A Phase 1/2 interventional study of Anakinra in Heart Failure, sponsored by Virginia Commonwealth University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-11-30.
Sponsored by Virginia Commonwealth University · Phase 1/2, Interventional, and Treatment
This is an open-label, non-randomized, pilot-study to evaluate the effect of Interleukin-1 blockade on exercise capacity in patients with heart failure. Subjects will undergo cardiopulmonary exercise testing at baseline and after 2-weeks treatment with anakinra (recombinant human Interleukin-1 receptor antagonist).
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 11 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Virginia Commonwealth University is the lead sponsor of 641 studies on the registry; 82 are open to participants now.
Of its 88 completed or terminated interventional studies of FDA-regulated products, 62 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Anakinra
Anakinra 100 mg subcutaneous injection daily
Median Interval Change From Baseline in Peak VO2
Peak VO2 is a measurement of oxygen consumption rate during exercise (milliliters of oxygen per minute). It is calculated by continuous measurement of oxygen consumed during exercise while patients breath through a mask/tube. To account for variability in patient size, the oxygen consumption is divided by patient body weight. The outcome measure time frame was 14 days. This means that change in peak VO2 was calculated as the difference between peak VO2 at baseline and 14 days. To calculate this change, we used the mathematical process of subtraction (change in peak VO2 = Peak VO2 \[day 14\] - Peak VO2 \[baseline\])
Time frame: 14 days
Median Interval Change From Baseline in the Minute Ventilation and Carbon Dioxide Production (VE/VCO2 Slope)
The VE/VCO2 slope is calculated as the ratio of minute ventilation (VE) and carbon dioxide production (VCO2). Because these measurements share the same units, the resultant ratio is unitless. Change in VE/VCO2 slope was calculated as the change in VE/VCO2 slope between baseline and 14 days. We therefore calculated the difference between VE/VCO2 slope measurements that occurred at baseline and at 14 days (change in VE/VCO2 slope = VE/VCO2 slope \[day 14\] - VE/VCO2 slope \[baseline\])
Time frame: 14 days
Interval Change From Baseline in Heart Failure Symptoms as Measured by Duke Activity Status Index (DASI)
The Duke Activity Status Index (DASI) is a scale that quantifies patients' ability to perform various tasks. The scale ranges from 0 (unable to perform any tasks) to 58.20 (able to perform all tasks). Higher scores reflect improved activity or improved heart failure symptoms. Lower scores reflect worsened ability or worsened heart failure symptoms.
Time frame: 14 days
Interval Change From Baseline in Biomarkers (High-sensitivity C-reactive Protein, Whole Blood Assay, Brain Natriuretic Peptide)
Time frame: 14 days
Correlation Between Interval Changes in Biomarkers, Peak VO2, and VE/VCO2
Time frame: 14 days
11 patients had elevated hsCRP (\>2 mg/L) and were enrolled in the study.
| Milestone | Anakinra |
|---|---|
| Started | 8 |
| Completed | 7 |
| Not completed | 1 |
| Withdrew: Adverse event | 1 |
Peak VO2 is a measurement of oxygen consumption rate during exercise (milliliters of oxygen per minute). It is calculated by continuous measurement of oxygen consumed during exercise while patients breath through a mask/tube. To account for variability in patient size, the oxygen consumption is divided by patient body weight. The outcome measure time frame was 14 days. This means that change in peak VO2 was calculated as the difference between peak VO2 at baseline and 14 days. To calculate this change, we used the mathematical process of subtraction (change in peak VO2 = Peak VO2 \[day 14\] - Peak VO2 \[baseline\])
| mL/kg/min | Anakinra |
|---|---|
| Median Interval Change From Baseline in Peak VO2 | 3.90 (2.30 to 4.95) |
The VE/VCO2 slope is calculated as the ratio of minute ventilation (VE) and carbon dioxide production (VCO2). Because these measurements share the same units, the resultant ratio is unitless. Change in VE/VCO2 slope was calculated as the change in VE/VCO2 slope between baseline and 14 days. We therefore calculated the difference between VE/VCO2 slope measurements that occurred at baseline and at 14 days (change in VE/VCO2 slope = VE/VCO2 slope \[day 14\] - VE/VCO2 slope \[baseline\])
| (unitless) | Anakinra |
|---|---|
| Median Interval Change From Baseline in the Minute Ventilation and Carbon Dioxide Production (VE/VCO2 Slope) | -2.10 (-4.10 to -0.55) |
The Duke Activity Status Index (DASI) is a scale that quantifies patients' ability to perform various tasks. The scale ranges from 0 (unable to perform any tasks) to 58.20 (able to perform all tasks). Higher scores reflect improved activity or improved heart failure symptoms. Lower scores reflect worsened ability or worsened heart failure symptoms.
| units on a scale | Anakinra |
|---|---|
| Interval Change From Baseline in Heart Failure Symptoms as Measured by Duke Activity Status Index (DASI) | 6 (0 to 20.2) |
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Anakinra | 0/8 (0%) | 0/8 (0%) | 1/8 (12.5%) |
| Event | Anakinra |
|---|---|
| Flu-like symptomsGeneral disorders | 1/8 |
| Age, Categorical(Participants) | Anakinra |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 7 |
| >=65 years | 1 |
| Age, Continuous(years) | Anakinra |
|---|---|
| Mean | 55 ± 11 |
| Sex: Female, Male(Participants) | Anakinra |
|---|---|
| Female | 4 |
| Male | 4 |
| Region of Enrollment(participants) | Anakinra |
|---|---|
| United States | 8 |
This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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Virginia Commonwealth University