ACTIVE_NOT_RECRUITING

IC14 for Treatment of Acute Decompensated Heart Failure

Conditions

Acute Decompensated Heart Failure Congestive Heart Failure Left Heart Failure Heart Failure

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this clinical trial is to learn if drug atibuclimab (IC14) works to treat adults hospitalized with acute decompensated heart failure (ADHF). It will also learn about the safety of IC14. The main questions it aims to answer are: Is the drug IC14 safe in patients with ADHF? What are the IC14 drug levels in the bloodstream after treatment with IC14? What is the impact of IC14 treatment on markers of disease in the bloodstream? What is the impact of IC14 treatment on measures of heart failure? There is no placebo arm in this study. Participants will: Take drug IC14 once via an intravenous infusion After the infusion, be visited in the hospital or visit the clinic 5 times for checkups and tests Answer questions about their medical status via a phone call 3 months after the infusion

Official Title

Phase 1b Pilot Study to Evaluate Atibuclimab (IC14) for Treatment of Acute Decompensated Heart Failure

Quick Facts

Study Start:2024-10-17

Study Completion:2026-01-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06556810

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Primary diagnosis for hospitalization is decompensated heart failure established as the finding at admission of both conditions listed below: 1. dyspnea or respiratory distress or tachypnea at rest or with minimal exertion; and 2. evidence of elevated cardiac filling pressure or pulmonary congestion (at least one of the conditions must be met): * Pulmonary congestion/edema a physical exam OR chest x-ray; * plasma BNP levels ≥200 pg/ml or N-terminal-proBNP ≥600 pg/ml; or * invasive measurement of left ventricular end-diastolic pressure (LVEDP) \>18 mmHg or of pulmonary artery occluding pressure (wedge pressure) \>16 mmHg. 2. The patient has a prior documentation of impaired left ventricular systolic function (left ventricular ejection fraction \<40%) at most recent assessment by any imaging modality (within 12 months). 3. The patient is symptomatic for moderate to severe dyspnea at time of enrollment as indicated by a score on the visual analog scale for dyspnea of 40 or more (in a scale of 1 to 100, where 0 is no shortness of breath and 100 is extremely short of breath) in the prior 12 hours. 4. The patient has recently received (past 24 hours) or is scheduled to received intravenous loop diuretics. 5. The patient is of age ≥21 years old, willing and able to provide written informed consent and to comply with the protocol (i.e., reporting of symptoms). 6. The patient has screening plasma C-reactive protein levels \>3 mg/L (0.3 mg/dL). 7. Males and females of childbearing potential must use effective contraception.	1. The primary diagnosis for admission is NOT decompensated heart failure, including diagnosis of acute coronary syndromes, hypertensive urgency/emergency, tachy- or brady-arrhythmias. 2. Concomitant clinically significant comorbidities that would interfere with the execution or interpretation of the study including but not limited to acute coronary syndromes; uncontrolled hypertension or orthostatic hypotension; tachy- or brady-arrhythmias; acute or chronic pulmonary disease; or neuromuscular disorders affecting respiration. 3. Recent (previous 3 months) or planned cardiac resynchronization therapy (CRT) or valve surgeries. 4. Previous or planned implantation of left ventricular assist devices or heart transplant. 5. Current or planned use of intravenous inotropes. 6. Recent (\<14 days) use of immunosuppressive or anti-inflammatory drugs (including oral corticosteroids at a prednisone equivalent dose of ≥0.5 mg/kg/day but not including inhaled or low-dose oral corticosteroids, non-steroidal anti-inflammatory drugs or colchicine). 7. Chronic inflammatory disorder (i.e., rheumatoid arthritis, systemic lupus erythematosus). 8. Active infection (of any type), including chronic/recurrent infectious disease (including hepatitis B virus, hepatitis C virus, and HIV/AIDS) - but excluding HCV+ with undetectable plasma RNA. 9. Active malignancy - excluding carcinoma in situ \[any location\] or localized non-melanoma skin cancer. 10. Any comorbidity limiting survival or ability to complete the study, including end-stage heart failure. 11. Stage V kidney disease or on renal-replacement therapy or renal transplant recipient. 12. Neutropenia (\<1,500/mm3 or \<1,000/mm3 in Black/African-American patients). 13. Pregnancy. 14. Hypersensitivity to IC14 or previous adverse reaction to antibody-based treatments.

Inclusion Criteria

Exclusion Criteria

1. Primary diagnosis for hospitalization is decompensated heart failure established as the finding at admission of both conditions listed below:
1. dyspnea or respiratory distress or tachypnea at rest or with minimal exertion; and
2. evidence of elevated cardiac filling pressure or pulmonary congestion (at least one of the conditions must be met):
* Pulmonary congestion/edema a physical exam OR chest x-ray;
* plasma BNP levels ≥200 pg/ml or N-terminal-proBNP ≥600 pg/ml; or
* invasive measurement of left ventricular end-diastolic pressure (LVEDP) \>18 mmHg or of pulmonary artery occluding pressure (wedge pressure) \>16 mmHg.
2. The patient has a prior documentation of impaired left ventricular systolic function (left ventricular ejection fraction \<40%) at most recent assessment by any imaging modality (within 12 months).
3. The patient is symptomatic for moderate to severe dyspnea at time of enrollment as indicated by a score on the visual analog scale for dyspnea of 40 or more (in a scale of 1 to 100, where 0 is no shortness of breath and 100 is extremely short of breath) in the prior 12 hours.
4. The patient has recently received (past 24 hours) or is scheduled to received intravenous loop diuretics.
5. The patient is of age ≥21 years old, willing and able to provide written informed consent and to comply with the protocol (i.e., reporting of symptoms).
6. The patient has screening plasma C-reactive protein levels \>3 mg/L (0.3 mg/dL).
7. Males and females of childbearing potential must use effective contraception.

1. The primary diagnosis for admission is NOT decompensated heart failure, including diagnosis of acute coronary syndromes, hypertensive urgency/emergency, tachy- or brady-arrhythmias.
2. Concomitant clinically significant comorbidities that would interfere with the execution or interpretation of the study including but not limited to acute coronary syndromes; uncontrolled hypertension or orthostatic hypotension; tachy- or brady-arrhythmias; acute or chronic pulmonary disease; or neuromuscular disorders affecting respiration.
3. Recent (previous 3 months) or planned cardiac resynchronization therapy (CRT) or valve surgeries.
4. Previous or planned implantation of left ventricular assist devices or heart transplant.
5. Current or planned use of intravenous inotropes.
6. Recent (\<14 days) use of immunosuppressive or anti-inflammatory drugs (including oral corticosteroids at a prednisone equivalent dose of ≥0.5 mg/kg/day but not including inhaled or low-dose oral corticosteroids, non-steroidal anti-inflammatory drugs or colchicine).
7. Chronic inflammatory disorder (i.e., rheumatoid arthritis, systemic lupus erythematosus).
8. Active infection (of any type), including chronic/recurrent infectious disease (including hepatitis B virus, hepatitis C virus, and HIV/AIDS) - but excluding HCV+ with undetectable plasma RNA.
9. Active malignancy - excluding carcinoma in situ \[any location\] or localized non-melanoma skin cancer.
10. Any comorbidity limiting survival or ability to complete the study, including end-stage heart failure.
11. Stage V kidney disease or on renal-replacement therapy or renal transplant recipient.
12. Neutropenia (\<1,500/mm3 or \<1,000/mm3 in Black/African-American patients).
13. Pregnancy.
14. Hypersensitivity to IC14 or previous adverse reaction to antibody-based treatments.

Contacts and Locations

Principal Investigator

Antonio Abbate, MD

PRINCIPAL_INVESTIGATOR

University of Virginia

Study Locations (Sites)

University of Virginia

Charlottesville, Virginia, 22908

United States

Virginia Commonwealth University

Richmond, Virginia, 23298

United States

Collaborators and Investigators

Sponsor: Implicit Bioscience

Antonio Abbate, MD, PRINCIPAL_INVESTIGATOR, University of Virginia

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-17

Study Completion Date2026-01-31

Study Record Updates

Study Start Date2024-10-17

Study Completion Date2026-01-31

Terms related to this study

Keywords Provided by Researchers

Acute Decompensated Heart Failure
Congestive Heart Failure
Left Heart Failure
Heart Failure

Additional Relevant MeSH Terms

Acute Decompensated Heart Failure