Heart FailurePhase 1AID-HEARTNCT06062966
The Effects of IL-1 Blockade on Inotrope Sensitivity in Patients With Heart Failure (AID-HEART)
A Phase 1 study testing Anakinra in people with Heart Failure, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
End-stage heart failure (HF) is a progressive illness with a mortality rate similar to most advanced cancers.Roughly 5% of patients with HF have end-stage disease that is refractory to medical therapy (stage D heart failure). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Anakinra
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2024to 1 Jun 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary diagnosis for the clinic visit is stage D heart failure being on chronic stable dose of inotrope therapy (dobutamine or milrinone for the previous 28 days)
- Prior documentation of impaired left ventricular systolic function (ejection fraction <50%) at most recent assessment by any imaging modality (within 12 months)
- Stable dose of inotrope treatment without a recent hospitalization within the previous month
- Age ≥21 years and willing/able to provide written informed consent
- The patient is willing and able to comply with the protocol (i.e. self administration of the treatment, and exercise protocol).
- Screening plasma C-reactive protein levels >2 mg/L
Who cannot join
- Concomitant clinically significant comorbidities 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 that would interfere with the execution, interpretation, or completion of the study
- Recent (previous 3 months) or planned resynchronization therapy (CRT), or valve surgeries
- Previous or planned implantation of left ventricular assist devices or heart transplant within the next 3 months
- Recent (<14 days) use of immunosuppressive or anti-inflammatory drugs (including oral corticosteroids at a dose of prednisone equivalent of 0.5 mg/kg/day but not including inhaled or low dose oral corticosteroids or non-steroidal anti-inflammatory drugs)
- Chronic inflammatory disorder (including but not limited to rheumatoid arthritis, systemic lupus erythematosus)
- Active infection (of any type), including chronic/recurrent infectious disease (including HBV, HCV, and HIV/AIDS) - but excluding HCV+ with undetectable plasma RNA
Show all 12Show fewer
- Prior (within the past 5 years) or current malignancy on targeted treatment - excluding carcinoma in situ [any location] or localized non-melanoma skin cancer
- Stage V kidney disease or on renal-replacement therapy
- Neutropenia (<1,500/mm3 or <1,000/mm3 in African-American patients)
- Pregnancy or breastfeeding
- Angina, hypertension, arrhythmias, electrocardiograph (ECG) changes, or other non-cardiac limitations that limit 6MWD obtained during the baseline testing
- Hypersensitivity to anakinra or to E. coli derived products
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23284
About this study
End-stage heart failure (HF) is a progressive illness with a mortality rate similar to most advanced cancers.Roughly 5% of patients with HF have end-stage disease that is refractory to medical therapy (stage D heart failure). When patients reach this point in their disease, the only treatments known to prolong life are cardiac transplantation or left ventricular assist devices. In patients who do not qualify for these options, or elect a palliative approach, inotropes are frequently used to improve hemodynamics through an increase in cardiac output and reduction in filling pressures. While inotropes provide profound symptomatic relief, these benefits are accompanied by significant risks of progressive adverse cardiac remodeling, arrhythmias, and sudden death. There is, therefore, an urgent need to develop strategies to reduce the dose or duration of inotrope use in the management of patients with stage D of HF.
Read the detailed description
Heart failure (HF) represents a leading cause of morbidity and mortality worldwide. Despite improvements in treatments and widespread efforts to implement guideline directed medical therapies, a growing population of patients with end-stage HF has limited treatment options to improve their quality and quantity of life. When patients reach this point in their disease, the only treatments known to prolong life are cardiac transplantation or left ventricular assist devices. In patients who do not qualify for these options, intravenous (IV) drugs that directly stimulate increased cardiac output ("inotropes") are frequently used to offer symptomatic relief. Inotropes exert their pharmacologic effects through direct activation of the beta-adrenergic receptors in the heart that increase heart rate and contractility. Unfortunately, however, the relief of symptoms from inotropes is accompanied by dose-dependent increased risks of progressive adverse cardiac remodeling, arrhythmias, and sudden death. There is therefore an urgent need to develop treatments that minimize the dosing requirements for inotropes or improve responsiveness to these agents.
Inflammation has been recognized as a major pathophysiological contributor to HF. Interleukin (IL)-1 is a potent apical inflammatory cytokine that is abundant in HF patients and correlates with disease severity. Preclinical data have shown that IL-1 is sufficient to induce cardiac dysfunction, desensitize beta-adrenergic receptors (impaired responsiveness to inotropes), and reduce exercise capacity. Among the observed effects of IL-1 in these models of HF, the impaired responsiveness to inotropes showed the greatest signal-to-noise ratio, suggesting a large potential effect size for IL-1 blockade to translated to human subjects. In a 12-week pilot clinical trial in stable HF patients not receiving IV inotropes, daily administration of an IL-1 antagonist (anakinra) improved exercise capacity. However, IL-1 blockade has not yet been evaluated in patients with more advanced HF requiring inotrope therapy.
- Conditions
- Heart Failure
- Being tested
- Anakinra
- Keywords
- Inotrope sensitivity, IL-1 Blockade, Subcutaneous (SC), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV, 6 Minute Walk Test (6MWT)
- Medical subject headings
- Heart Failure, Hepatitis B, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnakinraDrug
Anakinra 100 mg SC daily will be administered to sujects on chronic inotrope treatment who are not candidates for transplantation or left ventricular assist device (LVAD).
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Not described Receives: Drug: Anakinra |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent reduction in high-sensitive C-Reactive Protein (hsCRP, a biomarker for IL-1 activity)
Percent reduction in hsCRP (a biomarker for IL-1 activity) at 1 month and 3 months of anakinra treatment.
Measured: Months 1 and 3 of treatment
Secondary outcomes (2)
Change of inotrope dose (over 24 hrs) as a percentage of baseline inotrope dose (over 24 hrs)
Inotrope use increases the risk of morbidity and mortality in patients with stage D HF. We hypothesize that anti-inflammatory treatment with IL-1 blockade (anakinra) will improve sensitivity to inotropes and therefore reduce the dose of inotropes required to alleviate HF symptoms in patients with end stage HF.
Measured: Months 1 and 3 of treatment
Change in exercise capacity will be measured with a 6-minute walk test (6MWT)
The 6-minute walk test (6MWT) is strongly correlated with cardiac output and disease severity and is an independent predictor of HF hospitalizations and mortality.
Measured: Baseline, Months 1 and 3 of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2023
- Study start5 Feb 2024
- Primary completion1 Jun 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a pilot study designed to treat 20 subjects to provide the preliminary data necessary to inform the design of subsequent hypothesis-driven studies.
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Azita Talasaz, Principal investigator, Virginia Coomonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06062966
- Sponsor's protocol ID
- HM20027160
- Acronym
- AID-HEART
- Status last verified
- Sep 2026
- First submitted
- 25 Sep 2023
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of IL-1 Blockade on Inotrope Sensitivity in Patients With Heart Failure (AID-HEART)
- ClinicalTrials.gov ID
- NCT06062966
- Acronym / sponsor ID
- AID-HEART / HM20027160
- Conditions
- Heart Failure
- Keywords
- Inotrope sensitivity, IL-1 Blockade, Subcutaneous (SC), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV, 6 Minute Walk Test (6MWT)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 2 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
End-stage heart failure (HF) is a progressive illness with a mortality rate similar to most advanced cancers.Roughly 5% of patients with HF have end-stage disease that is refractory to medical therapy (stage D heart failure). When patients reach this point in their disease, the only treatments known to prolong life are cardiac transplantation or left ventricular assist devices. In patients who do not qualify for these options, or elect a palliative approach, inotropes are frequently used to improve hemodynamics through an increase in cardiac output and reduction in filling pressures. While inotropes provide profound symptomatic relief, these benefits are accompanied by significant risks of progressive adverse cardiac remodeling, arrhythmias, and sudden death. There is, therefore, an urgent need to develop strategies to reduce the dose or duration of inotrope use in the management of patients with stage D of HF.
Detailed description
Heart failure (HF) represents a leading cause of morbidity and mortality worldwide. Despite improvements in treatments and widespread efforts to implement guideline directed medical therapies, a growing population of patients with end-stage HF has limited treatment options to improve their quality and quantity of life. When patients reach this point in their disease, the only treatments known to prolong life are cardiac transplantation or left ventricular assist devices. In patients who do not qualify for these options, intravenous (IV) drugs that directly stimulate increased cardiac output ("inotropes") are frequently used to offer symptomatic relief. Inotropes exert their pharmacologic effects through direct activation of the beta-adrenergic receptors in the heart that increase heart rate and contractility. Unfortunately, however, the relief of symptoms from inotropes is accompanied by dose-dependent increased risks of progressive adverse cardiac remodeling, arrhythmias, and sudden death. There is therefore an urgent need to develop treatments that minimize the dosing requirements for inotropes or improve responsiveness to these agents.
Inflammation has been recognized as a major pathophysiological contributor to HF. Interleukin (IL)-1 is a potent apical inflammatory cytokine that is abundant in HF patients and correlates with disease severity. Preclinical data have shown that IL-1 is sufficient to induce cardiac dysfunction, desensitize beta-adrenergic receptors (impaired responsiveness to inotropes), and reduce exercise capacity. Among the observed effects of IL-1 in these models of HF, the impaired responsiveness to inotropes showed the greatest signal-to-noise ratio, suggesting a large potential effect size for IL-1 blockade to translated to human subjects. In a 12-week pilot clinical trial in stable HF patients not receiving IV inotropes, daily administration of an IL-1 antagonist (anakinra) improved exercise capacity. However, IL-1 blockade has not yet been evaluated in patients with more advanced HF requiring inotrope therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a pilot study designed to treat 20 subjects to provide the preliminary data necessary to inform the design of subsequent hypothesis-driven studies.
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Drug: Anakinra |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Primary diagnosis for the clinic visit is stage D heart failure being on chronic stable dose of inotrope therapy (dobutamine or milrinone for the previous 28 days)
- Prior documentation of impaired left ventricular systolic function (ejection fraction <50%) at most recent assessment by any imaging modality (within 12 months)
- Stable dose of inotrope treatment without a recent hospitalization within the previous month
- Age ≥21 years and willing/able to provide written informed consent
- The patient is willing and able to comply with the protocol (i.e. self administration of the treatment, and exercise protocol).
Key exclusion criteria (12 listed)
- Concomitant clinically significant comorbidities 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 that would interfere with the execution, interpretation, or completion of the study
- Recent (previous 3 months) or planned resynchronization therapy (CRT), or valve surgeries
- Previous or planned implantation of left ventricular assist devices or heart transplant within the next 3 months
- Recent (<14 days) use of immunosuppressive or anti-inflammatory drugs (including oral corticosteroids at a dose of prednisone equivalent of 0.5 mg/kg/day but not including inhaled or low dose oral corticosteroids or non-steroidal anti-inflammatory drugs)
- Chronic inflammatory disorder (including but not limited to rheumatoid arthritis, systemic lupus erythematosus)
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 |
|---|---|---|
| AnakinraAnakinra 100 mg SC daily will be administered to sujects on chronic inotrope treatment who are not candidates for transplantation or left ventricular assist device (LVAD). | Drug | Treatment arm |
Primary outcome
Percent reduction in high-sensitive C-Reactive Protein (hsCRP, a biomarker for IL-1 activity)
Time frame: Months 1 and 3 of treatment
Percent reduction in hsCRP (a biomarker for IL-1 activity) at 1 month and 3 months of anakinra treatment.
2 secondary outcomes
Change of inotrope dose (over 24 hrs) as a percentage of baseline inotrope dose (over 24 hrs)
Time frame: Months 1 and 3 of treatment
Change in exercise capacity will be measured with a 6-minute walk test (6MWT)
Time frame: Baseline, Months 1 and 3 of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
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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.
Azita Talasaz principal investigator
Virginia Coomonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Anakinra 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 6 inclusion and 12 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 4 Sep 2026. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percent reduction in high-sensitive C-Reactive Protein (hsCRP, a biomarker for IL-1 activity) (time frame: Months 1 and 3 of treatment). 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 4 Sep 2026.