Clinical Research Directory

Urine Sodium-Driven Diuretic Adjustment Strategy in Acute Decompensated Heart Failure

The goal of this clinical trial is to learn if increasing the dose of diuretics to achieve a higher urine sodium target produces better clinical results when treating patients hospitalized with acute heart failure when compared to lower urine sodium target and standard of care. The main questions it aims to answer are: 1. Does targeting a higher urine sodium goal achieve greater natriuresis and diuresis? 2. Does targeting a higher urine sodium goal reduce frequency of hospital readmissions? 3. Does targeting a higher urine sodium goal reduce hospital length of stay? Researchers will compare natriuresis-guided arms with standard of care to see if targeting higher natriuresis goals improves significantly over current practice. Participants will submit urine samples at routine intervals after being given diuretics to evaluate urine sodium concentration. If urine sodium is low then diuretic dose will be increased.

Multimodal Phenotyping In Patients Referred With Acute Cardiac faiLurE

The goal of this observational study is to learn whether information collected during routine hospital care, together with blood and urine samples, can help doctors better identify different types of cardiogenic shock and better predict outcomes in adults hospitalized with acute heart failure and cardiogenic shock. The main question is whether clinical findings, imaging results, and biomarkers, including sex-specific factors, are associated with the risk of death within 30 days. Participants will not receive an experimental treatment. Researchers will collect data from routine care, collect additional blood and urine samples for biobanking, and follow participants after hospital discharge

Pulmonary Embolism in Patients With Acute Heart Failure (PEHF Study)

This study focuses on two serious and common medical conditions: heart failure and pulmonary embolism (a blood clot in the lungs). Heart failure happens when the heart cannot pump blood effectively, and it is one of the main reasons older adults are admitted to the hospital. Pulmonary embolism can be life-threatening and may worsen heart failure or even trigger it. Doctors believe that pulmonary embolism may often go undetected in patients who come to the hospital with symptoms of acute heart failure, such as sudden shortness of breath. This is because both conditions can cause similar symptoms, making it difficult to tell them apart. As a result, doctors may sometimes assume the symptoms are only due to heart failure and not investigate further for a possible blood clot. However, missing a pulmonary embolism can have serious consequences. Studies suggest that some patients with heart failure who die may actually have had an undiagnosed pulmonary embolism. Current medical guidelines recommend checking for pulmonary embolism when the cause of breathing problems is unclear, but in real-life practice, this is not always done. The goal of this study is to find out whether pulmonary embolism is underdiagnosed in patients with suspected acute heart failure and whether systematically testing for it could improve patient outcomes. To do this, the study will compare two approaches in several hospitals. In half of the hospitals, doctors will follow their usual practice and decide case by case whether to test for pulmonary embolism. In the other half, doctors will systematically test all eligible patients for pulmonary embolism using recommended diagnostic methods. Adult patients admitted with recent or worsening breathing difficulties and signs of acute heart failure may be included in the study, provided they give their consent. Researchers will collect information about their symptoms, tests, diagnosis, and treatments. Patients will be monitored during their hospital stay and for three months afterward. The study will track important outcomes such as survival, new blood clots, bleeding events, repeated hospital visits for breathing problems, and overall time spent in the hospital. The researchers expect to include about 740 patients in total. They estimate that pulmonary embolism may be found in about 1% of patients with usual care, but up to 5% when doctors systematically look for it. This study aims to better understand how often pulmonary embolism occurs in patients with acute heart failure and whether more systematic testing could lead to earlier diagnosis and better care. The results could help improve medical practice and reduce complications or deaths related to missed diagnoses.

ReDS-guided Decongestion Strategy in Patients Hospitalized for Heart Failure

This clinical trial aims to determine whether a ReDS-guided treatment strategy is superior to the current standard of care for adults hospitalized with heart failure. Additionally, the study will evaluate the safety and cost-effectiveness of this approach. The study seeks to answer the following key questions: 1. Does the ReDS-guided strategy reduce the risk of cardiovascular events during the first month following hospital discharge? 2. What is the safety profile of this treatment strategy? Researchers will compare the ReDS-based strategy against the current standard of care. All participants will: * Undergo daily assessments using the ReDS device throughout their hospitalization. * Attend two follow-up visits post-discharge, scheduled at 2 weeks and 30 days.

POcus INTERvention for Tailoring Diuretic Strategy in Acute Decompensated Heart Failure

Acute decompensated heart failure (ADHF) is a frequent cause of hospitalization and is associated with high morbidity and mortality. Congestion is the primary pathophysiological mechanism leading to clinical deterioration and hospitalization in ADHF. Diuretics remain the cornerstone of treatment for most ADHF phenotypes; however, evidence regarding optimal strategies to guide diuretic therapy during the decongestion process is limited. Recently, point-of-care ultrasound (POCUS) has emerged as a promising tool to support clinical assessment in ADHF, improving diagnostic accuracy, prognostication, and pre-discharge evaluation. Nevertheless, the role of POCUS in guiding therapeutic management in ADHF remains uncertain. To specifically assess congestion in patients with ADHF, a pragmatic POCUS-based score, the Dynamic Ultrasound Congestion Score (DUCS), was developed. DUCS integrates lung ultrasound and Venous Excess Ultrasound (VExUS) to dynamically evaluate congestion severity, treatment response, and therapeutic goals during ADHF management. Observational data suggest that DUCS is associated with in-hospital outcomes and short-term prognosis, and correlates with markers of decongestion such as urinary output and weight loss. This study is a randomized, single-center, single-blind clinical trial designed to evaluate whether a DUCS-guided POCUS strategy improves clinical and decongestion outcomes compared with standard of care. Eligible patients hospitalized due to ADHF will be randomized within 48 hours of admission to one of two groups: (1) diuretic treatment guided by institutional standard-of-care combined with information from the EVEREST congestion score assessment and guideline-based treatment recommendations; or (2) diuretic treatment guided by serial DUCS-based POCUS assessments used to inform diuretic adjustment recommendations. Participants in both groups will undergo evaluations at baseline (day 1), day 2, day 3 and day 5, including clinical data collection, physical examination using the EVEREST congestion score, and standardized DUCS-based POCUS assessments. Outcomes to be assessed include in-hospital mortality, length of hospital stay, decongestion parameters, and changes in biomarkers.

Evaluation of Fibroscan® Performance in Diagnosing Acute Heart Failure in Patients Presenting to the Emergency Department

Acute heart failure (AHF) is a major cause of acute dyspnea in emergency departments (EDs), driven primarily by venous congestion, which can lead to hepatic congestion and risk of subsequent liver dysfunction. Current diagnostic tools include clinical evaluation, biomarkers, and imaging (Chest X-Ray or echography), are often limited by delayed results, variability, and suboptimal accuracy in emergency settings. Fibroscan®, a non-invasive device originally designed to assess liver stiffness in chronic liver conditions, has shown potential in detecting liver congestion linked to heart failure. Studies have highlighted significant correlations between liver stiffness measurements (LSM) and markers of venous congestion, such as central venous pressure and adverse outcomes in heart failure patients. Preliminary findings suggest that LSM could provide rapid, bedside insights into systemic congestion, offering a promising avenue for improving diagnostic workflows in acute care. While prior research has mainly focused on chronic heart failure or small study populations, further investigation is needed to explore the utility of Fibroscan® in acute presentations of AHF within EDs. This could help address the limitations of existing diagnostic approaches and enhance patient management in time-sensitive environments.

Restrictive Versus Liberal Fluid Intake in Acute Decompensated Heart Failure

The aim of this clinical trial is to learn whether a thirst-driven, liberal fluid-intake strategy is comparable to a fluid-restriction strategy in patients hospitalized for acute decompensated heart failure (ADHF). The study will also assess the safety of the intervention and its effects on thirst and quality of life. Patients hospitalized with ADHF will be asked to follow either a thirst-driven fluid-intake strategy or a fluid-restriction strategy during their hospital stay and for one month after discharge.

Early Gliflozin for Elderly Patients With Acute Decompensated Heart Failure in the Emergency Department

Background: SGLT2 inhibitors reduce CHF morbidity/mortality but are underutilized in elderly patients with acute decompensated CHF (ADCHF) admitted outside cardiology departments. Objective: Assess feasibility of early ED-initiated gliflozin therapy in elderly ADCHF patients. Design: Multicenter, randomized, open-label pilot study; N=144 patients (72 per arm) across 6 EDs over 30 months. Population: Age ≥75 years, ED admission for ADCHF (symptomatic worsening, congestion, elevated natriuretic peptides), gliflozin-naïve, requiring hospitalization. Key Exclusions: Type 1 diabetes, eGFR \<25 mL/min/1.73m², cardiogenic shock, recent ACS, cardiology ward admission. Intervention: Treatment: Dapagliflozin 10mg daily within 24h + cardiac nurse telephone follow-up at 1 month Control: Standard care only Primary Outcome: Feasibility (organizational implementation, acceptability, protocol adherence, timeline compliance). Follow-up: 7-day visit (clinical assessment, NT-proBNP, echocardiography) and 3-month cardiology consultation (mortality, rehospitalization, QoL, biomarkers, safety parameters).

Digoxin After Acute Heart Failure

The DIG-DICA trial is a randomized, controlled, open-label, single-center study designed to evaluate whether adding low-dose digoxin to optimal medical therapy after an episode of acute decompensated heart failure improves patients' clinical status and quality of life. The study enrolls adults with heart failure with reduced ejection fraction (HFrEF) who have recently stabilized after hospitalization or urgent care for decompensation. The primary aim is to determine whether digoxin increases the proportion of patients who are "Alive and Well" at 180 days-defined by achieving a Kansas City Cardiomyopathy Questionnaire (KCCQ-12) score ≥75. The trial also explores effects on symptoms, functional capacity, biomarkers, renal function, and major cardiovascular events. The goal is to clarify whether modern low-dose digoxin provides meaningful clinical benefit in contemporary heart failure management.

Temporary MCS With the iVAC 2L Transaortic Device in High-risk PCI

Patients with coronary artery disease and undergoing high-risk percutaneous coronary intervention (PCI) are at increased risk of hemodynamic instability and poor outcomes. Mechanical circulatory support (MCS) devices may offer hemodynamic stabilization during PCI, potentially improving short- and long-term outcomes. The study rationale is to investigate the safety and clinical efficacy of temporary MCS with the iVAC 2L transaortic device in high-risk percutaneous coronary intervention. The transaortic system for short-term circulatory support with pulsatile blood flow iVAC 2L consists of an external membrane pump, a 17Fr diameter catheter for reversed blood flow (intake cannula) with a patented two-way rotary valve. The pump has two chambers, one for blood and one for helium, separated by a flexible diaphragm. The blood chamber connects to the catheter and the air chamber connects to a standard IABP console. The bi-directional valve is located 72 mm from the aspiration tip of the catheter and determines the direction of blood flow. The catheter is advanced retrogradely through the common femoral artery so that the tip is located in the left ventricular (LV) cavity and the valve is in the ascending aorta. Synchronized with the cardiac cycle via ECG, the device draws blood from the LV into the pump chamber during systole and ejects blood from the pump into the ascending aorta during diastole. The primary composite outcome is all-cause mortality, including acute myocardial infarction, stroke and TIA during hospitalization and at Day 360 of follow-up, expressed as a percentage of total patients.

Simple Urine Composition-based Personalized Algorithm for Effective Congestion Relief in Decompensated Heart Failure

The aim of this study is to evaluate the effectiveness of loop diuretic adaptative algorithm that is based on machine learning, urine output prediction tool, in decongestion of acute heart failure patients. A total of 90 patients will be enrolled in the study. Of these, 45 will be assigned to the algorithm-based intervention group, while the remaining 45 will serve as the control group. In the control group, all decisions regarding diuretic therapy will be made solely by the attending physician, without the use of the algorithm. Patients will receive intravenous furosemide, with the initial dose determined by the attending physician. Two hours after administration of the diuretic, a spot urine sample will be collected to measure sodium and creatinine concentrations. Based on these values, the 6-hour urine output will be estimated using the machine learning, urine output prediction tool (http://diuresis.umw.edu.pl). This estimate will guide the diuretic therapy plan for the first 24 hours of hospitalization. On the second day, the procedure will be repeated using the same methodology.

Vietnamese Rapid Acceleration Protocol for Intensifying Drug Therapy in Heart Failure With Reduced Ejection Fraction

VN-RAPID is an open-label, multicenter, randomized controlled trial evaluating the safety and efficacy of in-hospital initiation and rapid up-titration of four-pillar therapy for hospitalized Asian patients with acute heart failure (AHF) and reduced ejection fraction (HFrEF). The study compares a standardized protocol of intensified treatment (high-intensity care arm) with usual care in patients with elevated NT-proBNP levels who are not on optimal HFrEF medications. The high-intensity care arm involves initiation of all four pillars of HFrEF therapy (RAS inhibitor, beta-blocker, MRA, and SGLT2i) before discharge, followed by a structured 6-week outpatient up-titration process with frequent follow-ups. The study aims for 75% of target doses for RAS inhibitors and beta-blockers, considering the lower blood pressure tendency in Asian populations. Participants will be followed for 180 days to assess clinical outcomes.

Evaluating Residual Congestion at Discharge in Acute Heart Failure Patients

Treatment of congestion is one of the main goals in patients hospitalized for acute heart failure. Nevertheless, current evidence shows that decongestion is often not achieved and that residual congestion at discharge is strongly associated with poor outcomes. While this association has been demonstrated, previous studies have primarily focused on single parameters of congestion (physical examination, biomarkers, or imaging features). The aim of the study is to assess residual congestion at discharge using a multiparametric approach and to compare the prognostic value of each evaluation strategy. Additionally, the analysis will be supported by artificial intelligence to develop a multiparametric prognostic algorithm that can provide an improved predictive model compared to standard statistical approaches.

Exogenous KETOne Supplements in Patients Hospitalized for Acute Heart Failure

This is a multicenter, randomized, double-blind, placebo-controlled trial to investigate the clinical efficacy of treatment with exogenous dietary ketone supplement containing 1,3-butanediol in patients hospitalized with acute heart failure (AHF), potentially leading to better clinical outcomes.

Efficacy and Safety of Early Initiation of Vericiguat in Heart Failure After Acute Myocardial Infarction

Heart failure (HF) is a severe cardiovascular disease with extremely high morbidity and mortality rates worldwide, and ischemic cardiomyopathy is an important cause of heart failure. Vericiguat is a soluble guanylate cyclase stimulator which has been verified to improve the cardiovascular outcomes in heart failure patients. The VICTORIA trial excluded patients with acute coronary syndrome in 3 months prior to the study start, so it is still unclear about the efficacy and safety of vericiguat in heart failure after acute myocardial infarction. So we conducted this multi-center, prospective, cohort study to estimate the efficacy and safety of vericiguat in HF patients after acute myocardial infarction.

Acute Heart Failure in Elderly Patients Admitted to the Emergency Department with Acute Dyspnea: a Multimarker Approach Prognostic Study

Background and Rationale: Acute dyspnea is a frequent presenting symptom in emergency departments (ED), with acute heart failure (AHF) being the most common cause leading to hospitalization in elderly patients. AHF in this population presents unique challenges in diagnosis, management, and risk stratification. Current tools for severity assessment and risk stratification (NT-proBNP and echocardiography) have shown limited evolution over the past 20 years and remain insufficient, particularly for elderly patients who predominantly present with heart failure with preserved ejection fraction (HFpEF). Recent European Society of Cardiology (ESC) and American Heart Association (AHA) guidelines specifically call for research on biomarkers within a multi-marker strategy for AHF risk stratification. Research Hypothesis: The study hypothesizes that a combination of biomarkers (NT-proBNP, High-sensitivity Troponin I, ST2, Galectin-3, CD146 and suPAR) will provide prognostic value and effectively stratify risk for early outcomes (90-day mortality and hospital readmission) in patients aged ≥75 years presenting to the ED with acute dyspnea and diagnosed with AHF. Primary Objective: To evaluate the prognostic value of six biomarkers, both individually and in combination, for predicting 90-day all-cause mortality or ED readmission in elderly patients (≥75 years) presenting with acute dyspnea and diagnosed with AHF. Study Design: This is a prospective prognostic study including patients from 7 emergency departments from university and non-university hospitals in France. Study Population: (I) Patients aged ≥75 years presenting to the ED with acute dyspnea meeting at least two criteria: * Respiratory rate ≥25/min * PaO2 ≤70 mmHg * SpO2 ≤92% on room air * PaCO2 ≥45 mmHg and pH ≤7.35 * Oxygen requirement (ii) Have confirmed AHF diagnosis by two expert reviewers based on clinical data, laboratory results (excluding NT-proBNP), ECG, imaging, and specialized cardiac echo Primary Endpoint: Composite endpoint of 90-day all-cause mortality or ED readmission, as recommended by the ESC for evaluating early outcomes in AHF patients. Analysis plan includes: * ROC curves for optimal biomarker thresholds * Kaplan-Meier survival analysis with log-rank tests * Univariate and multivariate Cox regression analyses * Bootstrap methods for confidence intervals

Exploring the Correlations of Lung Ultrasound with Delirium and Outcomes in Acute GEriatrics World: a Multicenter, Prospective, Observational Study from the GRETA Group of the Italian Society of Gerontology and Geriatrics

The purpose of this observational study is to investigate the prognostic relevance of lung ultrasound (LUS) performed on older patients (aged 65 and above) admitted to the hospital with acute respiratory symptoms. The primary objective is to determine if LUS-detected pulmonary abnormalities upon hospital admission are associated with the development of delirium during hospitalization. Secondary objectives include assessing the association between LUS patterns and clinical outcomes such as oxygen supplementation duration, non-invasive ventilation use, mortality, and length of hospital stay. This study involves no interventions and will monitor patients using LUS as part of their regular clinical care in multiple centers.

Heart Risk 6 Scale in Emergency Department Acute Heart Failure Patients

Detect the predictive value of the HEARTRISK6 Scale in Predicting Short-Term Serious Outcomes in emergency department acute heart failure patients in Egyptian population