Clinical trial NCT01144221: Bone Marrow Derived Mononuclear Cells for Ischemic Cardiomyopathy
Official title: Protocol on an Evaluative Study on Bone Marrow Derived Mononuclear Cells for Optimization of Biventricular Pacing in Patients With Chronic Ischemic Left Ventricular Dysfunction
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Heart Disease
Keywords: Chronic Ischemic Heart Disease
Lead sponsor: Asklepios proresearch
Sponsor class: INDUSTRY
First posted: 2010-06-15
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an evaluative, monocentric study in patients with chronic ischemic heart disease and left bundle branch block who received an ICD-CRT. It is an early investigation on the safety and effects of a single administration of bone marrow derived mononuclear cells after implantation of an ICD-CRT device as an adjunct to CRT and usual drug treatment.


Eligibility criteria: Inclusion Criteria:

* chronic left ventricular dysfunction (ejection fraction \<35 %) in chronic ischemic heart disease and asynchronic contraction with indication for a biventricular stimulation (CRT, chronic resynchronization therapy), who do not have an improvement of \>15% of LVEF 3 months after CRT-device implantation
* wall motion dysfunction of any territory
* left bundle branch block
* Patients were on individual optimal treatment for chronic ischemic heart disease with one or a combination of the following drug types: diuretics, ß-blockers, ACE-inhibitors, AT1 blockers and/or lipid lowering agents for at least 30 days before CRT Implantation

Exclusion Criteria:

* patients with left ventricular dysfunction due to other reasons than ischemic cardiomyopathy, e.g. hypertension, dilatative cardiomyopathy
* with relevant valvular disease;
* Aneurysma of the anterior myocardial wall or myocardial wall thickness of \< 5 mm,
* with overt heart failure, other than ischemic cardiomyopathy,
* with history of stroke and/or transient ischemic attack (TIA),
* with history of thromboembolic event (e.g. phlebothrombosis, pulmonary embolism), bleeding disorders and known disease of the coagulation system;
* with extensive deviations of baseline laboratory values and significant findings at physical examination which in the opinion of the investigator may worsen under treatment;
* with severe systemic disease - (e.g. known or suspected anaphylaxia, intolerance against X-ray or contrast agent and, pre-malignant and malignant disease)
* atrial fibrillation with average heart rate \>70 bpm
* pregnant women and women of childbearing potential who have not had a negative pregnancy test within 48 hours before treatment;
* with any disease or condition that seriously compromises the function of other body systems than the heart and/or might interfere with conduct of the study and interpretation of the results;
* patients with a chronic or acute HIV-, HBV-, HCV-infection;
* improvement of more than 15% of LVEF 3 months after CRT-device implantation
* patients who have a ICD Implantation for secondary prophylactic indication. These patients show a history of resuscitation, VT or syncope.
* patients who are currently participating in another investigational drug or device study

Primary outcomes:
measure: LVEF Value
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Asklepios Clinic St. Georg
Study officials:
affiliation: Asklepios proresearch
name: Korff Krause, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: