Sacubitril/Valsartan in Patients With Prosthetic Heart Valves With Heart Failure and Reduced Ejection Fraction
NCT07192341 · Sacubitril/Valsartan, Prosthetic Heart Valve,
Heart Failure RecruitingThis study aims to evaluate the effect of sacubitril/valsartan in patients with prosthetic heart valves with heart failure with reduced ejection fraction (HFrEF).
PhaseNA
TypeInterventional
Age18 Years
WhereKafr ash Shaykh, Kafrelsheikh, Egypt
SponsorKafrelsheikh University
▾Tap for detailsClick for full details — eligibility, all locations, contacts Lifestyle Behaviours of Women Newly Diagnosed With Heart Failure
NCT05416879 ·
Heart Failure RecruitingHeart Failure occurs when the heart's ability to pump blood is reduced. Heart failure can lead to symptoms of breathlessness, fatigue and ankle swelling, and result in health complications including damage to other organs (e.g. kidneys), reduced function and quality of life. Although the symptoms of heart failure are similar for men and women, there are sex differences. Lifestyle behaviours such as physical activity are important modifiable risk factor for heart failure. Women continue to be underrepresented in heart failure studies and treatment guidelines are male-derived due to these disparities in recruitment. The purpose of the present study is to evaluate the physical activity levels, sedentary behaviour, sleep and quality of life and understand the barriers and facilitators to these lifestyle behaviours in women newly diagnosed with heart failure.
Phase—
TypeObservational
Age18 Years
WhereNewcastle upon Tyne, United Kingdom
SponsorNewcastle University
▾Tap for detailsClick for full details — eligibility, all locations, contacts Integration of Telemedicine and Home-Based Cardiac Rehabilitation: Feasibility, Efficacy, and Adherence
NCT05972070 · Myocardial Infarction, Percutaneous Transluminal Coronary Angioplasty, Coronary Artery Bypass
RecruitingThe aim of this study is to evaluate feasibility, efficacy, and adherence of home-based cardiac rehabilitation with the integration of telemedicine. Several components will be assessed such as quality-of-life, nutritional counseling, maximum metabolic activity (MET's), diabetic management, tobacco cessation, lipid, blood pressure, and psychosocial management. These tasks will be accomplished through concurrent conversations between patients and their therapist's utilizing telemedicine with observed exercise training.
Phase—
TypeObservational
Age18 Years
WhereBrookfield, Connecticut, United States
SponsorROM Technologies, INC
▾Tap for detailsClick for full details — eligibility, all locations, contacts Improving TRansitions ANd OutcomeS for Heart FailurE Patients in Home Health CaRe (I-TRANSFER-HF)
NCT06118983 ·
Heart Failure RecruitingThis study is trying to improve the hospital-to-home transition for people with heart failure who receive home care services. The study will test an intervention called I-TRANSFER-HF, which differs from usual care by combining early home health nurse visits and outpatient medical appointments. The study is interested in two questions: 1. Is I-TRANSFER-HF better than usual care at preventing heart failure patients from returning to the hospital within 30 days? 2. Are there parts of I-TRANSFER-HF that are easy or hard to implement in the real world? The researchers will answer these questions by testing the intervention among pairs of hospitals and home health agencies across the country. During the study, the hospital-agency pairs will be asked to implement I-TRANSFER-HF. The researchers will then compare the results from before and after I-TRANSFER-HF was adopted. They will also interview people from these hospitals and agencies to see how I-TRANSFER-HF is being implemented under real-world conditions.
PhaseNA
TypeInterventional
Age18 Years
WhereNew York, New York, United States + 1 more
SponsorWeill Medical College of Cornell University
▾Tap for detailsClick for full details — eligibility, all locations, contacts 30 Days and 90 Days Heart Failure Re-Admission at Komfo Anokye Teaching Hospital
NCT07100561 ·
Heart Failure RecruitingIn Ghana, about 88.3 per cent of cardiac admissions are due to Heart failure, making it the leading cause of admission due to heart conditions. Despite improved knowledge on heart failure and an increasing array of evidence-based guideline treatment options, there is still a significant readmission rate worldwide. This may be due to the underutilization of these evidence-based therapies or a lack of proper follow-up on these patients. Recurrent hospital admission is an independent predictor of death in heart failure. Strategies aimed at providing increased support at discharge and effective follow-up may be associated with lower readmission risk. This study aims to assess the effect of extensive post-discharge counselling and effective phone-based follow-up on the 30-day and 90-day heart failure readmission rate at a tertiary hospital in Ghana. This is a single-centre, pilot randomised controlled trial of heart failure patients admitted to the Komfo Anokye Teaching Hospital
PhaseNA
TypeInterventional
Age18 Years
WhereKumasi, Ashanti Region, Ghana
SponsorKomfo Anokye Teaching Hospital
▾Tap for detailsClick for full details — eligibility, all locations, contacts Left Bundle Branch Area Pacing or Biventricular Pacing in AF and Left Ventricular Dysfunction
NCT06620705 ·
Heart Failure, Block, Heart, Pacing-Induced Cardiomyopathy
RecruitingIt is unknown whether left bundle branch area pacing (LBBAP) or biventricular pacing best prevents or reverses left ventricular (LV) adverse remodelling in patients with atrial fibrillation (AF) who require ventricular pacing or CRT. This randomized non-inferiority cross-over trial will compare left ventricular end-systolic volume change and secondary endpoints between LBBAP and biventricular pacing in patients with AF and LV dysfunction.
PhaseNA
TypeInterventional
Age18 Years
WhereAarhus N, Aarhus N, Denmark + 1 more
Sponsorsrdpiers
▾Tap for detailsClick for full details — eligibility, all locations, contacts Risk Evaluation and Management in Heart Failure
NCT02998788 ·
Heart Failure, Risk Factor, Cardiovascular
RecruitingThis is an prospective study conducted in a Chinese heart failure population. The study investigates the effects of cardiovascular disease risk factors such as lifestyle behaviors,biomarkers and intermediate diseases on heart failure prognosis.
Phase—
TypeObservational
Age18 Years
WhereShanghai, Shanghai Municipality, China
SponsorRuijin Hospital
▾Tap for detailsClick for full details — eligibility, all locations, contacts Nicotinamide Riboside and Prevention of Cancer Therapy Related Cardiac Dysfunction in Breast Cancer Patients
NCT05732051 ·
Breast Cancer,
Metastatic Breast Cancer, Cancer Therapy-Related Cardiac Dysfunction
RecruitingBreast cancer is the most common form of cancer in women. Modern breast cancer treatments have led to increased survival, but at the same time, increased risk for cardiotoxicity and development of heart failure. In this study, the investigators want to evaluate whether nicotinamide riboside can prevent cancer-related cardiac dysfunction in metastatic breast cancer patients scheduled for anthracycline therapy. Further, the investigators will evaluate change in signs of skeletal muscle injury and functional capacity.
PhasePhase 2
TypeInterventional
Age18 Years
WhereLørenskog, Akershus, Norway
SponsorUniversity Hospital, Akershus
▾Tap for detailsClick for full details — eligibility, all locations, contacts Sensor-controlled Digital Game for Heart Failure Self-management: A Clinical Trial
NCT05056129 ·
Heart Failure RecruitingThis study evaluates a sensor-controlled digital game (SCDG) to motivate self-management behaviors of weight monitoring and physical activity in adults with heart failure (HF). Half of the participants will receive the SCDG app and weight monitoring and physical activity sensors and the other half will receive only the weight monitoring and physical activity sensors.
PhaseNA
TypeInterventional
Age45 Years
WhereAustin, Texas, United States
SponsorUniversity of Texas at Austin
▾Tap for detailsClick for full details — eligibility, all locations, contacts Pulmonary Vein Isolation Alone or in Combination With Substrate Modulation After Electric Cardioversion Failure
NCT05264831 · Persistent Atrial Fibrillation
RecruitingThis study aims at assessing whether electric cardioversion can act as a discriminant factor between patients requiring Pulmonary Vein Isolation (PVI) procedure alone or PVI procedure combined with substrate modulation. All included patients will undergo an electric cardioversion, then: * Patients with electric cardioversion success will be treated as per Standard of Care and according to ESC recommendations (2020). A prospective registry will be implemented for these patients. * Patients with electric cardioversion failure will be randomized in the study between 2 ablative procedures: * PVI procedure alone * PVI procedure combined with substrate modulation
PhaseNA
TypeInterventional
Age18 Years – 80 Years
WhereCaluire-et-Cuire, France + 12 more
SponsorElsan
▾Tap for detailsClick for full details — eligibility, all locations, contacts Exploring Water-free Sodium Storage
RecruitingThe overarching goal of this proposal is to definitively establish if acute water free Na storage and release occurs, if the amount stored/released is of a quantity that is physiologically relevant, and if the location is intracellular vs. extracellular.
PhaseNA
TypeInterventional
Age18 Years
WhereNew Haven, Connecticut, United States
SponsorYale University
▾Tap for detailsClick for full details — eligibility, all locations, contacts Conservative Management of Left Ventricular Assist Device Candidates
RecruitingLeft ventricular assist device (LVAD) candidates will be comprehensively evaluated at our center, including clinical evaluation, echocardiography, right heart catheterization, cardiopulmonary exercise test and laboratory exams. following this evaluation, patients will be treated with inotropes, diuretics, uptitrated neurohormonal therapy. vitamin and iron deficiencies will be corrected and the patients will be referred for coronary interventions and cardiac resynchronization therapy appropriately. The need for LVAD implantation will be reevaluated according to the patient's clinical condition, echocardiography and laboratory findings.
Phase—
TypeObservational
Age18 Years – 80 Years
WhereTel Aviv, Israel
SponsorTel-Aviv Sourasky Medical Center
▾Tap for detailsClick for full details — eligibility, all locations, contacts Pharmacological and Mechanical Support Approaches in the Management of Acute Heart Failure in the Regional Network Model for the Management of Cardiogenic Shock
NCT06827314 · Cardiogenic Shock, Acute Coronary Event
RecruitingThe goal of this observational study is to understand and describe the epidemiology of cardiogenic shock in Emilia Romagna with a specific focus on outcome stratified by aetiologies, sex and age. The main outcomes are: * Incidence of cardiogenic shock (CS) over the total CICU admissions, CS-related in-hospital mortality and length of hospitalization, stratified by aetiologies, sex and age * Epidemiology of patients admitted with CS, regarding age, gender, etiology and modality of presentation (acute or acute on chronic), echocardiographic and haemodynamic data, treatment strategy with inotropes and/or short-term MCS, cardiac arrest. This is an observational study without intervention. Patients will be treated according to current clinical practice, according to physician judgment and data sheets of each drug used according to clinical practice.
Phase—
TypeObservational
Age18 Years
WhereBologna, Bologna, Italy
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna
▾Tap for detailsClick for full details — eligibility, all locations, contacts Mechanism of Sarcopenia in Heart Failure
NCT05063955 ·
Heart Failure, Sarcopenia, Cachexia
RecruitingThe aim of the study is to provide information on the interaction between socioeconomic factors, daily physical activity, nutrition and lifestyle on loss of muscle mass and muscle function in patients with heart failure.
Phase—
TypeObservational
Age18 Years – 90 Years
WhereAarhus N, Denmark
SponsorAarhus University Hospital
▾Tap for detailsClick for full details — eligibility, all locations, contacts Determination of the Prevalence of Unrecognized Heart Failure Among Patients at Risk in Urban Areas Across Germany Using CMR
RecruitingHeart failure (HF) in patients at risk is often overlooked, and when detected, there is a lack of early and effective preventive interventions. The WE-CARE-HF-CMR study, conducted in large cities/metropol areas in Germany ( \> 1.000.000 inhabitants), aims to close this gap by evaluating the feasibility of a mobile, telemedicinemonitored HF-screening approach combining cardiac magnetic resonance imaging (CMR), quality of life assessment and laboratory tests as key elements in asymptomatic patients at risk. WE-CARE-HF-CMR will provide a proposal for a comprehensive, contemporary screening approach for patients at risk to develop HF tailored to the needs of the target population. This will provide important new information on the prevalence of asymptomatic HF in at-risk patients in urban versus rural areas. The results of the study will be compared with the results from the "HERZCheck'' trial, which provides data from approximately 4,500 participants in rural areas in Germany and has already been completed (NCT05122793).
Phase—
TypeObservational
Age40 Years – 69 Years
WhereBerlin, Germany
SponsorGerman Heart Institute
▾Tap for detailsClick for full details — eligibility, all locations, contacts Research on Optimal Diagnosis and Treatment of Cardiorenal Syndrome
NCT05397392 ·
Heart Failure, Kidney Diseases, Kidney Injury
RecruitingTo estimate the characteristics, pathogenesis, risk factors and intervention measures for different stages of heart and kidney diseases, and to optimize the curative effects of different treatment schemes
Phase—
TypeObservational
Age18 Years
WhereNanjing, China
SponsorNanjing First Hospital, Nanjing Medical University
▾Tap for detailsClick for full details — eligibility, all locations, contacts CSP Versus BiVP for Heart Failure Patients With RVP Upgraded to Cardiac Resynchronization Therapy
NCT06241651 · Conduction System Pacing, Biventricular Pacing, Cardiac Resynchronization Therapy
RecruitingThe present study is a prospective, multicenter, non-inferiority, randomized controlled trail. It aims to investigate whether the efficacy of conduction system pacing (CSP) is non-inferior to biventricular pacing (BiVP) in patients with heart failure and right ventricular pacing (RVP) requiring upgrading to cardiac resynchronization therapy (CRT).
PhaseNA
TypeInterventional
Age18 Years – 80 Years
WhereNanjing, Jiangsu, China
SponsorThe First Affiliated Hospital with Nanjing Medical University
▾Tap for detailsClick for full details — eligibility, all locations, contacts Venous Ultrasound Guided Organ Decongestion in Patients Hospitalized with Acute Decompensated Heart Failure
NCT06714409 · Cardiorenal Syndrome,
Heart Failure, Acute Kidney Injury
RecruitingThe purpose of this study is to assess the feasibility, safety and effectiveness of VExUS guided organ decongestion compared to standard of care in patients hospitalized with acute decompensated heart failue (ADHF). 180 patients will be randomly assigned to either intervention (VExUS) arm or standard of care (SOC) arm. In the intervention arm, the treatment team will be informed by the study team about the results of the VExUS examination to supplement the clinical decision of proper decongestion treatment, while no information will be provided in the standard of care arm. Study visits are scheduled every second day while hospitalized, end of study is set to day of discharge from the ward. Telephone consultation and review of medical journal scheduled after 6 months to assess exploratory endpoints. The overall rationale of the the study is to investigate if venous organ congestion investigated by VExUS score, is a modifiable risk factor in patients hospitalized with ADHF. And secondary to assess if venous organ decongestion guided by VExUS score may safely be implemented in patients hospitalized with ADHF and result in: * differences in length of hospitalization * changes in biomarkers of cardiac strain * changes in renal function and markers of renal injury * achieved doses of heart failure treatment at discharge * in-hospital complications Safety measures with special attention on symptomatic hypotension, arrhythmias, metabolic alkalosis and electrolyte disturbances will be addressed.
PhaseNA
TypeInterventional
Age18 Years
WhereOslo, Norway
SponsorOslo University Hospital
▾Tap for detailsClick for full details — eligibility, all locations, contacts High-Sensitivity Troponin T Plasma Levels in Patients With Aortic Stenosis (Tyrolean Aortic Stenosis Study-2)
NCT02448485 · Aortic Stenosis,
Heart Failure, Syncope
RecruitingTASS-2 (Tyrolean Aortic Stenosis Study-2) aims to characterize the clinical value of minimally elevated troponin T plasma levels both in patients with asymptomatic and symtomatic aortic stenosis.
Phase—
TypeObservational
AgeAny
WhereInnsbruck, Tyrol, Austria
SponsorMedical University Innsbruck
▾Tap for detailsClick for full details — eligibility, all locations, contacts Evaluation of the BMPR2-Activin Signaling Pathway in Group II Pulmonary Hypertension.
RecruitingPrevious data from our group showed reduced BMPR2 isoform A in pulmonary hypertension associated with left heart disease (PH-LHD) of valvular origin. Focusing on dysregulation of the BMPR2-activin pathway, a key regulator of vascular homeostasis, this project uses a multimodal approach combining molecular biology, advanced cardiac imaging, and histology. Its aim is to determine the role of the BMPR2-activin pathway in the development and regression of PH-LHD. We will conduct a prospective observational study with 1-year follow-up in 150 heart failure patients of different etiologies undergoing hemodynamic assessment. Clinical parameters, biomarkers, molecular profiles, and hemodynamic/echocardiographic variables will be analyzed. A nested substudy in 40 heart transplant candidates will include thoracic CT for vascular morphometric analysis and histological correlation in explanted hearts versus healthy controls. We will also assess reversibility of vascular remodeling one year after transplantation. Results may redefine PH-LHD classification, enable phenotypic precision-medicine models, guide targeted therapies such as activin inhibitors, and refine transplant criteria in combined pulmonary hypertension.
Phase—
TypeObservational
Age18 Years
WhereMadrid, Madrid, Spain
SponsorHospital General Universitario Gregorio Marañon
▾Tap for detailsClick for full details — eligibility, all locations, contacts