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Table 1 Eligibility criteria

From: Randomised, double-blind, placebo-controlled clinical trial for evaluating the efficacy of intracoronary injection of autologous bone marrow mononuclear cells in the improvement of the ventricular function in patients with idiopathic dilated myocardiopathy: a study protocol

INCLUSION CRITERIA

Participants meeting all the following criteria will be included:

  1. Male and female patients between 18 and 70 years old.

  2. Patients who sign the informed consent.

  3. Patient diagnosed with idiopathic dilated cardiomyopathy (using echocardiography).

  4. At least 6 months since dilated cardiomyopathy diagnosis.

  5. Lack of coronary injuries on multi-slice computerized axial tomography scan and/or hemodynamic study performed after the inclusion of the patient in the trial, or prior to recruitment if the patient does not present any angina symptomatology.

  6. Patients under optimised pharmacological treatment for at least 6 months prior inclusion in the trial.

  7. Left ventricular ejection fraction (LVEF) ≤ 40% or LVEF 40–50% if left ventricular end diastolic volume (LVEDV) > 110 ml/m2 (measured by echocardiogram).

  8. Presence of sinus rhythm.

  9. Normal levels of analytic indicators. Defined by: Leukocytes ≥3000c cel/mm3; Neutrophils ≥1500 cel/mm3; Platelets ≥100,000 cel/mm3; AST/ALT ≤2.5 institution standard range; Creatinine ≤2.5 mg/dl.

  10. Woman of childbearing age with a negative result on a pregnancy test performed at the time of the inclusion and committed to use contraceptive methods during the study.

EXCLUSION CRITERIA

Participants meeting one or more of the following criteria will be excluded.

  1. Secondary dilated cardiomyopathy

  2. Recent (6 months) myocarditis episodes prior to signing the informed consent.

  3. Patients susceptible to resynchronization therapy (QRS > 150, presenting symptoms and with no response to medication). However non-responders to resynchronization therapy within 6 months may be included.

  4. Patients in the waiting list for cardiac transplantation.

  5. Coexistence of any type of hematologic disorder, malignant or premalignant tumor, or other severe systemic diseases.

  6. Woman of childbearing age not using contraceptives, pregnant or in breastfeeding period.

  7. Patients currently taking part in another clinical trial or those who did so in the last 3 months or those who have participated in a clinical trial with advanced therapy at any time.

  8. Positive serology for hepatitis B, hepatitis C or human immunodeficiency virus.

  9. Patients taking medicines prohibited by protocol at the time of inclusion. A wash-out period of 2 months is established to be eligible for inclusion.