of lives while maintaining same postoperative pain and rate of postoperative adverse events than standard sternal precautions. Postoperative pain and postoperative quality of lives will be assessed by phone call surveys. Postoperative outcomes will be measured by following the patients for up to a year using electronic medical record.

NCT ID: NCT05203874 Recruiting - Clinical trials for Congenital Heart Disease

Contribution of Multimodal Imaging in Early Coarctation

CT-COARCT-PED
Start date: January 1, 2022
Phase:
Study type: Observational

The CT-Coarct-PED study is a multicentred observational study aiming to describe the population of early coarctation during the last 10 years in South of France. The secondary objective is to assess the importance of cross-sectional imaging in the surgical management of aortic coarctation in the first year of life

NCT ID: NCT05203484 Suspended - Clinical trials for Ventricular Tachycardia

Effect of Multielectrode Versus Point-by-Point Mapping on Recurrence of Ventricular Tachycardia in Ischemic Heart Disease

EMPIRE-VT
Start date: October 1, 2022
Phase: N/A
Study type: Interventional

VT ablation is a frequently performed intervention in patients with symptomatic ventricular tachycardia, electrical storm due to monomorphic VT and appropriate ICD shocks, primarily aiming at reducing the burden of complaints, and ICD shocks. The recommendations for its use were described in the ESC guideline for ventricular arrhythmias and the prevention of sudden cardiac death. To visualize the arrhythmogenic substrate leading to ventricular tachycardia complex mapping techniques are currently used in clinical routine, including conventional Point-by-Point mapping or Multielectrode Mapping. The latter is associated with shorter Mapping and overall procedure times, while maintaining the same primary endpoint of the procedure itself. The aim of this trial is to validate, whether the reduction of mapping and procedure time is associated with a comparable long-term outcome compared with conventional Point-by-Point mapping.

NCT ID: NCT05199857 Recruiting - Frailty Clinical Trials

WE BEAT - HEART Club Fontan Wellness Project: A Virtual Resilience Promotion and Frailty Prevention Program

Start date: March 30, 2022
Phase: N/A
Study type: Interventional

This trial is being conducted to evaluate the effect of a small-group wellness education program combined with a longitudinal, individualized prescription exercise program on the wellness, resiliency, and daily activity levels of pediatric patients with Fontan physiology. There will be two phases for this project. The first phase is the "WE BEAT Group Wellness Education Program" and participants will be transitioned into the phase two HEART Club following phase one. The trial will look at feasibility and acceptability of the program. Additional hypothesis include home whether exercise interventions can: - be delivered without any associated serious cardiac events; - will result in a decreased proportion of patients who are categorized as frail when compared to the cohort's pre-test baseline. - will result in increased measured peak oxygen consumption when compared with their pre-intervention baseline. - will result in increased step counts measured monthly from baseline to end of intervention - will improve self-reported quality of life from baseline to post-intervention. - will result in increased patient reported activity level from baseline to post-intervention

NCT ID: NCT05198583 Recruiting - Clinical trials for Heart Defects, Congenital

EF Intervention in Children With Severe Congenital Heart Disease

E-FIT
Start date: July 1, 2022
Phase: N/A
Study type: Interventional

Survival rates of children with severe congenital heart disease (CHD) have increased with ongoing medical progress over the past decades. However, many children with CHD face academic challenges during adolescence, which are associated with executive dysfunction. Executive functions (EF), higher-order cognitive processes allowing goal-directed behavior, can be particularly affected in children with CHD. To improve EF in affected children, a specific EF intervention has been developed. The intervention lasts a total of 8 weeks and is structured in 3 modules. The first module consists of a weekly strategy training in which problems resulting from executive dysfunction are addressed. Online games form the second module. These are games implemented online to promote EF through play. The third module is also based on games: The families receive several board games to play together at home. This third module is voluntary. This intervention is tested on its feasibility. As the intervention was built in a patient centered manner, we expect it to be feasible, showing in a high adherence rate and satisfaction.

NCT ID: NCT05196659 Recruiting - Heart Failure Clinical Trials

Collaborative Quality Improvement (C-QIP) Study

C-QIP
Start date: September 9, 2022
Phase: N/A
Study type: Interventional

The overarching goal of this study is to develop, implement, and evaluate the effect of a collaborative quality improvement (C-QIP) intervention (consisting of non-physician health workers, text messages for a healthy lifestyle, and a clinical decision support system) on processes of care and clinical outcomes among individuals with previous cardiovascular disease in India.