Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-25 @ 2:06 AM
NCT ID:
NCT03572660
Eligibility Criteria:
Inclusion Criteria:
* Patients with a confirmed diagnosis of dilated cardiomyopathy under the supervision of a physician or a heart failure nurse specialist.
* NYHA class ≥ 2 symptoms despite having received optimal medical therapy and appropriate device therapy, as per clinical guidelines for an interval of at least 3 months.
* No other treatment options available as part of the current best standard of care.
* LVEF ≤35% on any imaging modality performed as part of the screening phase.
Exclusion Criteria:
* Congenital heart disease.
* Clinically significant valvular heart disease.
* Patients who are not suitable for a Percutaneous Mechanical Support Device (E.g. unsuitable femoral artery anatomy, unable able to lie flat for prolonged time to accommodate the stem cell infusion \& presence of LV thrombus)
* Weight of patient that exceeds the maximum limit of the cardiac catheterisation laboratory table / CT scanner.
* Cardiomyopathy 2o to a reversible cause that has not been treated e.g. thyroid disease, alcohol abuse, hypophosphataemia, hypocalcaemia, cocaine abuse, selenium toxicity \& chronic uncontrolled tachycardia.
* Cardiomyopathy in association with a neuromuscular disorder e.g. Duchenne's progressive muscular dystrophy.
* Previous cardiac surgery.
* Contra-indication for bone marrow aspiration (thrombocytopaenia - platelet count \<80 x 10(9)/L or extensive surgical scarring/anatomical deformity at site of bone marrow puncture).
* Known active infection on admission as defined by a temperature \>37.5°C or on a short course of antibiotics.
* An active infection of hepatitis B, hepatitis C, syphilis or HTLV
* Known HIV infection
* Chronic inflammatory disease requiring on-going medication.
* Concomitant disease with a life expectancy of less than one year
* Follow-up impossible (no fixed abode, etc.)
* Neoplastic disease without documented remission within the past 5 years.
* Patients on renal replacement therapy.
* Subjects of childbearing potential unless βHCG negative and are on adequate contraception during the trial.
* Patients falling into the vulnerable category or lacking capacity
* Patients who are unable to understand or read written English will be excluded from the trial.
* Killip Class III or above
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT03572660
Study Brief:
Protocol Section:
NCT03572660