This observational study is conducted to assess the evolution of multiple markers of congestion over 4 weeks after a worsening heart failure (WHF) event treated in an outpatient unit
This is a multicenter, non-randomized, observational study designed to assess the evolution of multiple markers (physical, echocardiographic, and biomarkers) of congestion in 40 patients with chronic heart failure (CHF) treated over 4 weeks with 40 to 120 mg daily oral furosemide after an event of WHF treated in an outpatient unit. Patients at selected centers may participate in a telemetry ancillary study, in which real-time, continuous, non-invasive measurements of physiologic parameters of heart failure will be obtained through use of a wearable medical telemetry device. Approximately 40 patients with CHF with reduced or mildly reduced left ventricular ejection fraction (EF \< 50%) who had an admission for WHF in the preceding 1-12 months and who develop symptoms of WHF over the week before presentation to an outpatient clinic will be enrolled. Patients will attend five outpatient visits over the course of 4 weeks. At each visit, the patient's vital signs will be measured, clinical assessments (NYHA class, jugular vein distension, peripheral edema score, pulmonary rales) will be performed, and blood samples for central assays will be obtained. Detailed echocardiographic examination will be performed prior to enrolment in the first visit and at Visit 5. Biomarkers related to cardiac and renal function will be measured in blood and urine samples at each visit.
Study Type
OBSERVATIONAL
Enrollment
42
This is an observational study designed to assess the evolution of multiple markers of congestion over 4 weeks after a WHF event treated in an outpatient unit
Institute of Cardiology Levon Hovhannisyan
Yerevan, Armenia
Erebuni Medical Center
Yerevan, Armenia
Health Institution Medico Laser, Cardiology ward
Banja Luka, Bosnia and Herzegovina
Universty Clinical Hospital Mostar, Clinic for Internal diseases with dyalisis center, Clinical ward for cardiology
Mostar, Bosnia and Herzegovina
Change in E/e' ratio
Change in E/e' ratio, measured on echocardiography
Time frame: Screening (Visit 1) and week 4 (beginning of Visit 5).
Changes in Left Ventricular End-Diastolic Diameter (LVEDD)
Changes in LVEDD measured on echocardiography from screening to Week 4
Time frame: From screening to 4 weeks
Changes in Left Ventricular End-Systolic Diameter (LVESD)
Changes in LVESD measured on echocardiography from screening to Week 4
Time frame: From screening to 4 weeks
Changes in Left Ventricular End-Diastolic Volume (LVEDV)
Changes in LVEDV measured on echocardiography from screening to Week 4
Time frame: From screening to 4 weeks
Changes in Left Ventricular End-Systolic Volume (LVESV)
Changes in LVESV measured on echocardiography from screening to Week 4
Time frame: From screening to 4 weeks
Changes in Left Ventricular Ejection Fraction (LVEF)
Changes in LVEF measured on echocardiography from screening to Week 4
Time frame: From screening to 4 weeks
Changes in mitral E-velocity
Changes in mitral E-velocity measured on echocardiography from screening to Week 4
Time frame: From screening to 4 weeks
Changes in mitral A-velocity
Changes in mitral A-velocity measured on echocardiography from screening to Week 4
Time frame: From screening to 4 weeks
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Changes in E' velocity
Changes in E' velocity measured on echocardiography from screening to Week 4
Time frame: From screening to 4 weeks
Changes in Right Ventricular Systolic Pressure (RVSP)
Changes in RVSP measured on echocardiography from screening to Week 4
Time frame: From screening to 4 weeks
Changes in Tricuspid Annular Pulmonary Systolic Excursion (TAPSE)
Changes in TAPSE measured on echocardiography from screening to Week 4
Time frame: From screening to 4 weeks
Changes in S' velocity
Changes in S' velocity measured on echocardiography from screening to Week 4
Time frame: From screening to 4 weeks
Changes in Inferior Vena Cava (IVC) diameter
Changes in IVC (minimum and maximum) measured on echocardiography from screening to Week 4
Time frame: From screening to 4 weeks
Changes in Left Atrium (LA) surface
Changes in LA surface measured on echocardiography from screening to Week 4
Time frame: From screening to 4 weeks
Changes in Right Atrium (RA) surface
Changes in RA surface measured on echocardiography from screening to Week 4
Time frame: From screening to 4 weeks
Changes in patient-reported dyspnea
Weekly changes in patient-reported dyspnea
Time frame: From screening to 4 weeks
Changes in clinically-assessed jugular venous pulse
Weekly changes in clinically-assessed jugular venous pulse
Time frame: From screening to 4 weeks
Changes in clinically-assessed peripheral edema
Weekly changes in peripheral edema
Time frame: From screening to 4 weeks
Changes in estimated Glomerular Filtration Rate (eGFR)
Changes in eGFR between screening, Week 2 and Week 4 visit.
Time frame: From screening to 4 weeks
Changes in serum creatinine
Changes in serum creatinine between screening, Week 2 and Week 4 visit.
Time frame: From screening to 4 weeks
Changes in NT-proBNP
Changes in NTproBNP between screening, Week 2 and Week 4 visit.
Time frame: From screening to 4 weeks
Changes in high sensitivity Troponin T (HsTnT)
Changes in HsTnT between screening, Week 2 and Week 4 visit.
Time frame: From screening to 4 weeks
Changes in Kansas City Cardiomyopathy Questionnaire (KCCQ)-12
Changes in KCCQ-12 inclusive of total symptoms score and sub scores from screening to Week 4
Time frame: From screening to 4 weeks
Weekly changes in telemetered parameters in patients wearing the wrist-worn device (Philips Health Band)
Weekly changes in activity in those patients wearing the wrist-worn device (Philips Health Band)
Time frame: From screening to 4 weeks