Acute Decompensated Heart FailurePhase 2CopaxoneNCT06003972
Asses the Anti-inflammatory Effects of Short Term Copaxone Therapy on Patients the Acute Decompensated Heart Failure
A Phase 2 study testing Copaxone and guideline directed medical therapy (GDMT) in people with Acute Decompensated Heart Failure and Cytokine Storm, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
Assess the anti-inflammatory effects of short-term Copaxone therapy on patients with acute decompensated heart failure. Trial Design An open-label, randomized, prospective trial of patients hospitalized due to acute decompensation of heart failure with reduced ejection fraction. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Decompensated Heart Failure, Cytokine Storm, Inflammatory Response
- What is being tested?
- Copaxone and guideline directed medical therapy (GDMT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteIsrael
- Study dates
- 4 Jan 2021to 12 Mar 2023
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- STAGE CHF BASELINE NYHA functional class II-III and established diagnosis of ischemic cardiomyopathy
- Hospitalization due to acute decompensated CHF
- GDMT for at least 3 months prior to enrollment
Who cannot join
- Current hospitalization:
- Hemodynamic instability necessitating inotropic or mechanical circulatory support
- Respiratory failure necessitating invasive mechanical ventilation
- Active infection
- A different etiology to explain SIRS other than CHF exacerbation.
- Prior hospitalizations or need of intravenous diuretic therapy in the last 30 days before current hospitalization
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- Cardiac co-morbidities:
- Specific HF etiologies:
- Pericardial disease
- Infiltrative myocardial disease
- Moderate and above Valvular heart disease Acute coronary syndrome in the preceding 60 days to randomization Evidence of significant cardiac ischemia within 1 year of randomization without revascularization since Stroke or TIA in the preceding 30 days from randomization
- Complex congenital cardiac defect
- New initiation of cardiac resynchronization therapy within 60 days prior to randomization
- Life threatening arrhythmias /ICD ACTIVATION- in last 90 days Listing for heart transplantation or anticipated/implanted ventricular assist device
- Non-cardiac co-morbidities:
- Glomerular filtration rate <30 mL/min/1.73m2 calculated by MDRD formula
- Hepatic insufficiency classified as Child-Pugh B or C
- SBP >180 mm Hg or <110 mm Hg NOT RESPONSIVE TO THERAPY
- Morbid obesity with a BMI >40 kg/m2
- Severe pulmonary disease with requirement of home oxygen therapy or important nocturnal desaturation
- Active treatment for malignancy in the past 2 years or neoplastic spread beyond organ of origin (lymphatic metastases included)
- Hemoglobin <8 g/dL
- Known previous systemic inflammatory disease
- Alcohol or drug abuse Chronic treatment with Copaxone, cytotoxic, immunosuppressant or biological treatment in the past two years.
- Known Pregnancy Incapability of signing IC due to cognitive or mental reason Poor compliance to medical therapy or inability to complete the study Age >80 years
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hadassah Ein Kerem medical center-hospital ,Cardiology Department
Jerusalem, 911002
About this study
Assess the anti-inflammatory effects of short-term Copaxone therapy on patients with acute decompensated heart failure.
Trial Design
- An open-label, randomized, prospective trial of patients hospitalized due to acute decompensation of heart failure with reduced ejection fraction.
- Patients will be enrolled within 24 hours from hospital admission.
- Randomization and intervention will begin within 24 hours of enrollment (and at least 24 hours after admission).
- Patients will be randomized in a 1:1 ratio either to receive guideline directed medical therapy (GDMT) or GDMT plus Copaxone.
- Patients assigned to intervention group will receive daily SC Copaxone 20 mg for 14 days.
- Patients will be assessed during 4 time points(screening/randomization, visit 3 day, visit 14 day, visit 30 day) as elaborated in article "monitoring".
- Changes in inflammatory cytokines will be compared between control and intervention group throughout 3 time points.
- The trial will be approved by the institutional view board and conducted in accordance with the principles or Good Clinical Practice guidelines and the Declaration of Helsinki.
- Being tested
- Copaxone, guideline directed medical therapy (GDMT)
- Medical subject headings
- Cytokine Release Syndrome, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CopaxoneDrug
Also called Glatiramer Acetate
Paptients allocated to this arm receive 20 mg GA given s.c daily for a total of 14 days
guideline directed medical therapy (GDMT)Drug
GDMT for heart failure according to the AHA guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | This arm serves as the control arm, patients allocated receive guideline directed medical therapy only Receives: Drug: guideline directed medical therapy (GDMT) |
| Copaxone arm | Experimental | Patients receive guideline directed medical therapy with an add-on GA therapy for 14 days Receives: Drug: Copaxone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoint
%change in inflammatory cytokines from baseline to Day 3 and 2 weeks (up to 3 weeks), compared between intervention vs. control groups
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start4 Jan 2021
- Primary completion12 Mar 2023
- Study completion12 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Decompensated Heart FailureStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Collaborators
- Weizmann Institute of Science
- Responsible party
- Principal investigator, RABEA ASLEH, Hadassah Medical Organization
- Investigators
- Offer Amir, PhD, Study director, Hadassah Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06003972
- Sponsor's protocol ID
- 093418-HMO-CTIL
- Acronym
- Copaxone
- Status last verified
- Aug 2023
- First submitted
- 15 Aug 2023
- Last updated
- 22 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asses the Anti-inflammatory Effects of Short Term Copaxone Therapy on Patients the Acute Decompensated Heart Failure
- ClinicalTrials.gov ID
- NCT06003972
- Acronym / sponsor ID
- Copaxone / 093418-HMO-CTIL
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Collaborators
- Weizmann Institute of Science
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 12 Mar 2023 (actual)
- Study completion
- 12 Mar 2023 (actual)
- First posted
- 22 Aug 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.
Assess the anti-inflammatory effects of short-term Copaxone therapy on patients with acute decompensated heart failure.
Trial Design
- An open-label, randomized, prospective trial of patients hospitalized due to acute decompensation of heart failure with reduced ejection fraction.
- Patients will be enrolled within 24 hours from hospital admission.
- Randomization and intervention will begin within 24 hours of enrollment (and at least 24 hours after admission).
- Patients will be randomized in a 1:1 ratio either to receive guideline directed medical therapy (GDMT) or GDMT plus Copaxone.
- Patients assigned to intervention group will receive daily SC Copaxone 20 mg for 14 days.
- Patients will be assessed during 4 time points(screening/randomization, visit 3 day, visit 14 day, visit 30 day) as elaborated in article "monitoring".
- Changes in inflammatory cytokines will be compared between control and intervention group throughout 3 time points.
- The trial will be approved by the institutional view board and conducted in accordance with the principles or Good Clinical Practice guidelines and the Declaration of Helsinki.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Drug: guideline directed medical therapy (GDMT)This arm serves as the control arm, patients allocated receive guideline directed medical therapy only |
| Copaxone arm | Experimental | Drug: CopaxonePatients receive guideline directed medical therapy with an add-on GA therapy for 14 days |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- STAGE CHF BASELINE NYHA functional class II-III and established diagnosis of ischemic cardiomyopathy
- Hospitalization due to acute decompensated CHF
- GDMT for at least 3 months prior to enrollment
Key exclusion criteria (25 listed)
- Current hospitalization:
- Hemodynamic instability necessitating inotropic or mechanical circulatory support
- Respiratory failure necessitating invasive mechanical ventilation
- Active infection
- A different etiology to explain SIRS other than CHF exacerbation.
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 |
|---|---|---|
| CopaxoneAlso: Glatiramer AcetatePaptients allocated to this arm receive 20 mg GA given s.c daily for a total of 14 days | Drug | Copaxone arm |
| guideline directed medical therapy (GDMT)GDMT for heart failure according to the AHA guidelines. | Drug | Control |
Primary outcome
Primary Endpoint
Time frame: 3 weeks
%change in inflammatory cytokines from baseline to Day 3 and 2 weeks (up to 3 weeks), compared between intervention vs. control groups
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 22 Aug 2023.
- Individual participant dataSharing planned: Yes
Related trials for Acute Decompensated Heart Failure
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Effects of Continued Administration of Empagliflozin in Patients With Heart Failure on Active SGLT2 Inhibitor Treatment Admitted for Acute Decompensated Heart Failure
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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.
Offer Amir, PhD study director
Hadassah Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Copaxone and guideline directed medical therapy (GDMT) in people with Acute Decompensated Heart Failure and Cytokine Storm, run by Hadassah Medical Organization at 1 site in Israel.
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 3 inclusion and 25 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 Aug 2023. 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 Israel. 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 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 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?
Primary Endpoint (time frame: 3 weeks). 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 22 Aug 2023.