Heart Failure With Reduced Ejection Fraction Clinical Trial
— CARDIOMESHOfficial title:
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.
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.
Status | Recruiting |
Enrollment | 10 |
Est. completion date | October 30, 2020 |
Est. primary completion date | October 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital General Universitario Gregorio Marañón | Madrid | |
Spain | Clínica Universidad de Navarra | Pamplona | Navarra |
Lead Sponsor | Collaborator |
---|---|
Viscofan | Ministerio de Ciencia e Innovación, Spain |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Composite safety endpoint formed by the major adverse cardiac and cerebrovascular events (MACCE) occurring on all visits 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. | During the first year after implantation | |
Secondary | Incidence of all-cause death | During the first year after implantation | ||
Secondary | Incidence of cardiovascular death | During the first year after implantation | ||
Secondary | Incidence of re-infarction | During the first year after implantation | ||
Secondary | Incidence of need for revascularization | During the first year after implantation | ||
Secondary | Incidence of hospitalization for heart failure | During the first year after implantation | ||
Secondary | Incidence of sustained ventricular tachycardia | During the first year after implantation | ||
Secondary | Incidence of ventricular fibrillation | During the first year after implantation | ||
Secondary | Incidence of stroke | During the first year after implantation | ||
Secondary | Incidence of surgical complications | During the first year after implantation | ||
Secondary | Changes in the pericardial physiology | Assessed by echocardiography or MRI | During the first year after implantation | |
Secondary | VT inducibility | Heterogeneous tissue on MRI as well as the presence of late potentials on the electrophysiological study scheduled at 1 year of follow-up. | During the first year after implantation | |
Secondary | Changes in DSA-HLA | During the first year after implantation | ||
Secondary | Changes in proinflammatory cytokines | During the first year after implantation | ||
Secondary | Changes in immunological cell types. | During the first year after implantation | ||
Secondary | Changes in end-systolic volume | Measured by echocardiography comparing the baseline study of each patient with the studies performed in that same patient during the follow-up. | During the first year after implantation | |
Secondary | Changes in end-diastolic volume | Measured by echocardiography comparing the baseline study of each patient with the studies performed in that same patient during the follow-up. | During the first year after implantation | |
Secondary | Changes in left ventricular ejection fraction | Measured by echocardiography comparing the baseline study of each patient with the studies performed in that same patient during the follow-up. | During the first year after implantation | |
Secondary | Changes in sphericity index | Measured by echocardiography comparing the baseline study of each patient with the studies performed in that same patient during the follow-up. | During the first year after implantation | |
Secondary | Changes in segmental contraction score (normal / hypokinetic / akinetic / dyskinetic) in the 17 myocardial segments | Measured by echocardiography comparing the baseline study of each patient with the studies performed in that same patient during the follow-up. | During the first year after implantation | |
Secondary | Changes in systolic thickening by myocardial segments | Measured by echocardiography comparing the baseline study of each patient with the studies performed in that same patient during the follow-up. | During the first year after implantation | |
Secondary | Changes in the scar size expressed in grams | Measured by MRI comparing the baseline study of each patient with the studies performed in that same patient during the follow-up. | During the first year after implantation | |
Secondary | Changes in the viable myocardial mass expressed in grams | Measured by MRI comparing the baseline study of each patient with the studies performed in that same patient during the follow-up. | During the first year after implantation | |
Secondary | Changes in the scar size expressed in percentage of LV | Measured by MRI comparing the baseline study of each patient with the studies performed in that same patient during the follow-up. | During the first year after implantation | |
Secondary | Changes in the percentage of viable myocardium in LV | Measured by MRI comparing the baseline study of each patient with the studies performed in that same patient during the follow-up. | During the first year after implantation | |
Secondary | Changes in the functional class | According to the New York Heart Association (NYHA) for dyspnea | During the first year after implantation | |
Secondary | Changes in the patient-perceived quality of life | According to the Minnesota Living with Heart Failure Questionnaire (MLHFQ) | During the first year after implantation | |
Secondary | Changes in the distance covered on the 6-minute walk test | During the first year after implantation | ||
Secondary | Changes in the peak oxygen consumption on ergospirometry | During the first year after implantation | ||
Secondary | Changes in the brain natriuretic peptide | During the first year after implantation |
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