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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-001117-13 | EudraCT Number |
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Evaluation the safety and efficacy of C3BS-CQR-1 by comparing the overall response to standard of care and C3BS-CQR-1 relative to standard of care and a sham procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Sham Comparator | Sham, no injection |
|
| C3BS-CQR-1 Treated | Experimental | Injection of C3BS-CQR-1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Injection of C3BS-CQR-1 | Biological | Injection of the C3BS-CQR-1 using the C-Cath® injection catheter. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy between groups post-index procedure | Change between groups from baseline and 39 weeks in a hierarchical composite outcome comprising, from most to least severe outcome, days to death from any cause, number of worsening of heart failure events, change in score for the Minnesota Living with Heart Failure Questionnaire (MLHFQ) (10-point deterioration, no meaningful change,10-point improvement), change in six-minute walk distance (40-m deterioration, no meaningful change, 40-m improvement) and change in left ventricular end systolic volume (15-mL deterioration, no meaningful change, 15-mL improvement), and left ventricular ejection fraction (4% absolute deterioration, no meaningful change, 4% absolute improvement). | 39 weeks post-index |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy and safety between groups post-index procedure | Safety: Number and cause of deaths and re-admissions, number of cardiac transplantations, number of myocardial infarctions, number of strokes. Incidence of serious adverse events (AE) through week 104 and non-serious AEs (through week 52). Efficacy: Time to all cause mortality, time to worsening of heart failure, and time to aborted sudden death through week 52. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy and safety between groups post-index procedure | Time to all cause mortality, time to cardiovascular mortality, and rate of worsening heart failure requiring outpatient IV therapy for heart failure or readmission for heart failure, and others. | 39 and 52 weeks post-index |
Inclusion Criteria:
Eligible patients must meet all of the following inclusion criteria:
Exclusion Criteria (summarized):
Eligible patients must meet none of the following exclusion criteria:
Women who are pregnant, confirmed by a positive urine or serum human chorionic gonadotropin laboratory test at screening.
Women of child-bearing potential without a negative serum or urine pregnancy test at screening. 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 doublebarrier methods.
Men refusing to exercise a reliable form of contraception.
Myocardial infarction, unstable angina or percutaneous coronary intervention (PCI) within 90 days prior to screening, or coronary artery bypass graft surgery within 180 days prior to screening.
Patient on a cardiac transplant list or previously received any solid organ transplant.
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 placement device more than one year ago.
Patient has undergone cardiac resynchronization therapy within 6 months prior to screening.
Severe uncontrolled HF requiring need for intensive intravenous diuretics or inotropic support within 1 month prior to screening.
Inability to perform a 6 minute walk test due to physical limitations other than HF including:
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 > 45.
Left ventricular thrombus.
Left ventricular (LV) 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 ventricular tachycardia or ventricular fibrillation which led to automatic implantable cardioverter/defibrillator (AICD) therapy (shock) within 3 months prior to screening.
Primary significant organic valvular heart disease.
Moderate to severe aortic valve disease precluding catheter entry into the LV.
Mechanical prosthetic valve in aortic or mitral position.
Chronic infection or active malignancy.
Patient has compromised renal function as reflected by a serum creatinine level >3.0 mg/dL (>0.265 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.
Chronic immunosuppressive therapy due to inflammatory or systemic disease.
Patient tested positive for HIV 1 or 2, Hepatitis B or C, human T-cell lymphotrophic virus (HTLV) 1 or 2 (if required by regulations) or syphilis.
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 congestive heart failure which might reduce life expectancy to less than 2 years from screening.
Known and relevant allergies and/or hypersensitivities to Dextran or other plasma volume expanders to include Gentran, Hyskon and Macrodex.
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| Name | Affiliation | Role |
|---|---|---|
| André Terzic, MD | Mayo Clinic, Division of Cardiovascular Diseases, Rochester (MN, USA) | Study Chair |
| Jozef Bartunek, MD | OLV Ziekenhuis Aalst (Belgium) | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OLV Ziekenhuis Aalst | Aalst | 9300 | Belgium | |||
| Centre Hospitalier Universitaire de Liège |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26662998 | Derived | Bartunek J, Davison B, Sherman W, Povsic T, Henry TD, Gersh B, Metra M, Filippatos G, Hajjar R, Behfar A, Homsy C, Cotter G, Wijns W, Tendera M, Terzic A. Congestive Heart Failure Cardiopoietic Regenerative Therapy (CHART-1) trial design. Eur J Heart Fail. 2016 Feb;18(2):160-8. doi: 10.1002/ejhf.434. Epub 2015 Dec 14. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 20, 2020 | |
| Reset | Mar 6, 2020 | |
| Release | Jun 30, 2020 |
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| Sham, no injection | Biological | Mimic the injection procedure trough insertion of a sham catheter. No injection actually performed |
|
| 52 and 104 weeks post-index |
| Liège |
| 4000 |
| Belgium |
| Hopital Civil Marie Curie | Lodelinsart | 6042 | Belgium |
| AZ Glorieux | Ronse | 9600 | Belgium |
| CHU Mont-Godinne | Yvoir | 5530 | Belgium |
| City Clinic Cardiology Center Multiprofile Hospital for Active Treatment | Sofia | 1407 | Bulgaria |
| Multiprofile Hospital for Active Treatment 'Tokuda Hospital Sofia' | Sofia | 1407 | Bulgaria |
| University Multiprofile Hospital for Active Treatment 'Alexandrovska' EAD | Sofia | 1431 | Bulgaria |
| Gottsegen György Országos Kardiológiai Intézet - Felnőtt Kardiológiai Osztály | Budapest | 1096 | Hungary |
| Semmelweis Egyetem - Városmajori Szív- és Érgyógyászati Klinika | Budapest | 1122 | Hungary |
| MH Egészségügyi Központ Kardiológiai Osztály | Budapest | 1134 | Hungary |
| Debreceni Egyetem Orvos - és Egészségtudomanyi Centrum | Debrecen | 4032 | Hungary |
| Pécsi Tudományegyetem Klinikai Központ - Szívgyógyászati Klinika | Pécs | 7624 | Hungary |
| Barzilai Medical Center - Cardiology Unit | Ashkelon | 78278 | Israel |
| Hillel Yaffe Medical Center | Hadera | 38100 | Israel |
| Western Galilee Hospital | Nahariya | Israel |
| Nazareth Hospital EMMS | Nazareth | 16100 | Israel |
| Ziv Medical Center - Heart Institute | Safed | 13110 | Israel |
| A.O. Spedali Civili di Brescia | Brescia | 25123 | Italy |
| AOUI Verona - Borgo Trento Hospital | Verona | 37126 | Italy |
| Uniwersyteckie Centrum Kliniczne, KliniczneCentrum Kardiologii | Gdansk | 80-126 | Poland |
| Górnośląskie Centrum Medyczne Śląskiej Akademii Medycznej | Katowice | 40-635 | Poland |
| Krakowski Szpital Specjalistyczny im. Jana Pawła II w Krakowie | Krakow | 31-202 | Poland |
| Biegański Hospital | Lodz | 91-347 | Poland |
| Clinic of Emergency Internal Medicinne Military Medical Academy | Belgrade | 11000 | Serbia |
| Clinical Center of Serbia - Cardiology Clinic | Belgrade | 11000 | Serbia |
| Clinical Centre of Serbia, Cardiology Clinic | Belgrade | 11000 | Serbia |
| Clinical Hospital Center Zvezdara - Cardiology Clinic | Belgrade | 11000 | Serbia |
| Clinical Hospital Center Bezanijska Kosa, Cardiology Dept. | Belgrade | 11080 | Serbia |
| Clinical Center of Kragujevac, | Kragujevac | 34 000 | Serbia |
| Hospital Universitario Germans Trias i Pujol | Barcelona | 08916 | Spain |
| Hospital General Universitario Gregorio Marañon | Madrid | 28007 | Spain |
| Hospital Clinico San Carlos | Madrid | 28040 | Spain |
| Hospital Clinico Universitario Virgen de la Victoria - Campus de Teatinos s/n | Málaga | 29010 | Spain |
| Cardiocentro Ticino | Lugano | 6900 | Switzerland |
| Reset | Jul 13, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 20, 2020 | Mar 6, 2020 | |||
| Jun 30, 2020 | Jul 13, 2020 |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C005703 | salicylhydroxamic acid |
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