Heart FailurePhase 2/3NCT01936844
Interleukin (IL)-1 Blockade in Acute Heart Failure (Anakinra ADHF)
A Phase 2/3 study testing Anakinra (high dose) and Anakinra (standard dose) in people with Heart Failure, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
Anakinra ADHF is a double-blind randomized clinical trial of anakinra, recombinant human interleukin-1 receptor blocker, or placebo in patients with acute decompensated heart failure with the aim to quench the acute inflammatory response, as measured by the area-under-the-curve for C reactive protein over 14 days. Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Anakinra (high dose) and Anakinra (standard dose)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to May 2015
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All 5 criteria need to be met for enrollment of the patient in the study
- Primary diagnosis of acute decompensated heart failure within the last 24 hours as evidenced by both of the following:
- dyspnea or respiratory distress or tachypnea at rest or with minimal exertion
- evidence of elevated cardiac filling pressure or pulmonary congestion (at least one of the conditions must be met);
- pulmonary congestion/edema at physical exam OR chest x-ray; ii. plasma Brain Natriuretic Peptide (BNP) levels ≥200 pg/mL; iii.invasive measurement of left ventricular end-diastolic pressure >18 mmHg or of pulmonary artery occluding pressure (wedge) >16 mmHg.
- Left ventricular systolic dysfunction (LVEF<40%) during index hospitalization or prior 12 months.
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- Age ≥18 years old
- Willing and able to provide written informed consent.
- Screening plasma C-reactive protein levels >5 mg/L.
- Exclusion Criteria Subjects will not be eligible if they meet any of the following 15 exclusion criteria.
- The primary diagnosis for admission is NOT decompensated heart failure, including diagnosis of acute coronary syndromes, hypertensive urgency/emergency, tachy- or brady-arrhythmias.
- Concomitant clinically significant comorbidities that would interfere with the execution or interpretation of the study including but not limited to acute coronary syndromes, uncontrolled hypertension or orthostatic hypotension, tachy- or brady-arrhythmias, acute or chronic pulmonary disease or neuromuscular disorders affecting respiration.
- Recent (previous 3 months) or planned cardiac resynchronization therapy (CRT), coronary artery revascularization procedures, or heart valve surgeries.
- Previous or planned implantation of left ventricular assist devices or heart-transplant.
- Chronic use of intravenous inotropes.
- Recent (<14 days) use of immunosuppressive or anti-inflammatory drugs (not including Non-Steroidal Anti-Inflammatory Drugs [NSAIDs]).
- Chronic inflammatory disorder (including but not limited to rheumatoid arthritis, systemic lupus erythematosus).
- Active infection (of any type);
- Chronic/recurrent infectious disease (including Hepatitis B virus [HBV], Hepatitis C virus [HCV], and HIV/AIDS).
- Prior (within the past 10 years) or current malignancy.
- Any comorbidity limiting survival or ability to complete the study.
- End stage kidney disease requiring renal replacement therapy.
- Neutropenia (<2,000/mm3) or Thrombocytopenia (<50,000/mm3).
- Pregnancy.
- Angina, arrhythmias, or electrocardiograph (ECG) changes that limit maximum exertion during cardiopulmonary exercise testing obtained during the baseline testing.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: Interleukin-1 Blockade in Acute Decompensated Heart Failure
Anakinra ADHF is a double-blind randomized clinical trial of anakinra, recombinant human interleukin-1 receptor blocker, or placebo in patients with acute decompensated heart failure with the aim to quench the acute inflammatory response, as measured by the area-under-the-curve for C reactive protein over 14 days.
- Conditions
- Heart Failure
- Being tested
- Anakinra (high dose), Anakinra (standard dose), Placebo
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anakinra (high dose)Drug
Anakinra 100 mg daily twice daily for days 1, 2, and 3
Anakinra (standard dose)Drug
Anakinra 100 mg daily for days 4-14
PlaceboDrug
Placebo twice daily for days 1, 2, and 3
PlaceboDrug
Placebo daily for days 4-14
| Study group | Role | What they receive |
|---|---|---|
| Anakinra (short) | Experimental | Anakinra 100 mg twice daily for the first 3 days followed by 100 mg daily for days 4-14 Receives: Drug: Anakinra (high dose); Drug: Anakinra (standard dose) |
| Placebo | Placebo comparator | Placebo injections twice daily for the first 3 days then once daily for days 4-14. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
C Reactive Protein
The proportional area-under-the-curve for plasma C reactive protein (CRP) levels measured during the first 3 days of admission. The proportion (y-axis) is calculated at each time-point with respect to the baseline CRP. The resultant y-axis is a unitless proportion. The x-axis is listed as "days"
Measured: 3 days
Secondary outcomes (2)
Left Ventricular Ejection Fraction
Change in left ventricular ejection fraction (LVEF) between admission and 14 day follow up. This value is expressed as absolute change in measured LVEF. For example, if baseline LVEF = 20% and 14 day LVEF = 25%, this would be reported as an absolute change of 5%.
Measured: 14 days
Brachial Artery Vasoreactivity
Change in flow mediated vasodilatation (FMD) of the brachial artery. Brachial artery FMD is calculated as the percentage increase in brachial artery diameter with hyperemia (an increase in the quantity of blood flow to a body part) induced relative to the resting brachial artery diameter. Percentage of brachial artery diameter is measured as FMD diameter/basal diameter. The change is FMD is reported as the % change in FMD from baseline to 14 days.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2013 (estimated)
- Study startFeb 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Sponsor
- Investigators
- Benjamin W Van Tassell, PharmD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01936844
- Sponsor's protocol ID
- VCU HM15347
- Status last verified
- Mar 2016
- First submitted
- 3 Sep 2013
- Last updated
- 5 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: Data may be available upon request
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interleukin-1 Blockade in Acute Decompensated Heart Failure
- ClinicalTrials.gov ID
- NCT01936844
- Acronym / sponsor ID
- VCU HM15347
- Conditions
- Heart Failure
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- Feb 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 6 Sep 2013 (estimated)
- Results
- Posted 22 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Anakinra ADHF is a double-blind randomized clinical trial of anakinra, recombinant human interleukin-1 receptor blocker, or placebo in patients with acute decompensated heart failure with the aim to quench the acute inflammatory response, as measured by the area-under-the-curve for C reactive protein over 14 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anakinra (short) | Experimental | Drug: Anakinra (high dose), Drug: Anakinra (standard dose)Anakinra 100 mg twice daily for the first 3 days followed by 100 mg daily for days 4-14 |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo injections twice daily for the first 3 days then once daily for days 4-14. |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- All 5 criteria need to be met for enrollment of the patient in the study
- Primary diagnosis of acute decompensated heart failure within the last 24 hours as evidenced by both of the following:
- Left ventricular systolic dysfunction (LVEF<40%) during index hospitalization or prior 12 months.
- Age ≥18 years old
- Willing and able to provide written informed consent.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anakinra (high dose)Anakinra 100 mg daily twice daily for days 1, 2, and 3 | Drug | Anakinra (short) |
| Anakinra (standard dose)Anakinra 100 mg daily for days 4-14 | Drug | Anakinra (short) |
| PlaceboPlacebo twice daily for days 1, 2, and 3 | Drug | Placebo |
| PlaceboPlacebo daily for days 4-14 | Drug | Placebo |
Primary outcome
C Reactive Protein
Time frame: 3 days
The proportional area-under-the-curve for plasma C reactive protein (CRP) levels measured during the first 3 days of admission. The proportion (y-axis) is calculated at each time-point with respect to the baseline CRP. The resultant y-axis is a unitless proportion. The x-axis is listed as "days"
2 secondary outcomes
Left Ventricular Ejection Fraction
Time frame: 14 days
Brachial Artery Vasoreactivity
Time frame: 14 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Data may be available upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin W Van Tassell, PharmD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Anakinra (high dose) and Anakinra (standard dose) in people with Heart Failure, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
C Reactive Protein (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2016.