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Heart FailurePhase 3CHART-2NCT02317458

Congestive Heart Failure Cardiopoietic Regenerative Therapy (CHART-2) Trial - THE CHART-2 TRIAL

A Phase 3 study testing Experimental in people with Heart Failure, run by Celyad Oncology SA.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study is designed to evaluate the efficacy and safety of the C3BS-CQR-1 in the treatment of patients with chronic heart failure secondary to ischemic cardiomyopathy. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Heart Failure
What is being tested?
Experimental
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
400 participants
Where
No sites listed yet
Study dates
Jun 2017to Mar 2020
Phase
Phase 3
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

  • Age ≥ 18 and < 80 years.
  • Systolic dysfunction with LVEF ≤ 35% as assessed by echocardiography.
  • Ischemic heart failure ineligible for further revascularization. Ischemic heart failure is defined as history of myocardial infarction or evidence of clinically significant coronary disease associated with LV systolic dysfunction leading to HF. The patient must not be a candidate for revascularization in the judgment of the investigator, based on the absence of unstable coronary-related symptoms and either non-invasive testing or coronary angiography within 24 months prior to screening.
  • Total MLHFQ score > 30.
  • Ability to perform a Six-Minute Walk Test > 100 m and ≤ 375 m.
  • History of hospitalization for HF within 12 months prior to screening or treatment in an out-patient clinic with intravenous therapy (including vasodilators, positive inotropic agents, vasopressors or diuretics) for worsening HF within 12 months prior to screening. Be or must have been diagnosed within the previous 12 months in NYHA class III or IV or INTERMACS class 4, 5, 6 or 7, and at the time of inclusion, must be at least in NYHA class II or greater. If in NYHA class II, 2 or more HF worsening events or NT-ProBNP > 1000 pg/mL requiring hospitalization or outpatient IV therapy during the prior 12 months are required.
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  • Use of ACE inhibitor and/or ARB or sacubitril/valsartan (Entresto™); and beta blocker, for at least 3 months prior to screening visit, unless intolerant or contraindicated.
  • Stable dosing of ACE inhibitor or ARB or sacubitril/valsartan (Entresto™) and beta blocker, aldosterone blocker, and diuretics for at least one month prior to screening visit, defined as ≤50% change in total dose of each agent.
  • Willing and able to give written informed consent.

Who cannot join

  • Women who are pregnant, confirmed by a positive urine or serum hCG laboratory test at screening.
  • Women of child-bearing potential without a negative serum or urine pregnancy test at screening or who are not practicing a reliable form of birth control. Women who are postmenopausal (12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum FSH level > 40 mIU/mL or 6 weeks post-surgical bilateral oophorectomy) or surgically sterile are not considered to be of child-bearing potential. Reliable contraception includes surgical sterilization, hormonal contraception, or double-barrier methods.
  • Men refusing to exercise a reliable form of contraception unless partner is unable to conceive.
  • Acute coronary syndrome leading to myocardial infarction or unstable angina within 90 days of screening.
  • Percutaneous coronary intervention (PCI) within 90 days prior to screening, or CABG surgery within 180 days prior to screening.
  • Patient on a cardiac transplant list or previously received any solid organ transplant.
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  • Previously underwent cardiac surgery with remodeling procedure, left ventricular assist device placement or cardiomyoplasty. This exclusion does not apply to patients who underwent ventricularplasty without placements device >1 year ago.
  • Patient has undergone cardiac resynchronization therapy (CRT) within 6 months (180 days) prior to screening.
  • Severe uncontrolled HF requiring need for intravenous diuretics or inotropic support within 1 month prior to screening.
  • Inability to perform a Six-Minute Walk Test due to physical limitations other than HF including:
  • Severe peripheral vascular disease
  • Severe pulmonary disease or chronic obstructive pulmonary disease (COPD) with FEV1 <30% predicted
  • Orthopedic limitations, severe muscular diseases, any other joint or muscular disease or neurological disorder (such as an old stroke or neuropathy) limiting the ability to walk for 6 minutes.
  • Dependence on chronic oral steroid therapy.
  • Stroke or transient ischemic attack leading to limitations in lower extremities or occurring within 180 days prior to screening.
  • Active myocarditis, constrictive pericarditis, restrictive, hypertrophic or congenital cardiomyopathy.
  • BMI < 19 or > 40 kg/m2.
  • Left ventricular thrombus.
  • Left ventricular wall thickness < 8mm visualized in more than 50% of LV, and defined as a "LV no-go zone
  • LV aneurysm or candidate for surgical aneurysmectomy.
  • Sustained VT or VF which led to AICD therapy (shock) within 3 months prior to screening.
  • Primary valvular disease of ≥ moderate degree, including mitral or aortic stenosis (with aortic valve area < 1.5 cm2) or regurgitation. Secondary mitral and tricuspid regurgitation due to LV dilatation will not be excluded
  • Prosthetic valve in aortic or mitral position, or prior MitraClip placement.
  • Chronic infection or active malignancy.
  • Compromised renal function as reflected by a serum creatinine level >2,0 mg/dL (>0.177 mmol/l) or is currently on dialysis.
  • Hematocrit < 28%.
  • Atherosclerosis and/or tortuosity of the aorta, iliac or femoral arteries of a degree that could impede or preclude the safe retrograde passage of the delivery catheter, including untreated aneurysm of the aorta.
  • Chronic immunosuppressive therapy due to inflammatory or systemic disease.
  • Patient tested positive for HIV 1 or 2, Hepatitis B or C, HTLV 1 or syphilis (as detailed in Section 19.1).
  • Exposure to any previous experimental cell or angiogenic therapy and/or myocardial laser therapy and/or therapy with another investigational drug within 60 days prior to screening or enrollment in any concurrent study that may confound the results of this study.
  • Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or in the opinion of the investigator are not suitable to participate.
  • Any illness other than CHF which might reduce life expectancy to less than 2 years from screening.
  • Known and relevant allergies and/or hyper-sensitivities to Dextran or other plasma volume expanders (including Gentran, Hyskon and Macrodex), to Bovine Serum Albumin (BSA) or to any albumin from animal origin.
  • Known severe allergy to the cardiac radiological contrast mixture.
  • Required dosage of cardiopoietic cells not reached

About this study

Official title: EFFICACY AND SAFETY OF BONE MARROW-DERIVED MESENCHYMAL CARDIOPOIETIC CELLS (C3BS-CQR-1) FOR THE TREATMENT OF CHRONIC ISCHEMIC HEART FAILURE

This study is designed to evaluate the efficacy and safety of the C3BS-CQR-1 in the treatment of patients with chronic heart failure secondary to ischemic cardiomyopathy.

Read the detailed description

Patients with chronic heart failure secondary to ischemic cardiomyopathy being on standard of care will be screened per the protocol inclusion and exclusion criteria. Enrolled patients will be randomized on a 1:1 ratio to either standard of care and C3BS-CQR-1 injection (treatment group) or standard of care undergoing a sham procedure (control group). Patients randomized to the treatment group, for which C3BS-CQR-1 production met release criteria, will undergo endoventricular injection of the C3BS-CQR-1 using injection catheter.

Conditions
Heart Failure
Being tested
Experimental, Sham comparator
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExperimentalBiological

    Also called C3BR-CQR-1

    One active arm with standard of car and treatment with C3BR-CQR-1 using intramyocardial injection

  • Sham comparatorBiological

    One arm with standard of care undergoing a sham procedure

Study groups in NCT02317458
Study groupRoleWhat they receive
Active armExperimentalOne arm with standard of care and C3BS-CQR-1 injection (treatment group) using intramyocardial catheter injection.
Receives: Biological: Experimental
Control armSham comparatorOne arm with standard of care undergoing a sham procedure (control group)using intramyocardial catheter injection. .
Receives: Biological: Sham comparator

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy of C3BS-CQR-1 injection based on a hierarchical composite score

    1. Died of CV cause
    2. Hospitalized 2 or more times for HF
    3. Hospitalized once for HF
    4. Minnesota Living with Heart Failure Questionnaire (MLHFQ) total score worsened by 10 or more points
    5. MLHFQ total score neither worsened by 10 or more points nor improved by 10 or more points, or died of non-CV cause
    6. MLHFQ total score improved by 10 or more points

    Measured: 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2014 (estimated)
  2. Study startJun 2017
  3. Primary completionMar 2020 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02317458
Sponsor's protocol ID
C3BS-C-12-01
Acronym
CHART-2
Status last verified
Jul 2016
First submitted
9 Dec 2014
Last updated
11 Jul 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Experimental in people with Heart Failure, run by Celyad Oncology SA.

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 9 inclusion and 35 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: status not confirmed, as of the sponsor's last update on 11 Jul 2016. 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. 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 phase mean?

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?

Results are not available in the source record.

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?

Efficacy of C3BS-CQR-1 injection based on a hierarchical composite score (time frame: 52 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 NCT02317458.

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 11 Jul 2016.

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