Interleukin (IL)-1 Blockade in Acute Heart Failure (Anakinra ADHF)

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Heart Failure

In brief

Anakinra ADHF is a double-blind randomized clinical trial of anakinra, recombinant human interleukin-1 receptor blocker, or placebo in patients with acute decompensated heart failure with the aim to quench the acute inflammatory response, as measured by the area-under-the-curve for C reactive protein over 14 days.

Key facts

Study ID

NCT01936844

Run by

Virginia Commonwealth University

People needed

30

Starts

2014-02-01

Expected to finish

2015-05-01

Last updated by the study team

2016-05-05

Who can join

Age: 21 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All 5 criteria need to be met for enrollment of the patient in the study
• Primary diagnosis of acute decompensated heart failure within the last 24 hours as evidenced by both of the following:
• dyspnea or respiratory distress or tachypnea at rest or with minimal exertion
• evidence of elevated cardiac filling pressure or pulmonary congestion (at least one of the conditions must be met);
• i. pulmonary congestion/edema at physical exam OR chest x-ray; ii. plasma Brain Natriuretic Peptide (BNP) levels ≥200 pg/mL; iii.invasive measurement of left ventricular end-diastolic pressure >18 mmHg or of pulmonary artery occluding pressure (wedge) >16 mmHg.
• Left ventricular systolic dysfunction (LVEF<40%) during index hospitalization or prior 12 months.
• Age ≥18 years old
• Willing and able to provide written informed consent.
• Screening plasma C-reactive protein levels >5 mg/L.
• Exclusion Criteria Subjects will not be eligible if they meet any of the following 15 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), coronary artery revascularization procedures, or heart valve surgeries.
• Previous or planned implantation of left ventricular assist devices or heart-transplant.
• Chronic use of intravenous inotropes.
• Recent (<14 days) use of immunosuppressive or anti-inflammatory drugs (not including Non-Steroidal Anti-Inflammatory Drugs [NSAIDs]).
• Chronic inflammatory disorder (including but not limited to rheumatoid arthritis, systemic lupus erythematosus).
• Active infection (of any type);
• Chronic/recurrent infectious disease (including Hepatitis B virus [HBV], Hepatitis C virus [HCV], and HIV/AIDS).
• Prior (within the past 10 years) or current malignancy.
• Any comorbidity limiting survival or ability to complete the study.
• End stage kidney disease requiring renal replacement therapy.
• Neutropenia (<2,000/mm3) or Thrombocytopenia (<50,000/mm3).
• Pregnancy.
• Angina, arrhythmias, or electrocardiograph (ECG) changes that limit maximum exertion during cardiopulmonary exercise testing obtained during the baseline testing.

Where it is running

• Virginia Commonwealth University — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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