Interleukin-1 Blockade in HF With Preserved EF
Completed · Phase 2 · Has a placebo group
Conditions studied: Heart Failure With Normal Ejection Fraction
In brief
* Heart Failure with Preserved Ejection Fraction (HFpEF) is a common form of heart failure * Standard treatment for heart failure, show less than ideal results in HFpEF * Evidence of systemic inflammation is common in all forms of heart failure, including HFpEF * The main hypothesis of this study is that systemic inflammation contributes to heart failure symptoms and exercise limitations in patients with HFpEF * The main objective is to treat patients with HFpEF and evidence of systemic inflammation with an anti-inflammatory drug targeting Interleukin-1 (or placebo) to determine effects on cardiovascular function
Key facts
- Study ID
- NCT02173548
- Run by
- Virginia Commonwealth University
- People needed
- 31
- Starts
- 2014-09-01
- Expected to finish
- 2017-06-01
- Last updated by the study team
- 2018-06-19
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Symptoms and signs of heart failure (NYHA II-III) and prior hospitalization for heart failure
- Recent Imaging Study (<12 months) showing LVEF>50% and Left Ventricular End Diastolic Volume Index (LVEDVI) <97ml/m2
- Evidence of abnormal LV relaxation, filling, diastolic distensibility, and diastolic stiffness as shown by one of the following
- a. Invasive Hemodynamic measurements i. mean Pulmonary Capillary Wedge Pressure (mPCW) >12 ii. Left Ventricular End Diastolic Pressure (LVEDP) >16 mmHg b. Tissue Doppler Echocardiogram i. E/E' >15 ii. E/E' 8-15 and one of the following: Left Ventricular Hypertrophy (LVH), Atrial fibrillation, Left Atrial Enlargement (LAE), E/A <0.5 + DT (Deceleration Time) >280, c. Biomarkers i. Brain Natriuretic Peptide (BNP) >200pg/ml (not due to a concomitant disease such as pulmonary arterial hypertension, pulmonary embolism, acute renal failure, or other)
- CRP > 2.0 mg/L
You may not qualify if…
- Age <21
- Concomitant conditions or treatments which would affect completion of the study or interpretation of the study tests including but not limited to the following conditions:
- physical inability to walk or run on a treadmill
- angina or evidence of spontaneous or inducible ischemia
- uncontrolled arterial hypertension
- atrial fibrillation (or other arrhythmias)
- moderate to severe valvular heart disease
- chronic pulmonary disease
- anemia (Hgb<10 g/dl)
- Angina, uncontrolled hypertension or electrocardiograph (ECG) changes (i.e. ischemia, arrhythmias) that limit maximum exertion during cardiopulmonary exercise testing
- Anticipated need for cardiac resynchronization therapy (CRT) or automated-implantable cardioverter defibrillator (AICD) or coronary revascularization or cardiac surgery
- Active infection including chronic infection
- Active cancer (or prior diagnosis of cancer within the past 10 years)
- Recent (<14 days) or active use of immunosuppressive drugs (including but not limited to high-dose corticosteroids [>1_mg/kg of prednisone equivalent], Tumor Necrosis Factor (TNF)-α blockers, cyclosporine) not including Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) or corticosteroids used for IV dye allergy only)
- Chronic auto-immune or auto-inflammatory disease (including but not limited to rheumatoid arthritis, systemic lupus erythematosus)
- Neutropenia (absolute neutrophil count<1,800/mm3 [or <1,000/mm3 in African-American patients])
- Severe impairment in renal function (estimated glomerular filtration rate <30 ml/kg*min)
- Recent or planned use of vaccination with live attenuated viruses
- Allergy to rubber or latex
- Allergy to products derived from Escherichia coli
- Pregnancy or breastfeeding
- Inability to give informed consent
Where it is running
- Virginia Commonwealth University — Richmond, Virginia, United States
Full record on ClinicalTrials.gov
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