Pilot Feasibility Study of the Safety and Efficacy of Anakinra in Heart Failure With Preserved Ejection Fraction

NCT ID: NCT01542502

Last Updated: 2017-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2013-06-30

Brief Summary

This will be a randomized, double-blind, crossover pilot study to measure the safety and feasibility of Interleukin-1 (IL-1) blockade with Anakinra in patients with stable heart failure with preserved ejection fraction.

Conditions

Heart Failure

Study Design

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

Study Groups

Anakinra

Treatment with daily subcutaneous injections of Anakinra 100 mg

Group Type: EXPERIMENTAL

Anakinra

Intervention Type: DRUG

Anakinra 100 mg daily subcutaneous injection

Placebo

Treatment with daily subcutaneous injection of placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo daily subcutaneous injection

Interventions

Anakinra

Anakinra 100 mg daily subcutaneous injection

Intervention Type: DRUG

Placebo

Placebo daily subcutaneous injection

Intervention Type: DRUG

Other Intervention Names

Recombinant human Interleukin-1 receptor antagonist; Kineret; Sodium Chloride (NaCl) 0.9%

Eligibility Criteria

Inclusion Criteria

• Symptoms and signs of congestive heart failure
• Recent Imaging Study (<12 months) showing Left Ventricular Ejection Fraction (LVEF) >50% and Left Ventricular End Diastolic Volume Index (LVEDVI) <97ml/m2
• Evidence of abnormal Left Ventricular (LV) relaxation, filling, diastolic distensibility, and diastolic stiffness as shown by one of the following:

1. Invasive Hemodynamic measurements

• mean Pulmonary Capillary Wedge pressure (mPCW) >12
• Left Ventricular End Diastolic Pressure (LVEDP) >16 mmHg

2. Tissue Doppler Echocardiogram

• E/E' >15
• E/E' 8-15 and one of the following

• Left Ventricular Hypertrophy (LVH)
• Atrial Fibrillation
• Left Atrial Enlargement
• E/A <0.5 + Deceleration Time (DT) >280 (if >50yrs of age)

3. Biomarkers

• Brain Natriuretic Peptide (BNP) >200pg/mL

Exclusion Criteria

• Age <18
• Recent changes (previous 3 months) in HF maintenance medications (beta-blockers, angiotensin converting enzyme [ACE] inhibitors, aldosterone antagonists, vasodilators, cardiac glycosides, diuretics)
• Hospitalization for worsening Heart Failure (HF) or acute decompensated HF within the previous 12months
• Anticipated need for cardiac resynchronization therapy (CRT) or automated-implantable cardioverter defibrillator (AICD)
• Angina or electrocardiograph (ECG) changes that limit maximum exertion during cardiopulmonary exercise testing
• Active infection including chronic infection
• Active cancer
• Recent (<14 days) use of anti-inflammatory drugs (not including Non-Steroidal Anti-Inflammatory Drugs [NSAIDs]), Chronic inflammatory disorder (including but not limited to rheumatoid arthritis, systemic lupus erythematosus), malignancy, or any comorbidity limiting survival or ability to complete the study
• Pregnancy (determined by urine pregnancy test in women of childbearing potential)
• Inability to give informed consent
• Other conditions limiting completion of cardiopulmonary exercise test or completion of the study

• Minimum Eligible Age: 18 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

Antonio Abbate, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Virginia Commonwealth University

Richmond, Virginia, United States

Countries

United States

Other Identifiers

HM14079

Identifier Type: -

Identifier Source: org_study_id