Acute Heart Failure (AHF)

26

Review clinical trials related to Acute Heart Failure (AHF). Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
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Status: Recruiting

Assessment of Residual Congestion in Acute Decompensated Heart Failure

DESIGN: A prospective, multicenter, observational cohort study including 580 patients admitted for acute decompensated heart failure (ADHF). Ultrasound assessment of congestion (VExUS and LUS) will be performed serially during admission: within 48 hours of admission, at the time diuretic therapy is switched from intravenous to oral, and on the day of discharge. The discharge assessment will serve as the primary predictor. Treating physicians will be blinded to all ultrasound findings. Patients will be followed for 90 days by telephone follow-up and chart review for the primary endpoint, with extended chart review at one year for selected secondary endpoints. AIMS: To determine whether combined ultrasound assessment of venous (VExUS) and pulmonary congestion (LUS) at discharge predicts heart failure readmission and all-cause mortality in patients hospitalized with ADHF. HYPOTHESIS: Abnormal VExUS and/or LUS findings at discharge are associated with a higher risk of heart failure readmission and all-cause mortality after 90 days. PRIMARY ENDPOINT: The primary endpoint is a composite of heart failure readmission and all-cause mortality (time-to-event analysis) after a 90-day period (chart review). Abnormal VExUS will be defined according to criteria from our ongoing validation study. Abnormal LUS is defined as ≥3 B-lines in ≥2 scanning zones per hemithorax (8-zone method) or ≥15 total B-lines overall. The primary analysis will evaluate the association between discharge VExUS and LUS findings and the risk of 90-day heart failure readmission and all-cause mortality using Cox proportional hazards regression. Models will be adjusted for age, sex, and comorbidities. SECONDARY ENDPOINTS: 1. DAOH within 90 days and one year after discharge 2. All-cause mortality within 90 days and one year after discharge 3. Rehospitalization for ADHF within 90 days and one year after discharge 4. Association between discharge VExUS and markers of congestion, including objective markers (jugular venous pressure, peripheral edema, pulmonary rales, and weight change), NT-proBNP, renal function, and echocardiographic measures of cardiac function. 5. Incremental prognostic value of discharge VExUS and LUS beyond standard clinical assessment of congestion (jugular venous pressure, peripheral edema, pulmonary rales, and weight change) for predicting 90-day and one-year heart-failure readmission and all-cause mortality. 6. Post-discharge diuretic use, defined as the change in loop diuretic dose (furosemide-equivalent) from discharge to 30- and 90-day follow-up, and occurrence of diuretic intensification (dose increase or addition of thiazide-type diuretic) within 90 days. Secondary analyses will employ Cox models for time-to-event outcomes (readmission, mortality, diuretic intensification) and linear regression for continuous outcomes (DAOH, change in diuretic dose). The relationship between discharge VExUS/LUS and post-discharge diuretic use will be evaluated both continuously (dose change) and categorically (intensification vs. no intensification). Incremental prognostic value beyond clinical and biochemical markers (e.g., NT-proBNP) will be assessed using nested model comparisons (likelihood ratio tests, AIC, C-index, NRI, IDI). INCLUSION CRITERIA: 1. Adults (≥18 years) admitted with ADHF. 2. Clinical evidence of congestion during admission, indicated by ≥1 of the following: pitting peripheral edema, ascites, elevated jugular venous pressure, or radiologic/ultrasound evidence of pulmonary congestion. 3. Treatment with ≥40 mg i.v. furosemide or equivalent dose loop diuretic during admission. EXCLUSION CRITERIA: 1. Pregnancy 2. Moribund 3. Solitary kidney 4. Inability to provide written consent

Participants needed: 580
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Aarhus University HospitalUpdated: Jul 2, 2026Locations: 3Duration: 90 Days
Eligibility criteria

Adults (≥18 years) admitted with ADHF. [+2]

Pregnancy [+3]

Status: Recruiting

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.

Participants needed: 100
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Assistance Publique - Hôpitaux de ParisUpdated: Jun 25, 2026Locations: 1
Eligibility criteria

Patients ≥18 years [+3]

Known chronic liver disease, defined by a Prothrombic time of < 50%, or any form... [+6]

Status: Recruiting

Sarcopenia in Older Patients Hospitalized for Acute Heart Failure.

Acute heart failure (AHF) is the leading cause of hospitalization in people over 65, with the group with preserved ejection fraction (HFpEF) being the most closely related to aging. Among its comorbidities, sarcopenia stands out, and its assessment requires measurement of muscle mass. Muscle ultrasound is an accessible and economical alternative, although its prognostic value is still uncertain. The presence of common pathophysiological mechanisms between HF-PEF and sarcopenia leads to the study of biomarkers to improve their characterization. Multimodal characterization of sarcopenia, integrating muscle mass and strength with skeletal and cardiac muscle biomarkers, will improve prognostic stratification at discharge in elderly patients with HFpEF hospitalized for ACS. We seek to evaluate the prognostic value of muscle mass estimated by ultrasound, in combination with strength measurements and circulating biomarkers related to sarcopenia, as this could improve the prediction of clinical events after hospitalization for AHF in elderly patients with HFpEF. In addition, ultrasound estimation of muscle mass will be analyzed against BIA, the relationship between skeletal and cardiac muscle will be characterized, and the usefulness of the multimodal approach to sarcopenia will be evaluated. This study is observational, prospective, and single-center. It will include 110 patients hospitalized for AHF aged ≥80 years. Events will be monitored for 6 months after discharge. Variables include clinical data, ultrasound data (lung, VExUS, and muscle mass), congestion markers (BNP, CA125), biomarkers (GDF-15, sST2, BDNF, and myostatin/follistatin), bioimpedance, and dynamometry. Data will be analyzed using regression models and survival analysis to identify prognostic factors. This study has the potential to improve the clinical management of patients with acute heart failure by providing key information on its interaction with sarcopenia. The results could help identify more effective strategies to reduce rehospitalization and mortality in these patients, improving their prognosis and quality of life.

Participants needed: 110
Trial details
Age: 80+Biological sex: AllType: ObservationalSponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y CajalUpdated: Jun 23, 2026Locations: 1
Eligibility criteria

Patients with HF-pEF (LVEF ≥50%), hospitalized for AHF, with signs of fluid over... [+2]

End-of-life care. [+2]

Status: Recruiting

Digoxin After Acute Heart Failure (DIG-DICA)

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.

Participants needed: 120
Trial details
Phase: Phase 4Age: 18-120Biological sex: AllType: InterventionalSponsor: Hospital General de Agudos "Dr. Cosme Argerich"Updated: Jun 2, 2026Locations: 1
Eligibility criteria

Male or female ≥ 18 years of age who have signed written informed consent and ar... [+4]

Resting heart rate < 60 bpm in sinus rhythm or < 70 bpm in atrial fibrillation. [+17]

Status: Recruiting

Acute Heart Failure Registry

To evaluate the clinical utility of quantitative electrocardiography (Quantitative ECG, QCG) by analyzing its associations with clinical characteristics and laboratory findings in patients hospitalized with acute heart failure.

Participants needed: 400
Trial details
Age: 19+Biological sex: AllType: ObservationalSponsor: Jin Joo ParkUpdated: Jun 1, 2026Locations: 1Duration: 1 Year
Eligibility criteria

Adults aged 19 years or older who were admitted to the Department of Cardiology... [+2]

History of congenital heart disease [+2]

Status: Recruiting

Pre-discharge Influenza Vaccination in Patients Hospitalized for Acute Cardiac Conditions

Patients hospitalized for acute cardiac conditions-including acute myocardial infarction, acute heart failure, pulmonary embolism, arrhythmias, and hypertensive emergencies-represent a heterogeneous population at very high risk of recurrent cardiovascular events. Influenza infection may act as a trigger for adverse cardiovascular events. Given the persistently low influenza vaccination uptake despite evidence-based benefits observed in vulnerable populations, including patients with cardiac conditions, new strategies to improve vaccination coverage are being explored. Recently, increasing attention has been directed toward an approach already used in fields such as neonatology, where vaccinations are administered prior to hospital discharge. In this investigator-initiated, single-center, randomized, open-label interventional study, we will evaluate whether influenza vaccination administered within 24 hours before hospital discharge in patients hospitalized for acute cardiac conditions is safe and effective in reducing subsequent infections, cardiovascular events, and mortality during the 6 months following hospitalization.

Participants needed: 400
Trial details
Phase: Phase 4Age: 18+Biological sex: AllType: InterventionalSponsor: Wroclaw Medical UniversityUpdated: Jun 1, 2026Locations: 1
Eligibility criteria

Acute cardiac hospitalization, [+2]

History of a severe adverse reaction to influenza vaccination, [+3]

Status: Not yet recruiting

Urinary Chloride and Sodium Changes and Residual Congestion in Acute Heart Failure

The goal of this observational study is to learn how changes in urinary sodium and chloride levels relate to fluid overload and short-term outcomes in patients hospitalized with acute heart failure (AHF). The main questions it aims to answer are: * Do changes over time in urinary sodium and chloride reflect how well excess fluid is being removed during hospitalization? * Are these changes associated with residual congestion at discharge and with the risk of worsening heart failure or death after discharge? Participants hospitalized for AHF and treated with intravenous diuretics as part of their usual care will have clinical assessments, blood and urine tests, and echocardiographic evaluations collected at several time points during their hospital stay. Researchers will also record clinical outcomes, including worsening heart failure or death, at 30 days and 3 months after discharge.

Participants needed: 223
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y CajalUpdated: May 22, 2026Locations: 4
Eligibility criteria

Provision of written informed consent prior to any study-related procedures; [+7]

Symptomatic hyponatremia or plasma sodium level ≤125 mmol/L; [+8]

Status: Not yet recruiting

TACTIC-HF: Sequential Diuretic Strategies in Ambulatory Worsening Heart Failure

TACTIC-HF is a prospective randomized crossover trial designed to compare three ambulatory diuretic strategies in patients with worsening heart failure treated in a specialized heart failure day-hospital program. Participants will receive sequential treatment with: 1. intravenous furosemide alone, 2. intravenous furosemide combined with oral acetazolamide, and 3. intravenous furosemide combined with oral hydrochlorothiazide. The primary objective is to compare short-term natriuretic response between strategies. Secondary objectives include assessment of urine output, congestion parameters, and renal/electrolyte safety. Each participant will undergo repeated outpatient treatment sessions separated by washout periods, with standardized clinical and laboratory monitoring performed during each visit. The study aims to evaluate pragmatic and clinically applicable ambulatory decongestion strategies using approved therapies commonly available in real-world practice.

Participants needed: 60
Trial details
Phase: Phase 4Age: 18+Biological sex: AllType: InterventionalSponsor: Lucrecia Maria BurgosUpdated: May 18, 2026
Eligibility criteria

Age ≥18 years Chronic heart failure diagnosis according to current guideline def...

Hemodynamic instability or cardiogenic shock Requirement for immediate hospitali...

Status: Recruiting

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.

Participants needed: 420
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Gødstrup HospitalUpdated: May 7, 2026Locations: 1
Eligibility criteria

Age >18 years [+4]

Requirement at admission for ICU-level care, or IV inotropic/vasopressor therapy... [+3]

Status: Recruiting

Training Medical Residents in the Use of the Venous Excess UltraSound (VExUS) Score for Bedside Volume Assessment.

This randomized controlled trial evaluates the effectiveness of two training approaches (in-person versus remote) for teaching medical residents to apply the Venous Excess Ultrasound (VExUS) score for bedside volume assessment in patients with acute heart failure. Resident performance will be compared to that of expert physicians certified in abdominal and duplex sonography.

Participants needed: 23
Trial details
Biological sex: AllType: InterventionalSponsor: Insel Gruppe AG, University Hospital BernUpdated: Apr 21, 2026Locations: 1
Eligibility criteria

Medical residents in general internal medicine [+2]

SGUM certification in abdominal ultrasound [+2]

Status: Recruiting

Prolonged Nasogastric Administration of Ketones in Decompensated Heart Failure

This study will evaluate the feasibility and safety of achieving therapeutic concentrations of beta-hydroxybutyrate using continuous infusion of D-beta-hydroxybutyrate monoester administered via a nasogastric tube in patients with acutely decompensated heart failure with reduced left ventricular ejection fraction.

Participants needed: 12
Trial details
Phase: Phase 4Age: 18+Biological sex: AllType: InterventionalSponsor: Institute for Clinical and Experimental MedicineUpdated: Apr 14, 2026Locations: 1
Eligibility criteria

LVEF <35% [+1]

Severe liver failure [+5]

Status: Recruiting

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.

Participants needed: 600
Trial details
Phase: Phase 4Age: 18+Biological sex: AllType: InterventionalSponsor: Lakeland Regional Health Systems, Inc.Updated: Apr 9, 2026Locations: 1
Eligibility criteria

Have a primary diagnosis of acute decompensated heart failure, and [+5]

Admission to the intensive care unit [+7]

Status: Recruiting

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

Participants needed: 600
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: University Heart Center Freiburg - Bad KrozingenUpdated: Apr 7, 2026Locations: 4
Eligibility criteria

Patients hospitalized with acute heart failure SCAI stage B - E.

Not capable of providing informed consent due to reasons not attributable to car... [+1]

Status: Not yet recruiting

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.

Participants needed: 740
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: University Hospital, AngersUpdated: Apr 3, 2026Locations: 10
Eligibility criteria

Adult patient (≥18 years) [+8]

Shock state suggesting cardiogenic shock and/or severe pulmonary embolism [+10]

Status: Recruiting

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.

Participants needed: 1,014
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y CajalUpdated: Mar 19, 2026Locations: 25
Eligibility criteria

Hospitalized due to heart failure as the main reason, including the presence of... [+1]

Height less than 150 cm or greater than 190 cm or body mass index (BMI) less tha... [+6]

Status: Not yet recruiting

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.

Participants needed: 128
Trial details
Phase: Phase 2, Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: Hospital de Clinicas de Porto AlegreUpdated: Mar 18, 2026Locations: 1
Eligibility criteria

Men or women aged 18 years or older. [+5]

Patients under evaluation for heart transplantation or with prior heart transpla... [+12]

Status: Not yet recruiting

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).

Participants needed: 144
Trial details
Age: 75+Biological sex: AllType: InterventionalSponsor: Centre Hospitalier Universitaire de BesanconUpdated: Feb 6, 2026
Eligibility criteria

Age ≥ 75 years [+8]

Type 1 diabetes [+9]

Status: Recruiting

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.

Participants needed: 100
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: National Medical Research Center for Cardiology, Ministry of Health of Russian FederationUpdated: Sep 8, 2025Locations: 1
Eligibility criteria

Multidisciplinary heart team consensus for high-risk PCI. HR-PCI was defined as... [+1]

Femoral artery diameter < 6.0mm [+13]

Status: Recruiting

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.

Participants needed: 90
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Wroclaw Medical UniversityUpdated: Aug 12, 2025Locations: 2
Eligibility criteria

Adult patients over 18 years of age who provide informed consent [+4]

End-stage kidney disease requiring renal replacement therapy [+2]

Status: Recruiting

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.

Participants needed: 500
Trial details
Age: 18-75Biological sex: AllType: InterventionalSponsor: University Medical Center Ho Chi Minh City (UMC)Updated: Aug 5, 2025Locations: 4
Eligibility criteria

Hospital admission with diagnosis of acute heart failure assessed by clinical si... [+10]

Clearly documented intolerance to high doses of RASi/ARNi or beta-blockers [+19]

Status: Recruiting

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.

Participants needed: 500
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Consorci Sanitari IntegralUpdated: Jul 18, 2025Locations: 1
Eligibility criteria

Age ≥ 18 years. [+4]

Known diagnosis of septicemia. [+8]

Status: Recruiting

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.

Participants needed: 250
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Aarhus University HospitalUpdated: Jun 5, 2025Locations: 8
Eligibility criteria

Documented new or worsening symptoms due to heart failure with at least one of t... [+3]

Current hospitalization for AHF triggered by significant arrhythmia (atrial fibr... [+18]

Status: Not yet recruiting

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.

Participants needed: 200
Trial details
Phase: Phase 4Age: 18+Biological sex: AllType: InterventionalSponsor: Dongying ZhangUpdated: Feb 6, 2025Locations: 1
Eligibility criteria

Age ≥ 18 years old [+4]

Plan to undergo staged revascularization or if the criminal coronary artery has... [+10]

Status: Not yet recruiting

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

Participants needed: 185
Trial details
Age: 75+Biological sex: AllType: ObservationalSponsor: Centre Hospitalier Universitaire de BesanconUpdated: Nov 18, 2024
Eligibility criteria

Respiratory rate ≥25/min [+6]

No written consent for data use in the READ-MA-PRONO study

Status: Not yet recruiting

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.

Participants needed: 480
Trial details
Age: 65+Biological sex: AllType: ObservationalSponsor: University of Milano BicoccaUpdated: Nov 1, 2024Locations: 1Duration: 3 Months
Eligibility criteria

Patients aged 65 years or older, admitted directly from the Emergency Room or Em... [+5]

Presence of delirium upon admission. [+5]