Trial · NCT06556810
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety of IC14 treatment | 0-28 days | safety measured by treatment-emergent adverse events, including abnormal laboratory values |
| Primary | Anti-Drug Antibodies following IC14 treatment | 0-28 days | anti-drug antibodies |
| Secondary | C-reactive protein, biomarker of inflammation | baseline, 24 hours, 72 hours or discharge, Day 10, Day 29 | area under the curve (0 \[normal\]; 1-10 mg/dL \[moderate elevation\]; \> 10 mg/dL \[marked elevation\] per time) |
| Secondary | B-type natriuretic peptide, biomarker of heart failure | baseline, 24 hours, 72 hours or discharge, Day 10, Day 29 | absolute value (\<100 pg/mL \[normal\], \>=100 pg/mL \[heart failure\]) |
| Secondary | Estimated glomerular filtration rate, biomarker of heart failure | baseline, 72 hours or discharge, Day 10, Day 29 | absolute value(\>=90 ml/min/1.73 m2 \[normal\]; 60-89 \[possible impairment\]; 15-59 \[impairment\]; \<15 \[renal failure\]) |
| Secondary | Urine sodium | baseline, 24 hours, 72 hours or discharge | absolute value (40-220 milliequivalents/day) |
| Secondary | Dyspnea Visual Analogue Scale | baseline, 24 hours, 72 hours, Day 10, Day 29, and 3 months (virtual). | 10-cm Visual Analogue Scale |
| Secondary | Congestion Score | baseline, 24 hours, 72 hours, Day 10, and Day 29 | a composite score of one point for peripheral edema, jugular venous distension ≥10 cm, pulmonary rales, or S3 gallop (0 \[good\] to 4 \[poor\]) |
| Secondary | Loop diuretic requirement | during the first 72 hours of hospitalization | total loop diuretic requirement (in furosemide equivalents) as calculated from concomitant medication listings |
| Secondary | Doppler echocardiogram | baseline, Day 10 | Change from baseline in left ventricular ejection fraction (left ventricular ejection fraction (\>52% male, \>54% female \[normal\]) |
| Secondary | Echocardiogram | baseline, Day 10 | Change from baseline in left ventricular global longitudinal strain (normal 21%) |
| Secondary | Non-invasive hemodynamic assessment | baseline, 24 hours, 72 hours, Day 1 | Measure of cardiac output |
| Secondary | Bioimpedance analysis | baseline, 24 hours, 72 hours, Day 1 | Measure of extracellular fluid as a marker of heart failure |
| Secondary | Cardiopulmonary exercise test | Day 10 | aerobic exercise capacity (peak oxygen consumption \[VO2\]; \<30 mL/kg/min \[sedentary\]) |
| Secondary | Pharmacokinetic determination of half-life, maximum concentration and area-under-the-curve | baseline, 15 minutes, 6 hours, 24 hours, 72 hours, Day 10, Day 29 | serum IC14 level |
| Secondary | Pharmacodynamics | Day 10, Day 29 | Duration of monocyte CD14 receptor occupancy \>90% |
| Secondary | Ex-vivo leukocyte release assay | Day 10 | Lipopolysaccharide-stimulated release of interleukin 6 |
| Secondary | Kansas City Cardiomyopathy Questionnaire | baseline to 3 months | Questionnaire for the patient that reports on 23 aspects of how heart failure affects the patient's life (0\[worst symptoms/limitations\]-100\[least symptoms/limitations and excellent quality of life\]) |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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