Trial · NCT03797001
Interleukin-1 Blockade In Recently Decompensated Heart Failure - 2
NCT03797001, Phase 2, Completed, Virginia Commonwealth University; results first posted 2025-08-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Interleukin-1 Blockade In Recently Decompensated Heart Failure - 2. Trials, record NCT03797001. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03797001
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Interleukin-1 Blockade In Recently Decompensated Heart Failure - 2
- NCT number
- NCT03797001
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 102 participants, actual
- Lead sponsor
- Virginia Commonwealth University
- Conditions
- Heart Failure, Systolic, Inflammation
- Interventions
- Anakinra, Placebo
- First posted
- 2019-01-08
- Last updated
- 2025-08-06
- Results first posted
- 2025-08-06
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Changes in Peak Oxygen Consumption (VO2) | baseline - 24 weeks | changes in peak oxygen consumption (VO2) after 24 weeks of treatment |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Changes in Peak Oxygen Consumption (VO2) | baseline - 24 weeks | patients with data available for primary outcome analysis | mL/kg/min | MEDIAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Changes in Peak Oxygen Consumption (VO2) | Anakinra | 1.50 | Inter-Quartile Range -0.15 to 3.35 | mL/kg/min | |
| Changes in Peak Oxygen Consumption (VO2) | Placebo | 1.20 | Inter-Quartile Range 0.5 to 3.9 | mL/kg/min |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Anakinra | 68 | |
| Overall Study | STARTED | Placebo | 34 | |
| Overall Study | COMPLETED | Anakinra | 57 | |
| Overall Study | COMPLETED | Placebo | 27 | |
| Overall Study | NOT COMPLETED | Anakinra | 11 | |
| Overall Study | NOT COMPLETED | Placebo | 7 |
Source ClinicalTrials.gov
Adverse events8
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Infection requiring antibiotic | Infections and infestations | Anakinra | 11 | 68 | |
| other | Infection requiring antibiotic | Infections and infestations | Placebo | 7 | 34 | |
| serious | Death | Cardiac disorders | Anakinra | 0 | 68 | |
| serious | Death | Cardiac disorders | Placebo | 1 | 34 | |
| serious | Heart failure hospitalization | Cardiac disorders | Anakinra | 6 | 68 | |
| serious | Heart failure hospitalization | Cardiac disorders | Placebo | 3 | 34 | |
| serious | Any hospitalization | General disorders | Anakinra | 12 | 68 | |
| serious | Any hospitalization | General disorders | Placebo | 6 | 34 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Anakinra | 0 | 68 |
| Total, all-cause mortality | Placebo | 1 | 34 |
| Total, other adverse events | Anakinra | 11 | 68 |
| Total, other adverse events | Placebo | 7 | 34 |
| Total, serious adverse events | Anakinra | 12 | 68 |
| Total, serious adverse events | Placebo | 6 | 34 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Anakinra vs Placebo: deaths from any cause | Trial comparisons |
| Anakinra vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03797001
GET https://conductscience.org/api/trials/v1/NCT03797001/registered