Primary Idiopathic Dilated Cardiomyopathy Clinical Trial
Official title:
Phase I/II Randomized Clinical Trial to Assess the Safety and Feasibility of Transendocardial Injection of Bone Marrow Autologous Mesenchymal Stem Cells in Patients With Idiopathic Dilated Cardiomyopathy.
The purpose of this study is to assess the safety, the feasibility and the efficacy of transendocardial injection of bone marrow-derived mesenchymal stem cells (MSCs) in patients with dilated idiopathic cardiomyopathy.
Status | Recruiting |
Enrollment | 70 |
Est. completion date | March 2018 |
Est. primary completion date | March 2018 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - II-III NYHA functional class, under optimal medical therapy. - LVEF = 20% and = 45% by echocardiography, SPECT or left ventriculogram one month prior to enrollment. - Anterior wall thickness = 8 mm by echocardiography or MRI one month prior to enrollment. - Idiopathic DCM diagnosis (having excluded CAD, valvular heart disease, cardiac toxic drugs, tachyarrhythmias, metabolic diseases, systemic diseases, infectious diseases) six months prior to enrollment. - Patients rejected for heart transplantation should have been discussed in the Heart Team at their respective centres, and a document stating the reason for exclusion will be kept in the medical record. - Able to exercise on a treadmill, MVO2 between = 12 and = 21 ml/Kg/min. - Hemodynamic stability (blood pressure > 100/40 mmHg, heart rate < 110 bpm and oxygen saturation > 95%). - Negative pregnancy test in women. - Signed informed consent Exclusion Criteria: - Evidence of secondary dilated cardiomyopathy causes: CAD, valvular heart disease, cardiac toxic drugs, tachyarrhythmias, metabolic diseases, systemic diseases, infectious diseases, myocarditis or postpartum ventricular dysfunction. - Permanent atrial fibrillation. - Candidates for ICD or CRT devices. Patients with theses devices can be enrolled if the device has been implanted at least 6 months before inclusion, and only if no-response has been observed to CRT. - Candidates for heart transplantation if surgery is anticipated in the next 2 years. - Left ventricular thrombus by echocardiography, MRI or left ventriculogram. - Peripheral artery disease that precludes cardiac catheterization with 8 Fr sheaths. . - Anterior wall thickness < 8 mm by echocardiography or MRI one month prior to enrollment. - Chronic renal failure (creatinine > 2,5 mg/dL). - I or IV NYHA functional class. Cardiogenic shock is defined as systolic blood pressure < 90 mmHg with no response to fluids, or < 100 mmHg with inotropes and without bradycardia. - Previous history of drug abuse (alcohol, etc…). - Acute or chronic infectious disease (including B/C hepatitis and HIV). - Pregnancy or child-bearing period. - MRI contraindications: pacemakers, ICD, metalic prosthesis, etc. - Bleeding or coagulation disorders (INR > 2 without anticoagulation treatment). - Cancer history 5 years prior to enrollment. - Life expectancy less than 1 year. - Any disease or condition that the investigator finds decisive for exclusion |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Spain | Hospital General Universitario Gregorio Marañón | Madrid | |
Spain | Hospital Clinico Universitario de Valladolid | Valladolid |
Lead Sponsor | Collaborator |
---|---|
Hospital General Universitario Gregorio Marañon | Ministerio de Sanidad, Servicios Sociales e Igualdad |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Major adverse cardiac adverse events. SAEs and AEs. | Major adverse cardiac adverse events includes cerebral adverse events | change from enrollment( 1, 3, 6, 12, 18 and 24 months) | Yes |
Primary | NYHA functional class. | Change from enrolment( 1, 3, 6, 12, 18, 24 months) | Yes | |
Primary | Incidence of complications with the use of NOGA XPTM catheters. | Change from enrolment( 1, 3, 6, 12, 18, 24 months) | Yes | |
Primary | Laboratory parameters including C-reactive protein an brain natriuretic peptide | Change from enrolment( 1, 3, 6, 12, 18, 24 months) | Yes | |
Secondary | NYHA Functional Class | 1, 3, 6, 12, 18, 24 months | No | |
Secondary | Max.oxygen consumption(MVO2),functional capacity. | 6,12,24 months | No | |
Secondary | Quality of life questionnaires | include 36-item Short Form Survey(SF 36) and Minnesota Living UIT Heart Failure questionnaire | 6,12 and 24 months | No |
Secondary | Extension. of perfusion defects(MRI/SPECT). | 6 and 24 months | No | |
Secondary | LVEF, ventricular vol.,wall motion score index(echocard./MRI/SPECT | 6,12 and 24 months | No | |
Secondary | LVEF(left ventriculogram, electromech. mapping parameters(NOGA XPTM)) | 12 months | No |