Phase 2
N=31
Interleukin-1 Blockade in HF With Preserved EF
Heart Failure With Normal Ejection Fraction
Bottom Line
View on ClinicalTrials.gov: NCT02173548 ↗Enrolled (actual)
31
Serious AEs
6.7%
Results posted
Jun 2018
Primary outcome: Primary: Change in Aerobic Exercise Capacity — -0.2; 1.0 ml/kg/min
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Anakinra (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Virginia Commonwealth University
- Primary completion
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Aerobic Exercise Capacity |
-0.2; 1.0 | — |
| PRIMARY Change in Ventilatory Eefficiency |
0.2; -0.2 | — |
| SECONDARY Echocardiographic Assessment of Diastolic and Systolic Function (Left Ventricular Ejection Fraction) |
0.3; 1.9 | — |
| SECONDARY Change in Diastolic and Contractile Reserve (e' Velocity and E/e' Ratio) |
-0.7; 0.7 | — |
| SECONDARY Change in Inflammation (C Reactive Protein Levels) |
-2.8; 1.2 | — |
| SECONDARY Change in Quality of Life Questionnaire-Minnesota Living With Heart Failure Questionnaire (MLWHF) |
-6; -16 | — |
| SECONDARY Change in Quality of Life Questionnaire-Duke Activity Status Index (DASI) |
4; 6.5 | — |
| SECONDARY Hospital Admission for Acute Decompensated Heart Failure |
1; 1 | — |
Summary
* 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
Eligibility Criteria
Inclusion Criteria
- Symptoms and signs of heart failure (NYHA II-III) and prior hospitalization for heart failure
- Recent Imaging Study ( 50% and Left Ventricular End Diastolic Volume Index (LVEDVI) 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 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
Exclusion Criteria
- Age 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
Data sourced from ClinicalTrials.gov (NCT02173548). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.