IC14 for Treatment of Acute Decompensated Heart Failure

Launched by IMPLICIT BIOSCIENCE · Aug 14, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new drug called atibuclimab (IC14) to see if it can help adults who are hospitalized with acute decompensated heart failure (ADHF), a serious condition where the heart can't pump enough blood, leading to symptoms like shortness of breath. The trial aims to find out if IC14 is safe for patients, how much of the drug stays in their blood, and how it affects their heart health and other related markers in their blood.

To participate, individuals must be at least 21 years old and have been admitted to the hospital for heart failure. They should be experiencing significant shortness of breath and have a history of heart issues, such as a weakened heart function. Participants will receive IC14 through an intravenous (IV) infusion, and will then have follow-up visits to the hospital or clinic for check-ups and tests over the next three months. This trial does not involve a placebo, meaning everyone will receive the active medication. It’s important for potential participants to discuss their overall health with their doctor to see if they meet the criteria for joining the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Patients may be included in the study only if they meet all of the following 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.
• Exclusion Criteria:
• • 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.