IC14 for Treatment of Acute Decompensated Heart Failure (NCT06556810) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
IC14 for Treatment of Acute Decompensated Heart Failure
United States10 participantsStarted 2024-10-17
Plain-language summary
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
Who can participate
Age range
21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Primary diagnosis for hospitalization is decompensated heart failure established as the finding at admission of both conditions listed below:
. dyspnea or respiratory distress or tachypnea at rest or with minimal exertion; and
. evidence of elevated cardiac filling pressure or pulmonary congestion (at least one of the conditions must be met):
. 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).
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1/2 trial, what do we actually know so far about whether IC14 is safe for people with acute decompensated heart failure, and how does being in an early-phase study affect the risk I'd be taking on?
2The trial is no longer enrolling new patients — does that mean there's any chance of me still being considered, or should I focus my energy on other options?
3The study is specifically measuring whether people develop anti-drug antibodies against IC14 — can you explain what that means for my health, and whether it could affect my ability to use other treatments down the road?
4Acute decompensated heart failure can be a medical emergency — how would being in this trial affect the standard care I'd normally receive, and would I still get the usual treatments like diuretics or other heart failure medications?
5Given that this trial is still in early phases and is no longer recruiting, what are the current standard-of-care treatments you'd recommend for my situation, and how do they compare to what IC14 is trying to do differently?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. The patient has recently received (past 24 hours) or is scheduled to received intravenous loop diuretics.
. 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).
. The patient has screening plasma C-reactive protein levels \>3 mg/L (0.3 mg/dL).
Exclusion criteria
. The primary diagnosis for admission is NOT decompensated heart failure, including diagnosis of acute coronary syndromes, hypertensive urgency/emergency, tachy- or brady-arrhythmias.
. 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.
. Recent (previous 3 months) or planned cardiac resynchronization therapy (CRT) or valve surgeries.
. Previous or planned implantation of left ventricular assist devices or heart transplant.
. Current or planned use of intravenous inotropes.
. 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).
. 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.