Multiparametric Assessment of Cardiac Congestion in Outpatient Worsening Heart Failure (NCT05747820) | Clinical Trial Compass
CompletedNot Applicable
Multiparametric Assessment of Cardiac Congestion in Outpatient Worsening Heart Failure
Armenia, Bosnia and Herzegovina42 participantsStarted 2022-09-28
Plain-language summary
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
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Male or female patients ≥ 18 and \< 80 years of age.
✓. Previous documented hospital admission for HF between 12 months and 1 month prior to Screening.
✓. Ambulatory patients with a diagnosis of stable NYHA class II - III HF with left ventricular ejection fraction \<50%, who experience a worsening of heart failure (WHF), with worsening signs and/or symptoms of heart failure requiring institution or up titration of loop diuretic therapy, in the week preceding their visit to the outpatient HF clinic and with at the time of Screening:
✓. Dyspnea and at least one symptom of congestion (rales, orthopnea, peripheral oedema)
✓. Imaging confirmation of congestion as defined by either pulmonary congestion on chest X-ray or at least 2 B-lines by lung ultrasound.
✓. Stable oral doses of ACEi, ARB or ARNi, beta-blocker, mineralocorticoid antagonist (MRA), and SGLT2i for \> 1 month prior to screening.
✓. An increase in the prescribed oral loop diuretic dose up to 120 mg daily furosemide or equivalent\*for the treatment of the WHF event.
✓. Biomarker profile suggestive of significant HF inclusive of NT-proBNP ≥1500 pg/ml, and elevated TnT from 15 ng/L (0.015 mcg/L) to 150 ng/L (0.15 mcg/L) or equivalent TnI using ultrasensitive assay.
Exclusion criteria
✕. Significant pulmonary disease contributing substantially to the patients' dyspnea such as FEV1\< 1 liter or need for chronic steroid therapy.
✕. Myocardial infarction, unstable angina, ICD or CRT implantation, or cardiac surgery, including percutaneous transluminal coronary intervention, within past 3 months.
What they're measuring
1
Change in E/e' ratio
Timeframe: Screening (Visit 1) and week 4 (beginning of Visit 5).
2
Changes in Left Ventricular End-Diastolic Diameter (LVEDD)
Timeframe: From screening to 4 weeks
3
Changes in Left Ventricular End-Systolic Diameter (LVESD)
Timeframe: From screening to 4 weeks
4
Changes in Left Ventricular End-Diastolic Volume (LVEDV)
Timeframe: From screening to 4 weeks
5
Changes in Left Ventricular End-Systolic Volume (LVESV)
Timeframe: From screening to 4 weeks
6
Changes in Left Ventricular Ejection Fraction (LVEF)
✕. History of heart transplant or on a transplant list or using or planned to be implanted with a ventricular assist device.
✕. Significant uncontrolled arrythmia such as atrial fibrillation with a persistent heart rate \> 120 beast/minute, any bradyarrhythmia with a persistent heart rate \< 50 beats/min, sustained supraventricular tachycardia, any evidence of tri-fascicular block by ECG.
✕. Sustained ventricular arrhythmia with syncopal episodes within past 3 months that is untreated.
✕. Presence of any hemodynamically moderate or severe valvular stenosis or regurgitation, except for moderate mitral or tricuspid regurgitation secondary to left ventricular dilatation. Presence of hemodynamically significant obstructive lesions of left ventricular outflow tract.
✕. Stroke or TIA within the past 3 months.
✕. Primary or alcoholic liver disease considered to be life threatening.
9
Changes in E' velocity
Timeframe: From screening to 4 weeks
10
Changes in Right Ventricular Systolic Pressure (RVSP)
Timeframe: From screening to 4 weeks
11
Changes in Tricuspid Annular Pulmonary Systolic Excursion (TAPSE)
Timeframe: From screening to 4 weeks
12
Changes in S' velocity
Timeframe: From screening to 4 weeks
13
Changes in Inferior Vena Cava (IVC) diameter
Timeframe: From screening to 4 weeks
14
Changes in Left Atrium (LA) surface
Timeframe: From screening to 4 weeks
15
Changes in Right Atrium (RA) surface
Timeframe: From screening to 4 weeks
16
Changes in patient-reported dyspnea
Timeframe: From screening to 4 weeks
17
Changes in clinically-assessed jugular venous pulse
Timeframe: From screening to 4 weeks
18
Changes in clinically-assessed peripheral edema
Timeframe: From screening to 4 weeks
19
Changes in estimated Glomerular Filtration Rate (eGFR)
Timeframe: From screening to 4 weeks
20
Changes in serum creatinine
Timeframe: From screening to 4 weeks
21
Changes in NT-proBNP
Timeframe: From screening to 4 weeks
22
Changes in high sensitivity Troponin T (HsTnT)
Timeframe: From screening to 4 weeks
23
Changes in Kansas City Cardiomyopathy Questionnaire (KCCQ)-12
Timeframe: From screening to 4 weeks
24
Weekly changes in telemetered parameters in patients wearing the wrist-worn device (Philips Health Band)