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

NCT ID: NCT01936844

Last Updated: 2016-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2015-05-31

Brief Summary

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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Anakinra (short)

Anakinra 100 mg twice daily for the first 3 days followed by 100 mg daily for days 4-14

Group Type: EXPERIMENTAL

Anakinra (high dose)

Intervention Type: DRUG

Anakinra 100 mg daily twice daily for days 1, 2, and 3

Anakinra (standard dose)

Intervention Type: DRUG

Anakinra 100 mg daily for days 4-14

Placebo

Placebo injections twice daily for the first 3 days then once daily for days 4-14.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo twice daily for days 1, 2, and 3

Placebo

Intervention Type: DRUG

Placebo daily for days 4-14

Interventions

Anakinra (high dose)

Anakinra 100 mg daily twice daily for days 1, 2, and 3

Intervention Type: DRUG

Anakinra (standard dose)

Anakinra 100 mg daily for days 4-14

Intervention Type: DRUG

Placebo

Placebo twice daily for days 1, 2, and 3

Intervention Type: DRUG

Placebo

Placebo daily for days 4-14

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

All 5 criteria need to be met for enrollment of the patient in the study

1. Primary diagnosis of acute decompensated heart failure within the last 24 hours as evidenced by both of the following:

1. dyspnea or respiratory distress or tachypnea at rest or with minimal exertion

2. 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.

2. Left ventricular systolic dysfunction (LVEF<40%) during index hospitalization or prior 12 months.

3. Age ≥18 years old

4. Willing and able to provide written informed consent.

5. Screening plasma C-reactive protein levels >5 mg/L.

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), coronary artery revascularization procedures, or heart valve surgeries.

4. Previous or planned implantation of left ventricular assist devices or heart-transplant.

5. Chronic use of intravenous inotropes.

6. Recent (<14 days) use of immunosuppressive or anti-inflammatory drugs (not including Non-Steroidal Anti-Inflammatory Drugs [NSAIDs]).

7. Chronic inflammatory disorder (including but not limited to rheumatoid arthritis, systemic lupus erythematosus).

8. Active infection (of any type);

9. Chronic/recurrent infectious disease (including Hepatitis B virus [HBV], Hepatitis C virus [HCV], and HIV/AIDS).

10. Prior (within the past 10 years) or current malignancy.

11. Any comorbidity limiting survival or ability to complete the study.

12. End stage kidney disease requiring renal replacement therapy.

13. Neutropenia (<2,000/mm3) or Thrombocytopenia (<50,000/mm3).

14. Pregnancy.

15. Angina, arrhythmias, or electrocardiograph (ECG) changes that limit maximum exertion during cardiopulmonary exercise testing obtained during the baseline testing.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Heart Association

OTHER

Sponsor Role: collaborator

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Benjamin W Van Tassell, PharmD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Virginia Commonwealth University

Richmond, Virginia, United States

Countries

United States

Other Identifiers

VCU HM15347

Identifier Type: -

Identifier Source: org_study_id