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Heart Failure clinical trials

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NCT ID: NCT05983341 Active, not recruiting - Heart Failure Clinical Trials

Complications in Pediatric Mechanical Circulatory Assistance: Evaluation of Infection Management.

VADINFECT
Start date: July 1, 2023
Phase:
Study type: Observational

End-stage heart failure in children is a rare cause of infant mortality. The most frequent cause is dilated cardiomyopathy, often of undetermined origin, which can lead to cardiogenic shock refractory to standard medical treatment. In such cases, it is essential to resort to exceptional means, available at tertiary care hospitals such as in Lyon. The therapeutic means includes long-term circulatory assistance (VAD). This type of circulatory assistance is becoming increasingly used in view of the shortage of heart transplants. Indeed, the average waiting time on the paediatric transplant list varies from 3 months to over a year for children under 5. Berlin Heart EXCOR (BHE) is the only long-term support available for children (2). It is a pulsatile para-corporeal assisting device with percutaneous cannulas. Despite technical and medical advances in circulatory support, the presence of foreign material is frequently complicated by infection. Infection is a major cause of morbidity and mortality in this population. It is most often of nosocomial origin, linked to central line infections. The germs associated with these infections are mainly bacteria, with a small proportion of fungi. The most common pathogens are multi-resistant gram-positive bacteria, which colonize the skin, adhere to the implanted equipment and create biofilms. Infections have a major impact on the morbidity and mortality of patients undergoing mechanical assistance, with an increased risk of thrombo-embolic events and difficulty in managing anticoagulation, secondary to inflammation.

NCT ID: NCT05980585 Active, not recruiting - Heart Failure Clinical Trials

Assessment of Heart Failure (HF) At-Home Management Solution ADI Cardio Pulmonary Monitoring System (CPM)

Start date: April 20, 2022
Phase: N/A
Study type: Interventional

This study is meant primarily to assess the deployment of the ADI CPM System in a clinical setting and determine interoperability of the CPM System within existing care pathways for patients with CHF. In this initial study the CPM System will not be used to determine or support clinical decision making however post deployment the clinical study team will review patient HF events and changes in treatment during the course of the deployment and compare to the data generated by the CPM System during the study to determine the accuracy of the patient generated data as a basis for designing a more comprehensive "interventional study" to determine clinical and financial efficacy of the CPM System.

NCT ID: NCT05974189 Active, not recruiting - Clinical trials for Chronic Heart Failure With Reduced Ejection Fraction

The VERIFY Study: An Observational Study Called VERIFY to Learn More About the Use of Vericiguat in People With Chronic Heart Failure With Reduced Ejection Fraction

Start date: July 11, 2023
Phase:
Study type: Observational

This is an observational study in which the health data of people with chronic heart failure with reduced ejection fraction (HFrEF) are collected using administrative claims data. In observational studies, only observations are made and participants do not receive any advice or changes to healthcare. Chronic HFrEF is a longterm condition that occurs when the heart is weak and cannot pump enough blood to the rest of the body with each heartbeat. This leads to a reduced supply of oxygen which the body requires to function properly. The common symptoms include breathlessness, weakness, fatigue, and swelling in the ankles and legs. If left untreated, heart failure can lead to other serious health problems, including damage to other organs, which may result in hospital stays and even death. Vericiguat works by increasing the activity of an enzyme called soluble guanylate cyclase (sGC), which relaxes the blood vessels and allows more blood to flow through. As a result, the heart is able to pump better. Vericiguat was approved for the treatment of HFrEF based on the results of a study called VICTORIA. The VICTORIA study showed that vericiguat helps in lowering the chances of death or hospitalization due to heart failure. There is limited information available about the use of vericiguat for the treatment of HFrEF under realworld conditions. The main purpose of this study is to collect information about the characteristics of people with HFrEF, who are on vericiguat in addition to at least one standard treatment. Researchers will collect information about participants' basic characteristics, including their age, gender, other health conditions they may have, and the medicines they may be taking. The data will come from administrative claims data for people in the United States of America who were diagnosed with HFrEF between January 2020 and June 2022. In this study, only available data from routine care is collected. No visits or tests are required as part of this study.

NCT ID: NCT05948241 Active, not recruiting - Depression Clinical Trials

Online Psychological Support Group for Patients With Heart Failure and Depression

Start date: May 5, 2022
Phase: N/A
Study type: Interventional

Heart failure is a chronic disease, being the second cause of death in Brazil. Currently, it is estimated that 6.4 million Brazilians suffer from this disease. The higher number of rehospitalization, lower survival of these individuals. There are recommendations from Societies of Cardiology for the inclusion of effective self-care for patients with chronic HF, intend greater control of symptoms, greater adherence to treatment and, consequently, decrease of rehospitalization. One of the pillars of self-care's education for chronic patients recommended by the Health Ministry is the management of the patient's emotional aspects. These have been undertreated in most studies. The prevalence of depression among patients with HF is high and ranges from 41% to 72%, and the assessment with the BDI-II, which is the gold standard used, is 67%. Patients with HF and depression have greater difficulty in adhering to treatment and poor maintenance of self-care. Also, they present 4 times more risk of rehospitalization/mortality. Faced with this problem, this project was designed, proposing an online psychological support group for patients with heart failure and depression, primarily aimed at improving self-care, adherence and secondarily at reducing the rates of depression and readmission.

NCT ID: NCT05913778 Active, not recruiting - Clinical trials for Coronary Artery Disease

Long-tErm Effects of Enhanced eXternal CountErpuLsation

EXCEL
Start date: December 10, 2020
Phase: N/A
Study type: Interventional

Enhanced external counterpulsation (EECP) is an effective non-invasive treatment in patients with coronary artery disease (CAD) which complicated by chronic heart failure (CHF). Aim: to study the long-term effects of treatment with enhanced external counterpulsation on the structural and functional state of the vascular bed in patients with stable CAD complicated by CHF. Patients (n=100) with verified stable CAD (class 2-3 angina) complicated by CHF (NYHA class 2-3) and receiving optimal drug therapy included in open randomized study. Primary randomization (2:1) + secondary randomization (1:1). - SHAM-counterpulsation group (ECP-SHAM; compression pressure 80 mm Hg; 35 procedures, 1 hour each); - Active counterpulsation group (ECP35; compression pressure 220-280 mm Hg; 35 procedures, 1 hour each) 1 course per year; - Active counterpulsation group (ECP70; compression pressure 220-280 mm Hg; 35 procedures, 1 hour each) 2 courses per year. Duration of observation is 3 years. Stages of examination: after 3, 6, 12, 24, 36 months (after 3, 6, 12 months for the ECP-SHAM group). Primary endpoint: combination of vascular event (myocardial infarction, acute cerebrovascular accident, revascularization procedures), hospitalization (for CAD/CHF), death. Secondary endpoints: changes in exercise tolerance, a needing for antianginal therapy, frequency of angina episodes. Objectives: to study the dynamics of the structural and functional state of the vascular bed (applanation tonometry, photoplethysmography, computer nailfold videocapillaroscopy), the dynamics of the clinical status (Clinical Status Assessment Scale), the dynamics of exercise tolerance (6-minute walk test), the dynamics of the quality of life of patients ( questionnaires SF36 and MLHFQ) in the ECP35 and ECP70 groups at baseline, at the end of the first course, after 6 months, 1, 2, and 3 years, and in the ECPSHAM group at baseline, at the end of the first course, after 6 and 12 months; (2) To investigate the impact of EECP on the incidence of primary (vascular events, hospitalizations for CAD/CHF, death) and secondary (frequency of angina episodes, need for antianginal drugs, exercise tolerance) endpoints. Expected outcome of the study: Obtaining reliable data on the long-term positive effect of EECP on the dynamics of the structural and functional state of the vascular bed, exercise tolerance, quality of life and prognosis in patients with stable CAD complicated by CHF.

NCT ID: NCT05896904 Active, not recruiting - Heart Failure Clinical Trials

Clinical Comparison of Patients With Transthyretin Cardiac Amyloidosis and Patients With Heart Failure With Reduced Ejection Fraction

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

Clinical comparison of patients with transthyretin cardiac amyloidosis and patients with heart failure with reduced ejection fraction

NCT ID: NCT05887323 Active, not recruiting - Heart Failure Clinical Trials

LBBAP Data Collection Registry

Start date: April 25, 2023
Phase:
Study type: Observational

The purpose of this registry is to evaluate the safety and effectiveness of LBBA pacing/sensing in patients already implanted with the Tendril STS 2088 lead.

NCT ID: NCT05848960 Active, not recruiting - Sarcopenia Clinical Trials

Mediterranean Diet and Nutritional Support in Heart Failure Sarcopenia

Start date: July 1, 2021
Phase: N/A
Study type: Interventional

Heart failure (HF) is a chronic disease with an increasing incidence; it represents the final stage of multiple cardiac diseases and significantly affects the QoL of the patients. Its prevalence is about 26 million people in the world, especially in elderly. Sarcopenia has been directly associated with the presence of increased comorbidity in patients with HF. In this study the investigators aim to compare the clinical evolution of patients with HF after receiving nutritional support with Mediterranean diet alone or in combination with a hypercaloric, hyperproteic oral nutritional Supplement

NCT ID: NCT05839028 Active, not recruiting - Clinical trials for Heart Failure With Preserved Ejection Fraction

Mechanisms of LV Remodeling in Hypertensive Patients Working on a Rotational Expeditionary Basis in the Arctic

Start date: October 16, 2022
Phase:
Study type: Observational [Patient Registry]

The main goal of our investigation is to study the mechanisms of formation of left ventricular remodeling in patients with hypertension, working on a rotational expedition basis in the Arctic.

NCT ID: NCT05820295 Active, not recruiting - Stroke Clinical Trials

Improving How Older Adults at Risk for Cardiovascular Outcomes Are Selected for Care Coordination

Start date: May 17, 2023
Phase: N/A
Study type: Interventional

This pragmatic clinical trial embedded in an accountable care organization will determine the comparative effectiveness of two approaches for assigning care coordinators to older adults at risk for cardiovascular outcomes. The hypothesis is that assigning care coordinators to older adults based on perceived need will be more effective at preventing emergency department visits and hospitalizations compared to usual care.