Heart FailurePhase 2/3RED-HARTNCT01936909
Interleukin-1 Blockade in Recently Decompensated Heart Failure
A Phase 2/3 study testing Anakinra (weeks 1-2) and Anakinra (weeks 3-12) in people with Heart Failure, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
The RED-HART is a randomized double-blinded placebo-controlled study of Anakinra (IL-1 blocker) in patients with recently decompensated heart failure to determine the safety and efficacy in terms of aerobic exercise capacity and ventilatory efficiency measured with a cardiopulmonary exercise test. Read more about this study
- Who is it for?
- Ages 21 to 130 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Anakinra (weeks 1-2) and Anakinra (weeks 3-12)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to 23 Sep 2016
- 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 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All 6 criteria need to be met for enrollment of the patient in the study
- Primary diagnosis for hospitalization is decompensated heart failure established as the finding at admission of all 2 conditions listed below:
- 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;
- plasma Brain Natriuretic Peptide (BNP) levels ≥200 pg/ml;
Show all 31Show fewer
- invasive measurement of left ventricular end-diastolic pressure >18 mmHg or of pulmonary artery occluding pressure (wedge) >16 mmHg.
- The patient has a prior documentation of impaired left ventricular systolic function (ejection fraction <50%) at most recent assessment by any imaging modality (within 12 months).
- The patient is now clinically stable and meets standard criteria for hospital discharge as documented by all the 3 conditions listed below:
- absence of dyspnea or pulmonary congestion/distress at rest;
- absence of pitting edema in the lower extremities, or in any other region;
- stable hemodynamic parameters (blood pressure, heart rate).
- The patient is of age ≥21 years old, and is willing and 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).
- The patient has screening plasma C-reactive protein levels >2 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 Recently Decompensated Heart Failure: A Randomized Placebo-controlled Double-blinded Study
The RED-HART is a randomized double-blinded placebo-controlled study of Anakinra (IL-1 blocker) in patients with recently decompensated heart failure to determine the safety and efficacy in terms of aerobic exercise capacity and ventilatory efficiency measured with a cardiopulmonary exercise test.
- Conditions
- Heart Failure
- Being tested
- Anakinra (weeks 1-2), Anakinra (weeks 3-12), 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 (weeks 1-2)Drug
Anakinra 100 mg daily for weeks 1 and 2
Anakinra (weeks 3-12)Drug
Also called Anakinra 100 mg daily for weeks 3 through 12
PlaceboDrug
Also called Placebo daily for week 1 through 12
| Study group | Role | What they receive |
|---|---|---|
| Anakinra (short) | Experimental | Anakinra 100 mg daily for 2 weeks, followed by placebo for 10 weeks Receives: Drug: Anakinra (weeks 1-2) |
| Anakinra (long) | Experimental | Anakinra 100 mg daily for 12 weeks Receives: Drug: Anakinra (weeks 1-2); Drug: Anakinra (weeks 3-12) |
| Placebo | Placebo comparator | Placebo injections daily for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interval Changes in Peak Oxygen Consumption (VO2)
Interval changes in peak oxygen consumption (VO2) after 2 weeks of anakinra treatment.
Measured: Baseline to 2 weeks
Secondary outcomes (2)
Quality of Life Improvement
The Duke Activity Status Index questionnaire will be completed at enrollment and 12 weeks. The scale ranges from 0 (unable to perform any tasks) to 58.20 (able to perform all tasks). Higher scores represent increased ability to perform daily activities and may be interpreted as improved quality of life.
Measured: 12 weeks
Death or Hospital Admission for Heart Failure
We will monitor survival and hospitalization for heart failure throughout the 24 week follow-up
Measured: 24 weeks
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 completion23 Sep 2016
- Study completion23 Sep 2016
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Antonio Abbate, MD, PhD, Principal investigator, Virginia Commonwealth UniversityBenjamin W Van Tassell, PharmD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01936909
- Sponsor's protocol ID
- RED-HART (HM15339)
- Other IDs
- 1R34HL117026
- Acronym
- RED-HART
- Status last verified
- Nov 2017
- First submitted
- 3 Sep 2013
- Last updated
- 22 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Van Tassell BW, Canada J, Carbone S, Trankle C, Buckley L, Oddi Erdle C, Abouzaki NA, Dixon D, Kadariya D, Christopher S, Schatz A, Regan J, Viscusi M, Del Buono M, Melchior R, Mankad P, Lu J, Sculthorpe R, Biondi-Zoccai G, Lesnefsky E, Arena R, Abbate A. Interleukin-1 Blockade in Recently Decompensated Systolic Heart Failure: Results From REDHART (Recently Decompensated Heart Failure Anakinra Response Trial). Circ Heart Fail. 2017 Nov;10(11):e004373. doi: 10.1161/CIRCHEARTFAILURE.117.004373.
PubMed 29141858
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interleukin-1 Blockade in Recently Decompensated Heart Failure: A Randomized Placebo-controlled Double-blinded Study
- ClinicalTrials.gov ID
- NCT01936909
- Acronym / sponsor ID
- RED-HART / RED-HART (HM15339)
- Conditions
- Heart Failure
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Feb 2014
- Primary completion
- 23 Sep 2016 (actual)
- Study completion
- 23 Sep 2016 (actual)
- First posted
- 6 Sep 2013 (estimated)
- Results
- Posted 22 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The RED-HART is a randomized double-blinded placebo-controlled study of Anakinra (IL-1 blocker) in patients with recently decompensated heart failure to determine the safety and efficacy in terms of aerobic exercise capacity and ventilatory efficiency measured with a cardiopulmonary exercise test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anakinra (short) | Experimental | Drug: Anakinra (weeks 1-2)Anakinra 100 mg daily for 2 weeks, followed by placebo for 10 weeks |
| Anakinra (long) | Experimental | Drug: Anakinra (weeks 1-2), Drug: Anakinra (weeks 3-12)Anakinra 100 mg daily for 12 weeks |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo injections daily for 12 weeks |
Who may qualify
- Ages
- 21 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (31 listed)
- All 6 criteria need to be met for enrollment of the patient in the study
- Primary diagnosis for hospitalization is decompensated heart failure established as the finding at admission of all 2 conditions listed below:
- The patient has a prior documentation of impaired left ventricular systolic function (ejection fraction <50%) at most recent assessment by any imaging modality (within 12 months).
- The patient is now clinically stable and meets standard criteria for hospital discharge as documented by all the 3 conditions listed below:
- The patient is of age ≥21 years old, and is 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 (weeks 1-2)Anakinra 100 mg daily for weeks 1 and 2 | Drug | Anakinra (long), Anakinra (short) |
| Anakinra (weeks 3-12)Also: Anakinra 100 mg daily for weeks 3 through 12 | Drug | Anakinra (long) |
| PlaceboAlso: Placebo daily for week 1 through 12 | Drug | Placebo |
Primary outcome
Interval Changes in Peak Oxygen Consumption (VO2)
Time frame: Baseline to 2 weeks
Interval changes in peak oxygen consumption (VO2) after 2 weeks of anakinra treatment.
2 secondary outcomes
Quality of Life Improvement
Time frame: 12 weeks
Death or Hospital Admission for Heart Failure
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29141858Van Tassell BW, Canada J, Carbone S, Trankle C, Buckley L, Oddi Erdle C, Abouzaki NA, Dixon D, Kadariya D, Christopher S, Schatz A, Regan J, Viscusi M, Del Buono M, Melchior R, Mankad P, Lu J, Sculthorpe R, Biondi-Zoccai G, Lesnefsky E, Arena R, Abbate A. Interleukin-1 Blockade in Recently Decompensated Systolic Heart Failure: Results From REDHART (Recently Decompensated Heart Failure Anakinra Response Trial). Circ Heart Fail. 2017 Nov;10(11):e004373. doi: 10.1161/CIRCHEARTFAILURE.117.004373.
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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.
Antonio Abbate, MD, PhD principal investigator
Virginia Commonwealth University
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 (weeks 1-2) and Anakinra (weeks 3-12) 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 31 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 22 Dec 2017. 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 Dec 2017). 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?
Interval Changes in Peak Oxygen Consumption (VO2) (time frame: Baseline to 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01936909, which also lists 1 linked publication.
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 22 Dec 2017.