Last updated: March 5, 2024
Sponsor: Region Skane
Overall Status: Terminated
Phase
N/A
Condition
Chest Pain
Congestive Heart Failure
Heart Failure
Treatment
Magnetic resonance imaging
Pulmonary scintigraphy
Peripheral venous pressure
Clinical Study ID
NCT04901039
2020-03088
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion criteria: Hospitalization for decompensated heart failure is defined as an event that meets all ofthe following criteria:
- The patient is admitted to the hospital with a primary diagnosis of HF (previous echomandatory)
- The patient's length-of-stay in hospital extends for at least 24 hours
- The patient exhibits documented new or worsening symptoms due to HF on presentation,including at least ONE of the following:
- Dyspnea (dyspnea with exertion, dyspnea at rest, orthopnea, paroxysmal nocturnaldyspnea)
- Decreased exercise tolerance
- Fatigue
- Other symptoms of worsened end-organ perfusion or volume overload (as determinedby the medical judgement of the investigator)
- The patient has objective evidence of new or worsening HF, consisting of at least twophysical examination findings OR one physical examination finding and at least ONElaboratory criterion, including:
- Physical examination findings considered to be due to heart failure, includingnew or worsened:
- Peripheral edema
- Increasing abdominal distention or ascites (in the absence of primaryhepatic disease)
- Pulmonary rales/crackles/crepitations
- Increased jugular venous pressure and/or hepatojugular reflux
- S3 gallop
- Clinically significant or rapid weight gain thought to be related to fluidretention
- Laboratory evidence of new or worsening HF, if obtained within 24 hours ofpresentation, including:
- Increased B-type natriuretic peptide (BNP)/ N-terminal pro-BNP (NT-proBNP)concentrations consistent with decompensation of heart failure (such as BNP > 500 pg/mL or NT-proBNP > 2,000 pg/mL). In patients with chronicallyelevated natriuretic peptides, a significant increase should be noted abovebaseline.
- Radiological evidence of pulmonary congestion
- Non-invasive diagnostic evidence of clinically significant elevated left- orright-sided ventricular filling pressure or low cardiac output. For example,echocardiographic criteria could include: E/e' > 15 or D-dominant pulmonaryvenous inflow pattern.
- Invasive diagnostic evidence with right heart catheterization showing apulmonary capillary wedge pressure (pulmonary artery occlusion pressure) ≥ 18 mmHg, central venous pressure ≥ 12 mmHg, or a cardiac index < 2.2L/min/m2
- The patient receives initiation or intensification of treatment specifically for HF,including at least one of the following:
- Augmentation in oral diuretic therapy
- Intravenous diuretic or vasoactive agent (e.g., inotrope, vasopressor, orvasodilator)
- Mechanical or surgical intervention, including:
- Mechanical circulatory support (e.g. intra-aortic balloon pump, ventricularassist device, extracorporeal membrane oxygenation, total artificial heart)
- Mechanical fluid removal (e.g., ultrafiltration, hemofiltration, dialysis)
Exclusion
Exclusion Criteria:
• Acute coronary syndrome, cardiogenic chock
Study Design
Total Participants: 21
Treatment Group(s): 5
Primary Treatment: Magnetic resonance imaging
Phase:
Study Start date:
April 14, 2022
Estimated Completion Date:
June 01, 2023
Connect with a study center
Helsingborg General Hospital
Helsingborg,
SwedenSite Not Available
Skåne University Hospital
Lund,
SwedenSite Not Available
Skåne University Hospital
Malmö,
SwedenSite Not Available

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