NL-OMON47824
Recruiting
Phase 3
Stem Cell therapy in IschEmic Non-treatable Cardiac disease - SCIENCE - SCIENCE
Rigshospitalet Copenhagen University Hospital, Capital Region of Denmark0 sites20 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- ischaemic heart failure
- Sponsor
- Rigshospitalet Copenhagen University Hospital, Capital Region of Denmark
- Enrollment
- 20
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. 30 to 80 years of age
- •2\. Signed informed consent
- •3\. Chronic stable ischemic heart disease
- •4\. Symptomatic Heart failure (NYHA II\-III)
- •5\. LVEF \<\=45% on echocardiography, CT or MRI scan.
- •6\. Plasma NT\-pro\-BNP \> 300 pg/ml (\> 35 pmol/L)
- •7\. Maximal tolerable heart failure medication
- •8\. Medication unchanged two months prior to inclusion/signature of informed
- •consent. Changes in diuretics accepted.
- •9\. No option for percutaneous coronary intervention (PCI) or coronary artery
Exclusion Criteria
- •Exclusion criteria
- •1\. Heart Failure (NYHA I or IV)
- •2\. Acute coronary syndrome with elevation of CKMB or troponins, stroke or
- •transitory cerebral ischemia within six weeks of inclusion. Constant elevated
- •troponin due to renal failure, heart failure etc. do not exclude the patient.
- •3\. Other revascularisation treatment within four months of treatment
- •4\. If clinically indicated the patient should have a coronary angiography
- •before inclusion
- •5\. Moderate to severe aortic stenosis (valve area \< 1\.3 cm2\) or
- •valvular disease with option for surgery or interventional therapy.
Outcomes
Primary Outcomes
Not specified
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