Heart Failure, SystolicPhase 2E-HARTNCT03062176
Interleukin-1 Blockade for the Treatment of Heart Failure in Patients With Advanced Chronic Kidney Disease
A Phase 2 study testing Anakinra in people with Heart Failure, Systolic and Renal Disease, End Stage, run by Virginia Commonwealth University.
Trial summary
Interleukin-1 blockade for the treatment of heart failure in patients with advanced chronic kidney disease (End-stage renal disease and Heart fAilure - Anakinra Remodeling Trial) is a Phase 2, single-arm trial designed to estimate the effect of anakinra, a recombinant human Interleukin-1 (IL-1) receptor antagonist, on… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Systolic, Renal Disease, End Stage, Chronic Kidney Diseases
- What is being tested?
- Anakinra
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 3 Apr 2017to 15 May 2019
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- 18 years or older
- Chronic heart failure
- Left ventricular ejection fraction less than 50%
- C-reactive protein greater than or equal to 2 mg/L
- Maintenance hemodialysis with a biocompatible membrane, acceptable dialysis adequacy (Kt/V > 1.2), and receipt of a stable hemodialysis prescription for at least 4 weeks OR chronic kidney disease stage IV/V (estimated glomerular filtration rate <30 mL/min/1.73m2)
Who cannot join
- Inability to complete maximal cardiopulmonary exercise testing
- Need for urgent or emergent care
- Recent use of immunosuppressant, anti-inflammatory therapies or active rheumatologic disease
- Allergy to rubber, latex, Escherichia coli or anakinra
About this study
Official title: Interleukin-1 Blockade for the Treatment of Heart Failure in Patients With Advanced Chronic Kidney Disease (E-HART)
Interleukin-1 blockade for the treatment of heart failure in patients with advanced chronic kidney disease (End-stage renal disease and Heart fAilure - Anakinra Remodeling Trial) is a Phase 2, single-arm trial designed to estimate the effect of anakinra, a recombinant human Interleukin-1 (IL-1) receptor antagonist, on cardiorespiratory fitness in patients with advanced chronic kidney disease and heart failure.
- Being tested
- Anakinra
- Keywords
- Heart failure, End-stage renal disease, Interleukin-1, Interleukin-1 receptor antagonist, Metabolomics, Lipidomics, Chronic kidney disease
- Medical subject headings
- Heart Failure, Systolic, Kidney Failure, Chronic, Renal Insufficiency, Chronic, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnakinraDrug
Also called Kineret
Anakinra (Kineret)
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment | Experimental | Anakinra (Kineret) Receives: Drug: Anakinra |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak oxygen consumption (PVO2)
Peak oxygen consumption during cardiopulmonary exercise
Measured: 6 months
Secondary outcomes (1)
Heart Failure Hospitalization
Number of participants with a hospitalization for heart failure during the 6 months of treatment
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start3 Apr 2017
- Primary completion15 May 2019
- Study completion15 May 2019
Why it stopped: We screened over 200 patients but were ultimately unable to enroll anyone
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure, SystolicStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin W Van Tassell, PharmD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03062176
- Sponsor's protocol ID
- HM20007618
- Acronym
- E-HART
- Status last verified
- May 2019
- First submitted
- 25 Jan 2017
- Last updated
- 17 May 2019
- 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 17 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interleukin-1 Blockade for the Treatment of Heart Failure in Patients With Advanced Chronic Kidney Disease (E-HART)
- ClinicalTrials.gov ID
- NCT03062176
- Acronym / sponsor ID
- E-HART / HM20007618
- Keywords
- Heart failure, End-stage renal disease, Interleukin-1, Interleukin-1 receptor antagonist, Metabolomics, Lipidomics, Chronic kidney disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We screened over 200 patients but were ultimately unable to enroll anyone
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 3 Apr 2017 (actual)
- Primary completion
- 15 May 2019 (actual)
- Study completion
- 15 May 2019 (actual)
- First posted
- 23 Feb 2017 (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.
Interleukin-1 blockade for the treatment of heart failure in patients with advanced chronic kidney disease (End-stage renal disease and Heart fAilure - Anakinra Remodeling Trial) is a Phase 2, single-arm trial designed to estimate the effect of anakinra, a recombinant human Interleukin-1 (IL-1) receptor antagonist, on cardiorespiratory fitness in patients with advanced chronic kidney disease and heart failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active Treatment | Experimental | Drug: AnakinraAnakinra (Kineret) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Written informed consent
- 18 years or older
- Chronic heart failure
- Left ventricular ejection fraction less than 50%
- C-reactive protein greater than or equal to 2 mg/L
Key exclusion criteria (4 listed)
- Inability to complete maximal cardiopulmonary exercise testing
- Need for urgent or emergent care
- Recent use of immunosuppressant, anti-inflammatory therapies or active rheumatologic disease
- Allergy to rubber, latex, Escherichia coli or anakinra
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 |
|---|---|---|
| AnakinraAlso: KineretAnakinra (Kineret) | Drug | Active Treatment |
Primary outcome
Peak oxygen consumption (PVO2)
Time frame: 6 months
Peak oxygen consumption during cardiopulmonary exercise
1 secondary outcome
Heart Failure Hospitalization
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2019.
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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
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anakinra in people with Heart Failure, Systolic and Renal Disease, End Stage, run by Virginia Commonwealth University.
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 4 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: withdrawn, as of the sponsor's last update on 17 May 2019. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
Peak oxygen consumption (PVO2) (time frame: 6 months). 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 17 May 2019.