Clinical Research Directory

Characterisation of phenotYpes in aCute Heart faiLure patiEnts

An observational cohort study to evaluate the benefit of functional parameters, radiomics and blood biomarkers to predict the outcome of patients with acute heart failure.

Investigating aCute heArt failuRe Decongestion Guided by Lung UltraSonography

The goal of this clinical trial is to investigate whether a lung ultrasonography (LUS)-guided decongestion strategy in adults hospitalized for acute heart failure (AHF) can improve patient-centered outcomes. The main questions it aims to answer are: * Does this strategy shorten the length of stay and reduce early hospital readmissions? * Does this strategy improve patients' symptoms and quality of life ? Researchers will compare LUS to physical examination (PE).

Pharmacological Optimization in Prevention in Heart Failure: A Sex-gap?

The goal of this clinical trial is to learn whether a rapid and intensive optimization of heart failure medications in women can improve outcomes after hospitalization for heart failure. It will also investigate the safety and the tolerance of these treatments when given at full guideline-recommended doses. The main questions it aims to answer are: 1. Does intensive medication optimization reduce death or hospital readmissions for heart failure within one year? 2. Do women benefit as much as men from intensive and full-dose heart failure therapy? 3. Is this treatment protocol safe and feasible also in women? Researchers will compare two groups of women hospitalized for heart failure: * High-intensity care: starting and increasing all recommended heart-failure medications as quickly as possible and monitoring patients closely during the first weeks after discharge. * Usual care: medications are started and adjusted gradually, according to the judgment of the treating cardiologist and the patient's usual care team. The study will follow participants for 12 months to see whether the high-intensity strategy reduces death, hospital readmission for heart failure, or worsening symptoms. It will also evaluate side effects, medication tolerance, and quality of life. Participants will be randomly assigned to one of the two groups, attend regular follow-up visits for one year, complete a short quality-of-life questionnaire (EQ-5D). This study will include about 360 women from 13 hospitals in Italy. It is sponsored by IRCCS Policlinico San Donato and funded by the Italian Medicines Agency (AIFA).

Integrating Aerobic, Respiratory, and Cognitive Training in Acute Heart Failure

The purpose of this study is to investigate the impact of integrating aerobic, respiratory and cognitive training in acute heart failure.

Ketone Ester for Treatment Of Acute Heart Failure

Ketones have been suggested to have significant physiological effects in patients with heart failure. Potential mechanisms for these effects include energy provision for the failing heart and direct protective effects on other organs. Despite the strong physiological rationale, the acute effects of ketone therapy in patients with acute heart failure (AHF) is unclear. AHF is a major healthcare issue, with in-hospital mortality exceeding 10%. Therefore, we propose a vanguard randomized controlled trial to assess the effects of ketone esters in patients with AHF. Sixty patients hospitalized with AHF will be randomized to receive either 25 grams of ketone esters three times per day or a matching placebo for five days, or until death or hospital discharge. We hypothesize that ketone therapy will improve markers of systemic congestion and heart failure symptoms. Primary endpoint will be changes in NT-proBNP levels during therapy. Secondary endpoints will be KCCQ scores, and hemodynamic profile as assessed by echocardiogram. Exploratory endpoints will clinical outcomes including mortality, need for intensive care unit admission, among others.

A Study to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Hospitalized Heart Failure Patients

Finerenone will be compared to placebo to determine efficacy and safety of treatment in patients hospitalized with acute decompensated heart failure (HF) and mildly reduced or preserved left ventricular ejection fraction.

Early Treatment With a Sodium-glucose Co-transporter 2 Inhibitor in High-risk Patients With Acute Heart Failure

The EMPA-AHF trial is a multicentre, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of early initiation of once-daily oral empagliflozin 10 mg in patients hospitalized for patients with acute heart failure (AHF) who are at a high risk of adverse events.

Efficacy and Safety With Early Treatment of Finerenone in Hospitalized Patients With Heart Failure

FACILITATE-HF is a multicenter, randomized, double-blind, placebo-controlled trial designed to determine whether initiation of finerenone during the early phase of hospitalization has beneficial effects in patients with AHF who have left ventricular ejection fraction 40% or more.

Prospective Validation of the CoDE-HF Algorithm for the Diagnosis of Acute Heart Failure

Acute heart failure is a life-threatening condition where the heart is suddenly unable to pump blood around the body. It can be challenging to diagnose because the symptoms often mimic other conditions. Previous studies have showed that delays in making the correct diagnosis result in worse outcomes. We therefore developed a decision-support tool called CoDE-HF that uses a computer algorithm to combine levels of a blood test called NT-proBNP with patient factors to calculate the probability of acute heart failure for an individual. In this project, we wish to evaluate the performance of CoDE-HF in approximately 2,000 patients attending the Emergency Department with suspected acute heart failure. We will store surplus material from their blood tests to measure NT-proBNP and link information from their electronic health records with other routinely collected medical information in regional and national databases in order to evaluate this algorithm.

Randomized Controlled Trial of urinE chemiStry Guided aCute heArt faiLure treATmEnt (ESCALATE)

This is a randomized trial of protocolized diuretic therapy guided by urinary sodium compared to structured usual care in ED patients with AHF. Participants will be recruited following an initial standard evaluation in the ED and randomized in a 1:1 fashion to structured usual care or protocolized diuretic therapy guided by urinary sodium.

Oxygen Targets in Acute Heart Failure With Pulmonary Congestion

This investigator-initiated, prospective, randomized, blinded, multi-center, controlled trial will investigate the effect of a restrictive vs. liberal oxygenation-strategy in patients hospitalized with acute heart failure with pulmonary congestion. Patients will be randomized 1:1 in the emergency department to either liberal or restrictive oxygenation after providing informed written consent. 1. Liberal oxygenation group = SpO2 target of 96%. 2. Restrictive oxygenation group = SpO2 target of 90%. The allocation will be concealed through the use of an oxygen-delivery robot, termed O2MATIC. The study will include 122 patients.

a PRagmatic Observational Study of Congestion proFILes in patiEnts With Acute Heart Failure

The goal of this observational is to study the prevalence of distinct congestion phenotypes and study their association with response to therapy and outcomes in acute heart failure patients. The main question\[s\] it aims to answer \[is/are\]: * Primary objective: to study the prevalence of distinct congestion phenotypes * Other objectives (including): * Response to therapy as assessed by * Natriuresis after 24 hours * Rehospitalization and/or deats after 6 months * Length of hospital stay * Congestion at discharge * Changes in filling pressures over time * Relationship between liver stiffness, as assessed with Fibroscan and congestion * Substudy: glycosaminoglycan netword and endothial glycocalyx Participants will undergo several extra study related measurements: * Assessment of filling pressures with ultrasound * Ultrasound investigation of the lungs and kidneys * Fibroscan of the liver * Sidestream darkfield imaging sublingual * As part of substudy GLYCO-AHF: skin biopsy to determine glycocalyx, as well as salt and water content. * As part of substudy PREACH-AHF: the effects of peripheral venous congestion and endothelial dysfunction on a large screen of plasma proteins

Improving Diagnostic Accuracy for Acute Heart Failure

Acute heart failure is a common reason for emergency department visits and hospitalization, but the diagnosis can be challenging because of non-specific symptoms and signs. The current diagnostic approach to acute heart failure has modest accuracy, leading to delayed diagnosis and treatment, which associate with worse prognosis. Prior work suggests diagnostic accuracy can be improved with the addition of multiple circulating biomarkers discovered through proteomics, and this study will derive and validate a multi-marker model to improve diagnostic accuracy for acute heart failure in the emergency department.

Loop Diuretic Therapy in Acutely Decompensated Heart Failure

DiurHF is a prospective, multicenter, observational, study that compares continuous with intermittent infusion of furosemide in patients admitted with a diagnosis of ADHF. Previous pilot study design was planned to anticipate a larger multicenter trial able to definitively evaluate the optimal loop diuretic use strategy in patients with ADHF.

MRI Assessment of Pulmonary Edema in Acute Heart Failure

Researchers are testing a more accurate way to measure how much fluid is in the lungs (also called pulmonary edema, or "increased lung water") in people with Heart Failure (HF) using MRI (Magnetic Resonance Imaging). There is little known about the exact level of lung water in patients with AHF or how these levels change from the time of hospital admission to discharge. The purpose of this research study is to measure the lung water in patients hospitalized for HF, to determine the change in lung water over the course of hospitalization and treatment, and to find out if lung water levels can predict if patients are higher or lower risk for returning to the hospital or dying from heart failure.

Short and Long Term Prognosis of Patients Admitted to the ED With Acute Heart Failure

Heart failure (HF) is the leading cause of hospitalization ,rehospitalization and mortality for adults over 65 years of age. This study aimed to assess mortality, and hospitalization rates at 30 days and one year after dicharge of patients with heart failure (HF) with reduced ejection fraction (HFrEF) compared to HF with preserved ejection fraction (HFpEF).

The Role of intraABDOminal Pressure and Point Of Care UltraSound to Guide Decongestive Therapy in Heart Failure

Systemic venous congestion is the primary therapeutic target of intravenous loop diuretics in patients admitted for acute heart failure (AHF). Despite their utility, a significant proportion of AHF patients are discharged with persistent clinical symptoms of congestion (residual congestion). Therefore, in recent years, there has been a growing focus on the use of tools (biomarkers, clinical ultrasound) that allow us to optimize diuretic treatment and thereby improve the prognosis of AHF patients. The objective is to analyze whether the strategy of guiding intravenous loop diuretic dosing based on intra-abdominal pressure(IAP) measurements and clinical ultrasound is superior to the conventional strategy employed in daily clinical practice. This study is a randomized, multicenter clinical trial involving consecutive patients admitted with a diagnosis of AHF in the Internal Medicine and Cardiology departments. Patients who meet the inclusion criteria, after signing informed consent, will be randomized into two groups: 1) Diuretic treatment guided by usual clinical practice and 2) Treatment guided by intra-abdominal pressure levels and clinical ultrasound (inferior vena cava and portal Doppler). This strategy will be maintained during the first 72 hours of admission, with a thorough analysis of congestion and diuretic response being conducted.

Cardiac Assessment and Takotsubo-stunning Among COPD-exacerbations In-Hospital

The goal of this prospective observational study is to investigate to what extent acute exacerbation of chronic obstructive pulmonary disease (AE-COPD) triggers Takotsubo-stunning, and how this affects the outcome for these patients. The main questions it aims to answer are: 1. What is cumulative incidence of Takotsubo-stunning in patients hospitalized for AE-COPD at Sahlgrenska University Hospital/S (Gothenburg, Sweden)? 2. Among patients hospitalized for AE-COPD at Sahlgrenska University Hospital/S, what is the risk of in-hospital clinical manifestations of acute heart failure in patients with Takotsubo-stunning compared to those without?

Heart Failure-USB: Prediction and Progression

This retrospective cohort study is to identify triggers of heart failure (HF) development and drivers of HF progression as well as the underlying cardiac disease (phenotype) to identify patients at risk and predict the clinical course of the disease. Data of patients who were hospitalized during the years 2010-2023 with acute coronary syndrome (ACS) and/ or with acute heart failure (AHF) will be collected and analyzed. In a subgroup cohort efficacy and safety of digoxin in patients with acute heart failure triggered by tachyarrhythmia will be evaluated.

Naples Federico II Intensive Cardiac Care Unit Registry (Naples FED2-ICCU Registry)

This protocol proposes to prospectively evaluate current epidemiology, pharmacologic and invasive management and clinical outcomes of patients with acute cardiovascular diseases admitted at our ICCU.

Optimal Diuretic Therapies for Acute Heart Failure With Volume Overload

Aim to identify the best strategy for treating acute heart failure (AHF) with volume overload, particularly focusing on patients resistant to standard loop-diuretics. The trial is a double-blinded, randomized, controlled, multicenter study. Its primary objective is to compare the efficacy of loop-diuretics combined with either Metolazone or Acetazolamide, against loop-diuretics alone. The trial will also determine the optimal type of loop-diuretic to use. Eligible participants include adults over 18 years hospitalized with AHF and volume overload, showing signs of congestion and at risk of diuretic resistance. Exclusions apply to those with acute coronary syndrome, low systolic blood pressure, prior renal therapy, or previous treatment with Acetazolamide or Metolazone. The primary outcome is the number of days alive and out-of-hospital by day 30. Secondary outcomes include a composite clinical benefit at 30 days, Kansas City Cardiomyopathy Questionnaire (KCCQ) scores, and successful decongestion 72 hours post-inclusion. The trial aims to enroll about 1,041,939 patients across three treatment arms over three years. The minimal important difference is set as a reduction in out-of-hospital days by at least two days, with an anticipated low dropout rate. The study's power is calculated to be 80% with an adjusted alpha level for comparing the three diuretic groups.

Assessing the Clinical Outcomes of Dapagliflozin Versus Acetazolamide in Patients With Acute Heart Failure

This study investigates the comparative clinical outcomes of dapagliflozin, an SGLT-2 inhibitor, versus acetazolamide, a carbonic anhydrase inhibitor, in patients hospitalized with acute heart failure (AHF). The trial aims to assess the effectiveness of these drugs in improving natriuretic and diuretic responses and shortening hospital stays. Dapagliflozin and acetazolamide will be added to standard loop diuretic therapy, and their safety profiles will be evaluated to identify potential side effects. This research seeks to provide evidence for incorporating these drugs into AHF management, with the potential to improve clinical outcomes.

Optimized Treatment of Pulmonary Edema or Congestion

Background: Intravenous (IV) loop-diuretics have been a key component in treating pulmonary edema since the nineteen sixties and has a Class 1 recommendation in the 2021 European Society of Cardiology guidelines for heart failure. Conversely, vasodilation was downgraded in the treatment of acute heart failure due to a lack of trials that compare vasodilation with loop-diuretics in a hyperacute clinical setting. This clinical equipoise will be tested in a trial including patients with pulmonary congestion immediately at hospital admission. Primary objective: To determine the superior strategy of loop-diuretics (furosemide), vasodilation (nitrates) or the combination during emergency treatment. Design: Investigator-initiated, randomized, double-blinded, placebo-controlled trial with 1:1:1 allocation. Intervention: Intervention-phase will last 6 hours from study-inclusion, and patients will be allocated to one of three groups: * Boluses of 40 mg IV furosemide + nitrate-placebo as soon as possible and repeated up to 10 times. * Boluses of 3 mg IV isosorbide dinitrate + furosemide-placebo as soon as possible. * Boluses of both 3 mg IV isosorbide dinitrate + of 40 mg as soon as possible.

Prognostic Markers of Acute Heart Failure With Chronic Kidney Disease

Acute heart failure (AHF) is defined as new or worsening of symptoms and signs of heart failure and is the most frequent cause of unplanned hospital admission in elderly patients. N-terminal pro-brain natriuretic peptide (NT-pro-BNP) is one of the most developed prognostic markers for AHR patients and. NT-pro-BNP has limitations in terms of diagnostic or predictive accuracy in patients with chronic kidney disease (CKD). Plasma proteomics have the potential to examine underlying pathophysiological and prognostic roles, so we compared the plasma proteomic signature to predict outcomes of patients with or without CKD hospitalized for AHF.