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

NCT01542502 | Completed Results

• 1 other identifier: HM14079
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Keywords

Heart failure with preserved ejection fraction; Diastolic heart failure; Aerobic exercise performance

Outcome Measures

Primary Outcomes (1)

• Peak Oxygen Consumption (Peak VO2)

  The primary endpoint is the change in peak oxygen consumption among stable heart failure patients (n = 12) following 14-days treatment with daily doses of Anakinra 100 mg (SC, subcutaneous).

  14 days

Secondary Outcomes (1)

• Exercise Time

  14 days

Other Outcomes (5)

• Correlation Between Endpoints

  28 days

• Heart Failure Symptoms (DASI)

  28 days

• Adverse Events

  28 days

Study Arms (2)

Anakinra

EXPERIMENTAL

Treatment with daily subcutaneous injections of Anakinra 100 mg

Drug: Anakinra

Placebo

PLACEBO COMPARATOR

Treatment with daily subcutaneous injection of placebo

Drug: Placebo

Interventions

Anakinra DRUG

Anakinra 100 mg daily subcutaneous injection

Also known as: Recombinant human Interleukin-1 receptor antagonist, Kineret

Anakinra

Placebo DRUG

Placebo daily subcutaneous injection

Also known as: Sodium Chloride (NaCl) 0.9%

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Invasive Hemodynamic measurements
• mean Pulmonary Capillary Wedge pressure (mPCW) \>12
• Left Ventricular End Diastolic Pressure (LVEDP) \>16 mmHg
• 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)
• Biomarkers
• Brain Natriuretic Peptide (BNP) \>200pg/mL

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• American Heart Association: collaborator

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Heart Failure; Heart Failure, Diastolic

Interventions

Interleukin 1 Receptor Antagonist Protein; Sodium Chloride

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

This is a pilot study to estimate the effects of targeted anti-inflammatory treatment on aerobic exercise capacity in patients with Heart Failure and Preserved Ejection Fraction. All findings should therefore be considered hypothesis generating.

Results Point of Contact

• Title: Antonio Abbate
• Organization: Virginia Commonwealth University

aabbate@vcu.edu

804-828-0513

Study Officials

• Antonio Abbate, MD, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2012
• First Posted: March 2, 2012
• Study Start: February 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: February 6, 2017
• Results First Posted: April 7, 2016

Record last verified: 2016-12

Locations

US (1)