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

NCT02317458 | Unknown Phase 3 DMC

• 1 other identifier: C3BS-C-12-01
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (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

  52 weeks

Study Arms (2)

Active arm

EXPERIMENTAL

One arm with standard of care and C3BS-CQR-1 injection (treatment group) using intramyocardial catheter injection.

Biological: Experimental

Control arm

SHAM COMPARATOR

One arm with standard of care undergoing a sham procedure (control group)using intramyocardial catheter injection. .

Biological: Sham comparator

Interventions

Experimental BIOLOGICAL

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

Also known as: C3BR-CQR-1

Active arm

Sham comparator BIOLOGICAL

One arm with standard of care undergoing a sham procedure

Control arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Celyad Oncology SA: lead

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2014
• First Posted: December 16, 2014
• Study Start: June 1, 2017
• Primary Completion: March 1, 2020
• Last Updated: July 11, 2016

Record last verified: 2016-07