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Heart Diseases clinical trials

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NCT ID: NCT06070298 Enrolling by invitation - Clinical trials for Valvular Heart Disease

Can a Smartphone Listen to Your Heart? A Performance Study on Detecting Abnormalities in Your Heart Sounds

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

This observational study aims to assess the performance of the software called ausculto™. ausculto™ is a collection of computer algorithms that intend to analyse heart sounds recorded from the built-in microphone of a smartphone for abnormal sounds. Participants will have their heart sounds recorded during their regular clinic appointment after consenting to participate in this study. Researchers will manually annotate the recorded heart sounds to create a database for use in future training and testing of artificial intelligence (AI) intended for medical uses.

NCT ID: NCT06066970 Recruiting - Clinical trials for Myocardial Infarction

Cardiac Biomarkers for the Quantification of Myocardial Damage After Cardiac Surgery

RORSCHACH
Start date: September 5, 2023
Phase:
Study type: Observational

The aim of the study is to clarify whether the perioperative release of the cardiac biomarkers troponin I, troponin T and CK-MB consistently correlate with visualizable myocardial damage, and to what extent these biomarkers are comparable by means of their kinetics and dynamics. Due to the uncertainty regarding the validity of cardiac biomarkers in the diagnosis of myocardial infarction, the answer to these questions could have a considerable influence on internationally valid guidelines and definitions. International studies, especially in the field of coronary surgery and coronary artery disease treatment refer to these definitions, in particular, the adequate treatment of affected patients is directly dependent on them.

NCT ID: NCT06060171 Recruiting - Clinical trials for Valvular Heart Disease

Pathological Changes in the Cardiovascular System in Valvular Heart Disease

PATH-VHD
Start date: August 1, 2021
Phase:
Study type: Observational

An observational cohort study of patients recruited presenting with valvular heart disease. The specialized investigations will focus on myocardial remodelling and scar formation/regression and extracardiac micro- and macro-vascular sequelae of valvular heart disease (VHD). The aim is to investigate the natural history of VHD and its ensuing cardiac and extracardiac end organ effects, the impact of existing interventions and the long-term outcome. We hope to establish the underlying causative aetiology of known associated conditions (e.g. vascular dementia) and to determine if extracardiac changes may serve as early biomarkers of prognosis in VHD. Participants will attend for two visits at Barts Heart Centre or Chenies Mews Imaging Centre and will undergo a panel of tests including cross-sectional cardiac imaging, point-of-care microvascular assessment and blood tests. Patient outcome will be assessed by data linkage to hospital episode statistic (HES) data and ONS data (via NHS spine). We aim to identify determinants that will help to improve patient selection and timing of valve intervention based on advanced clinical, blood and/or imaging biomarkers.

NCT ID: NCT06059404 Active, not recruiting - Diabetes Mellitus Clinical Trials

Tailoring OT and RD Services for Home-delivered Meal Clients

SixtyPLUS
Start date: September 20, 2023
Phase: Phase 1
Study type: Interventional

This is a single-blinded, four-arm randomized controlled trial that will compare health outcomes of home-delivered meal clients. The purpose of this pilot study is to explore which service model is most effective for improving nutritional status, disease management, fall risk, and adherence to meal recommendations. Participants will be randomized into one of four study arms: In Arm 1: clients will receive home-delivered meals and basic nutrition education and fall prevention education. In Arm 2: clients will receive home-delivered meals plus dietitian services. In Arm 3: clients will receive home-delivered meals plus occupational therapy services. In Arm 4: clients will receive home-delivered meals plus dietitian and occupational therapy services. Outcomes will be assessed at baseline and at 3-month follow-up.

NCT ID: NCT06055556 Suspended - Clinical trials for Congenital Heart Disease

Partial Heart Transplantation

Start date: August 4, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if a partial heart transplantation in patients with congenital heart disease is safe and feasible. Participants will have a partial heart transplant involving surgical replacement of the pulmonary valve with the heart valve and supporting blood vessels from an organ donor. The procedure, tests, medications, and follow-up visits will all be done per standard of care. Medical data will be collected to look at outcomes after surgery.

NCT ID: NCT06054516 Recruiting - Clinical trials for Ischemic Heart Disease

Hyperpolarized MRSI in Ischemic Heart Disease: A Metabolic Investigation of the Heart Muscle

Start date: October 13, 2023
Phase:
Study type: Observational

This study aims to investigate the potential of using hyperpolarized [1-13C]-pyruvate magnetic resonance imaging (MRI) to assess metabolic alterations in patients with ischemic heart disease (IHD). Altered myocardial metabolism is recognized as a crucial factor in heart failure and IHD, and modulating cardiac metabolism offers a new approach to treatment. However, current diagnostic modalities use ionizing radiation and have shown limited prognostic value. Hyperpolarization through dynamic nuclear polarization (DNP) enables highly sensitive in vivo detection of metabolic processes. Hyperpolarized [1-13C]-pyruvate allows visualization of glycolysis-related metabolism, providing insights into the breakdown of glucose and its derivatives. By using this technique, the study aims to differentiate viable from non-viable myocardium in patients with IHD. The objectives include implementing hyperpolarized [1-13C]-pyruvate cardiac MRI to image metabolic flux in the human heart and investigating the potential of this method to distinguish viable from non-viable myocardium in patients with IHD. The study endpoints involve assessing metabolic flux through the pyruvate dehydrogenase complex (PDC) and analyzing ratios of different metabolites, which can indicate the extent of pyruvate oxidation and lactate production. A cross-sectional study design involving patients with CHF and ischemic heart disease will be used. Patients will undergo hyperpolarized [1-13C]-pyruvate MRI, PET imaging, late gadolinium enhancement (LGE) MRI, and cardiac magnetic resonance imaging (CMR). The study will compare [1-13C]-pyruvate MRI findings with PET results, allowing for a correlation between metabolic data and traditional imaging techniques. This innovative approach could provide valuable insights into the metabolic changes associated with ischemic heart disease

NCT ID: NCT06048120 Recruiting - Clinical trials for Pulmonary Hypertension Due to Left Heart Disease

A Study to Learn How Safe the Study Treatment BAY2701250 is, How it Affects the Body and How it Moves Into, Through and Out of the Body in Healthy Male Participants When a Single Amount is Given as an Injection Into the Vein (Intravenous Infusion) or Under the Skin (Subcutaneous Injection)

Start date: September 15, 2023
Phase: Phase 1
Study type: Interventional

Researchers are looking for a better way to treat people who have pulmonary hypertension (PH) due to left heart disease. PH due to left heart disease is a condition of high blood pressure in the vessels of the lungs caused by diseases in the left side of the heart. The study treatment, BAY2701250 is under development and will be tested in humans for the first time in this study. Once it is approved, it may help treat people with PH due to left heart disease. The participants of this study will be healthy and will have no benefit from the administration of BAY2701250. However, the study will provide important information for the design of subsequent studies with BAY2701250 in people with PH due to left heart disease. The participants will be randomly (by chance) assigned to receive either placebo or BAY2701250 as an injection into the vein (intravenous infusion) or under the skin (subcutaneous injection). A placebo is a treatment that looks like a medicine but does not have any medicine in it. The main purpose of this first in human study is to learn how safe is BAY2701250 and to what degree medical problems caused by it can be tolerated by the study participants after they receive a single amount (dose) either as an injection into the vein (intravenous infusion) or under the skin (subcutaneous injection)? To answer this, the researchers will collect the number of study participants with medical problems (also called adverse events) after receiving BAY2701250 until the end of the study. Doctors keep track of all adverse events that happen in studies, even if they do not think they might be related to the study treatment. Further objectives of this study are to learn how does a single dose of BAY2701250 move into, through and out the body of the participants after an intravenous infusion or a subcutaneous injection? To answer this, the researchers will measure: - The (average) total level of BAY2701250 in the blood (also called AUC) - AUC divided by dose (also called AUC/D) - The (average) highest level of BAY2701250 in the blood (also called Cmax) - Cmax divided by dose (Cmax/D) after receiving either an intravenous infusion or subcutaneous injection of BAY2701250. A group of participants will start out by receiving a low dose of BAY2701250. The study doctors will look at the results from these participants and then decide whether to increase the dose of BAY2701250 in the next group of participants. Each participant will be in the study for approximately 9-10 weeks, including a first test (screening) phase, an in-house stay of a maximum of 14 days and a follow-up phase after the end of treatment. One visit to the study site is planned during the screening phase, followed by 6 visits (two of which are optional) after the end of treatment. During the study, the study team will, among other: - take blood and urine samples - do physical examinations - examine heart health using electrocardiogram (ECG) and - check vital signs such as blood pressure, heart rate and body temperature

NCT ID: NCT06045039 Recruiting - Clinical trials for Cardiovascular Diseases

Clinical Efficacy of Stent-balloon-stent (SBS) Technique in the Treatment of Coronary Bifurcation Lesions

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

The treatment of coronary bifurcation lesions continue to remain challenges. Due to the special hemodynamics caused by the special anatomical structure of the coronary bifurcation, it is easy to cause vascular crest displacement and plaque formation. The existing single-stent strategy and double-stent strategy are easy to cause vascular crest offset, stent accumulation, in-stent thrombosis, in-stent restenosis and other poor long-term prognosis. Stent-balloon-stent (Stent-balloon-stent, SBS) technique enables the guide wire to enter the side branch from the mesh at the distal end of the main vascular stent, and the drug balloon is used to dilate the opening of the side branch, so that the opening area of the side branch is more than 5mm².The SBS technique reduces the risk of branch vascular dissection, occlusion, snow shoveling phenomenon, maintain the original state of bifurcated blood vessels to the greatest extent, should have a good impact on the long-term prognosis of patients with coronary bifurcation lesions (CBL). The purpose of this study is to explore the feasibility, safety and effectiveness of SBS technique.

NCT ID: NCT06041685 Recruiting - Clinical trials for Congenital Heart Disease

Effect of Local Warming for Arterial Catheterization in Pediatric Anesthesia

WARM-PA
Start date: September 22, 2023
Phase: N/A
Study type: Interventional

The increase in internal diameter (ID) and cross-sectional area (CSA) may facilitate better arterial catheterization. Since an increase in body temperature can cause peripheral vasodilation, we aimed to determine if local warming of the radial artery (RA) catheterization site could improve the success rate of catheterization in pediatric patients.

NCT ID: NCT06041581 Enrolling by invitation - Stroke Clinical Trials

SHADES Mechanistic Trial

SHADES
Start date: April 25, 2024
Phase: N/A
Study type: Interventional

Cardiovascular disease (CVD) is common, deadly, and costly, and adults with insomnia represent a large group of people at elevated risk of developing CVD in the future. This clinical trial will determine if our updated insomnia treatment, called the SHADES intervention, improves CVD factors thought to explain how insomnia promotes CVD and if these improvements are due to positive changes in sleep factors. A total of 200 primary care patients with insomnia and CVD risk factors will be randomized to 6 months of the SHADES intervention (internet, telephonic, and/or face-to-face cognitive-behavioral therapy for insomnia) or the active control condition (sleep education/hygiene, symptom monitoring, and primary care for insomnia). Before and after treatment, participants will complete measurements of the CVD factors (systemic inflammation, autonomic dysfunction, metabolic dysregulation, proinflammatory gene expression) and the sleep factors (insomnia symptoms, sleep onset latency, wake after sleep onset, sleep efficiency). Researchers will test whether the SHADES intervention produces greater improvements in the CVD factors than the active control condition.