HeartLogic France Study: Heart Failure Patients Managed With the HeartLogic Algorithm
Heart FailureHeart Failure (HF) is a chronic disease that leads to numerous rehospitalisations and affects more than one million people in France. The main objective of this prospective multicentric French study is to describe the annual rate of unplanned hospitalisations for heart failure in a cohort of patients managed by a HeartLogic algorithm. Patients will be included if they fulfill the following requirements 1/Patient implanted with a cardiac defibrillator with or without resynchronisation with the HeartLogic index (RESONATE family, Boston Scientific); 2/History of heart failure (left ventricular ejection fraction ≤40 %; or at least one episode of clinical heart failure with elevated NT pro BNP≥450 ng/L). If a HeartLogic index ≥16 is noticed, the investigator will contact the patient to assess the patient's clinical condition and possibly adjust the heart failure treatment.
Cardiopulmonary Stress Testing (CPET) AlloSure Study
Heart FailureTransplant; Failure1 moreCell-free DNA does not vary significantly as a function of the activity of immunologically quiescent cardiac transplant recipients, despite the metabolic demands of the transplanted organ. (The implication of the null result would be that no restrictions to patient activity, nor modification of cardiac rehabilitation prescription, would be necessary to maintain proper test characteristics of AlloSure testing). In immunologically active cardiac transplant allografts, exercise prior to assay of donor-derived cell-free DNA can be used to increase the sensitivity of the AlloSure test. (The implication of this would be that the optimal time-frame for drawing an Allosure may actually be post-exercise, and that window will be characterized).
Effect of Xenon on Brain Injury After Aneurysmal Subarachnoid Hemorrhage
Subarachnoid HemorrhageAneurysmal5 moreAn investigator-initiated clinical drug study Main Objective: To explore neuroprotective properties of xenon in patients after aneurysmal subarachnoid hemorrhage (SAH). Primary endpoint: Global fractional anisotropy of white matter of diffusion tensor imaging (DTI). Hypothesis: White matter damage is less severe in xenon treated patients, i.e. global fractional anisotropy is significantly higher in the xenon group than in the control group as assessed with the 1st magnetic resonance imaging (MRI). After confirmation of aSAH and obtaining a signed assent subjects will be randomized to the following groups: Control group: Standard of Care (SOC) group: Air/oxygen and Normothermia 36.5-37.5°C; Xenon group: Normothermia 36.5-37.5°C +Xenon inhalation in air/oxygen for 24 hours. Brain magnetic resonance imaging techniques will be undertaken to evaluate the effects of the intervention on white and grey matter damage and neuronal loss. Neurological outcome will be evaluated at 3, 12 and 24 months after onset of aSAH symptoms Investigational drug/treatment, dose and mode of administration: 50±2 % end tidal concentration of inhaled xenon in oxygen/air. Comparative drug(s)/placebo/treatment, dose and mode of administration: Standard of care treatment according to local and international consensus reports. Duration of treatment: 24 hours Assessments: Baseline data Information that characterizes the participant's condition prior to initiation of experimental treatment is obtained as soon as is clinically reasonable. These include participant demographics, medical history, vital signs, oxygen saturation, and concentration of oxygen administered. Acute data The collected information will contain quantitative and qualitative data of aSAH patients, as recommended by recent recommendations of the working group on subject characteristics, and including all relevant Common Data Elements (CDE) can be applied. Specific definitions, measurements tools, and references regarding each SAH CDE can be found on the weblink here: https://www.commondataelements.ninds.nih.gov/SAH.aspx#tab=Data_Standards.
Systematic Escalation of diuREtics With Natriuresis in Heart Failure Patients: SERENA Trial
Heart FailureThe present is a multicenter, prospective, randomized, open-label, blinded end-point trial aiming to investigate the clinical benefit of a stepwise, natriuresis-driven diuretic strategy versus standard diuretic treatment in patients with acute decompensated heart failure with reduced ejection fraction (HFrEF) and low early urinary sodium excretion. The study will focus on patients at increased risk of resistance to diuretic therapy. In particular, patients admitted to the emergency department and cardiac intensive care unit due to an on-chronic or de-novo acute decompensated HF episode with a predominantly "wet" profile and low early spot urinary sodium (UNa+) excretion will be considered. Spot natriuresis is a low-cost, non-demanding laboratory test in use to identify diuretic-resistant patients with an inherent poor prognosis. Whether the early identification of diuretic resistant patients and the consequent more aggressive treatment may lead to a better outcome has not been demonstrated by randomized studies. This trial aims to assess if an intensive stepwise diuretic approach guided by systematic urinary output assessment including natriuresis evaluation versus a standard diuretic strategy based on urinary output alone effectively leads to faster euvolemia achievement and better prognosis in a real-world setting.
Blender Biomarkers: A BLENDER Sub-study to Evaluate the Effect of Oxygen Dose on Oxidative Stress...
Cardiac FailureCritical IllnessTo compare the impact of liberal vs conservative oxygen doses on markers of oxidative stress in patients enrolled in the BLENDER trial.
ALP-1 Continuous Intravenous Infusion to Maintain Clinical Stability in Advanced Heart Failure
Heart FailureThis is a global multicenter, doubleblind, placebo-controlled, randomized, parallel-group study that compares ALP-1 given in a continuous infusion and placebo in patients with advanced HF. The difference between the two groups for the primary endpoint will be compared after 6 months of study drug therapy (Double-Blind Treatment Phase).
Heart Failure in Southern Sweden
Heart Failure,CongestiveDrug Use1 moreThe aim of the study is to optimize diagnosis and treatment for patients with heart failure in Swedish primary care. Patient with the diagnose heart failure registered in the electronic medical record (EMR) at seventeen primary health care centers (PHCCs) will be invited to to participate in the study. Blood testing and electrocardiography will be performed. Data on diagnosis and medical treatment will be collected from the EMR. An educational visit with a cardiologist will be performed at the PHCC, in order to discuss evidence-based diagnoses and treatment of heart failure. Data on drug therapy and health care consumption will be collected after six and twelve months.
Real-World Experience - Barostim™ Advancing the Level of Clinical Evidence (REBALANCE Registry)...
Heart FailureThe purpose of this registry is to develop valid scientific evidence of the safety and benefit of Barostim Therapy in the commercial setting in patients with heart failure with reduced ejection fraction (HFrEF) that were recently implanted with the Barostim System.
Multimodality Imaging in the Screening, Diagnosis and Risk StratifictiON of HFpEF
Heart FailureDiastolicThe incidence of Heart failure with preserved ejection fraction (HFpEF) in Heart failure patients increases rapidly. However, the current clinical awareness is insufficient, and the cardiac structural and functional injury are not well understood. It is difficult to recognize the subclinical changes of the cardiac in the early stage with conventional imaging techniques, and it is common to ignore the existence of the clinical alterations. This study aimed to investigate the cardiac features, early diagnosis and risk factors of HFpEF patients, based on the multi-modal (Magnetic resonance imaging- nuclear medicine imaging- echocardiography) imaging, combined with large data and artificial intelligence. This study will provide deep insights into the HFpEF derived from different causes.
Exercise Training to Improve Cardiopulmonary Hemodynamics in Heart Failure Patients
Heart FailurePulmonary HypertensionThis research study is being done to find out if exercise therapy can help improve the heart function, overall health, and quality of life of patients with pulmonary hypertension caused by heart failure.