This prospective, multicenter, cluster-randomized controlled study aims to evaluate the accuracy of an investigational artificial intelligence (AI) Software as a Medical Device (SaMD) designed to compute ejection fraction (EF) severity categories based on the America...
We've found 25 total result s for "Heart Failure".
The availability of Sodium-glucose cotransporter-2 inhibitors (SGLT2-i) has dramatically altered the management of heart failure (HF) patients, independently of their ejection fraction and glycemic status. A meta-analysis of 57 studies comparing SGLT2-I monotherapy v...
Age: 18 years - 66+
Gender: All
Study Design: This is an international, multicenter, observational, non-interventional, prospective, blinded, single-arm, two-period study, to collect patient utterances that will be retrospectively analyzed to determine the sensitivity and UPNR of the HearO system...
Age: 22 years - 66+
Gender: All
TIER-PC is an adaptive model of delivering palliative care that provides the right level of care to the right patients at the right time. It represents an adaption of the Mount Sinai PALLIATIVE CARE AT HOME (PC@H) program, which delivers home-based palliative care. T...
Age: 18 years - 66+
Gender: All
This is a prospective, multi-center, open label, randomized control clinical trial evaluating the safety and efficacy of the Cordella™ Pulmonary Artery Sensor System in NYHA Class II-III Heart Failure Patients (PROACTIVE-HF-2 Trial). The study contains of 5 arms: ...
Age: 18 years - 66+
Gender: All
Aortix is a circulatory support device for chronic heart failure patients on medical management who have been hospitalized for acute decompensated heart failure (ADHF) and have persistent congestion despite usual medical therapy. Eligible ADHF patients with diureti...
Age: 21 years - 66+
Gender: All
The clinical benefits of the dual Sodium-Glucose cotransporter (SGLT) 1 and 2-inhibition have recently been reported in two clinical trials. The SOLOIST reported the benefits of sotagliflozin in Type-2 Diabetes Mellitus (T2DM) patients hospitalized for worsening of H...
Age: 18 years - 66+
Gender: All
The REVERSE-HF study is a randomized controlled trial to evaluate clinical outcomes of adjustable ultrafiltration with the Aquadex System as compared to adjustable IV loop diuretics in patients with worsening heart failure (HF) and fluid overload.
Age: 18 years - 66+
Gender: All
The overall hypothesis is that treatment with the SGLT2 inhibitor Ertugliflozin induces a differential regulation in interstitial fluid vs plasma volume, with more reduction of the volume from the interstitial fluid than from the circulating plasma volume, which results...
Age: 18 years - 66+
Gender: All
Leveraging a natural experiment approach, the investigators will examine rapidly changing telemedicine and in-person models of care during and after the COVID-19 crisis to determine whether certain patients could safely choose to continue telemedicine or telemedic...
Age: 19 years - 66+
Gender: All
Prospective, randomized, open-label, international, multi-center clinical study to evaluate the safety and efficacy of the AccuCinch Ventricular Restoration System in patients with heart failure and reduced ejection fraction (HFrEF).
Age: 18 years - 66+
Gender: All
Background: Fluid overload, especially pulmonary congestion, is one of the main contributors into heart failure (HF) readmission risk and it is a clinical challenge for clinicians. The Remote dielectric sensing (ReDS) system is a novel electromagnetic energy-based techn...
Age: 18 years - 66+
Gender: All
The OPTIMIZER Smart Post-Approval Study is a prospective, multi-center, non-randomized, single arm open label study of 620 subjects receiving an OPTIMIZER implant as standard of care. Patients to be included will have NYHA functional class III symptoms and a left ventri...
Age: 18 years - 66+
Gender: All
The OPTIMIZER Smart Post-Approval Study is a prospective, multi-center, non-randomized, single arm open label study of 620 subjects receiving an OPTIMIZER implant as standard of care. Patients to be included will have NYHA functional class III symptoms and a left ven...
Age: 18 years - 66+
Gender: All
Chronic heart failure (HF) is a progressive syndrome characterized by the inability of the heart to provide adequate blood supply to meet the metabolic demand of different tissues or to be able to do so only at the expense of elevated left ventricle filling pressure. HF...
Age: 18 - 45 years
Gender: All
The study is designed to determine whether dapagliflozin is superior to placebo, when added to standard of care, in reducing the composite of CV death and HF events (hospitalisation for HF or urgent HF visit) in patients with HF and preserved systolic function. This is ...
Age: 18 - 85 years
Gender: All
An approximately 6000-patient, randomized, unblinded, two-arm, multicenter clinical trial comparing torsemide with furosemide among patients hospitalized for heart failure. 1:1 randomization to either oral torsemide OR oral furosemide (dosing at discretion of local pr...
Age: 18 - 85 years
Gender: All
Sotagliflozin (Sanofi code SAR439954, Lexicon code LX4211) is an orally administered small molecule, the first dual inhibitor of sodium-glucose co-transporter 1 and 2 (SGLT1 and SGLT2), formulated as 75 mg and 200 mg coated tablets. The compound, a member of the pharmac...
Age: 18 - 85 years
Gender: All
This is a double-blind, multicenter, prospective, randomized, placebo-controlled study to assess the effects of IV FCM compared to placebo on the 12-month rate of death, hospitalization for worsening heart failure, and the 6-month change in 6 minute walk test (6MWT) for...
Age: 18 - 85 years
Gender: All
This is a prospective cohort study of 1500 chronic HF patients that will also examine and describe retrospective electronic health record data. We will use the PCORnet (Patient Centered Outcomes Research Network, see "data sources" below) infrastructure to (1) identify ...
Age: 18 - 45 years
Gender: All