Heart Failure With Reduced Ejection Fraction
Conditions
Brief summary
It´s a first open-label trial in humans to evaluate the safety and efficacy of epicardial delivery of collagen patches with adipose-derived stem cells in patients with ischemic heart disease and left ventricular dysfunction that remain symptomatic despite optimal medical treatment.
Interventions
DEVICEVB-C01
Surgical implant of VB-C01 (Collagen membrane seeded with allogeneic stem cells isolated from adipose tissue, ADSC).
Sponsors
Ministerio de Ciencia e Innovación, Spain
Viscofan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Men and women aged ≥18 years and ≤80 years. * LVEF ≤35% as assessed by echocardiography, confirmed by MRI if there are no contraindications for this procedure. * History of revascularised or nonrevascularisable coronary artery disease as the cause of ventricular dysfunction. * NYHA functional class III for dyspnea under optimal medical treatment. * Ability to perform the exercise test with respiratory gas consumption. MVO2 should be ≥ 10 and ≤ 18 ml/kg/min in the exercise test. * Ability to perform a 6-minute walk test \> 100 m and ≤ 400 m. * Haemodynamic stability (blood pressure \> 100/40 mmHg, heart rate \< 110 bpm and oxygen saturation at rest in room air \> 95%).
Exclusion criteria
* Participation in another clinical trial within 30 days prior to inclusion. * Prior treatment with cell or gene therapy. * Diagnosis of acute myocardial infarction with 3 months prior to inclusion. * Significant coronary artery disease eligible for revascularization. * Significant valvular disease eligible for surgery. * Presence of uncontrolled ventricular arrhythmias (VR or VF) at the time of implant surgery. * Women who are pregnant or breastfeeding. * Mental disease or psychological condition that impedes the subject from understanding the nature of the protocol and granting his/her consent. * Advanced dementia according to the Barthel index. * Active systemic infection. * History of primary or acquired immunodeficiency or on immunosuppressive therapy (within 3 months prior to inclusion or if the need for immunotherapy is foreseeable at any time during the study follow-up). * Tumour disease, except that eradicated at least 5 years prior to inclusion in the study and without receiving chest radiotherapy. Completely eradicated nonmelanoma skin tumours (at any time) not requiring chest chemotherapy or radiotherapy) are permitted. * History of autoimmune disease. * Stroke within 12 months prior to inclusion. * Respiratory compromise or need for home oxygen therapy. * Life expectancy of less than 1 year for any reason.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite safety endpoint formed by the major adverse cardiac and cerebrovascular events (MACCE) occurring on all visits during the first year after implantation. | During the first year after implantation | MACCE include: all-cause death, cardiovascular death, re-infarction, need for revascularization, hospitalization for heart failure, sustained ventricular tachycardia, ventricular fibrillation, or stroke. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in proinflammatory cytokines | During the first year after implantation | — |
| Changes in immunological cell types. | During the first year after implantation | — |
| Changes in the pericardial physiology | During the first year after implantation | Assessed by echocardiography or MRI |
| VT inducibility | During the first year after implantation | Heterogeneous tissue on MRI as well as the presence of late potentials on the electrophysiological study scheduled at 1 year of follow-up. |
| Incidence of all-cause death | During the first year after implantation | — |
| Incidence of cardiovascular death | During the first year after implantation | — |
| Incidence of re-infarction | During the first year after implantation | — |
| Incidence of need for revascularization | During the first year after implantation | — |
| Incidence of hospitalization for heart failure | During the first year after implantation | — |
| Incidence of sustained ventricular tachycardia | During the first year after implantation | — |
| Incidence of ventricular fibrillation | During the first year after implantation | — |
| Incidence of stroke | During the first year after implantation | — |
| Incidence of surgical complications | During the first year after implantation | — |
| Changes in end-systolic volume | During the first year after implantation | Measured by echocardiography comparing the baseline study of each patient with the studies performed in that same patient during the follow-up. |
| Changes in DSA-HLA | During the first year after implantation | — |
| Changes in left ventricular ejection fraction | During the first year after implantation | Measured by echocardiography comparing the baseline study of each patient with the studies performed in that same patient during the follow-up. |
| Changes in sphericity index | During the first year after implantation | Measured by echocardiography comparing the baseline study of each patient with the studies performed in that same patient during the follow-up. |
| Changes in segmental contraction score (normal / hypokinetic / akinetic / dyskinetic) in the 17 myocardial segments | During the first year after implantation | Measured by echocardiography comparing the baseline study of each patient with the studies performed in that same patient during the follow-up. |
| Changes in systolic thickening by myocardial segments | During the first year after implantation | Measured by echocardiography comparing the baseline study of each patient with the studies performed in that same patient during the follow-up. |
| Changes in the scar size expressed in grams | During the first year after implantation | Measured by MRI comparing the baseline study of each patient with the studies performed in that same patient during the follow-up. |
| Changes in the viable myocardial mass expressed in grams | During the first year after implantation | Measured by MRI comparing the baseline study of each patient with the studies performed in that same patient during the follow-up. |
| Changes in the scar size expressed in percentage of LV | During the first year after implantation | Measured by MRI comparing the baseline study of each patient with the studies performed in that same patient during the follow-up. |
| Changes in the percentage of viable myocardium in LV | During the first year after implantation | Measured by MRI comparing the baseline study of each patient with the studies performed in that same patient during the follow-up. |
| Changes in the functional class | During the first year after implantation | According to the New York Heart Association (NYHA) for dyspnea |
| Changes in the patient-perceived quality of life | During the first year after implantation | According to the Minnesota Living with Heart Failure Questionnaire (MLHFQ) |
| Changes in the distance covered on the 6-minute walk test | During the first year after implantation | — |
| Changes in the peak oxygen consumption on ergospirometry | During the first year after implantation | — |
| Changes in the brain natriuretic peptide | During the first year after implantation | — |
| Changes in end-diastolic volume | During the first year after implantation | Measured by echocardiography comparing the baseline study of each patient with the studies performed in that same patient during the follow-up. |
Countries
Spain
Contacts
Primary ContactAna Casado Plasencia
Backup ContactBlanca Jáuregui
Outcome results
None listed