Here is the design of a clinical trial:

Official Title: Retrograde Application of Bone Marrow Aspirate Concentrate (BMAC) Through Coronary Sinus in Patients With Congestive Heart Failure of Ischemic Etiology

Included conditions:
- Heart Failure

Study Armgroups:
- {'label': 'Bone marrow autologous cells concentrate (BMAC)', 'type': 'EXPERIMENTAL', 'description': 'retrograde administration on non-selected BMAC via coronary sinus', 'interventionNames': ['Drug: BMAC']}
- {'label': 'Control', 'type': 'PLACEBO_COMPARATOR', 'description': 'standard treatment o heart failure', 'interventionNames': ['Drug: BMAC']}

Interventions:
- {'type': 'DRUG', 'name': 'BMAC', 'description': 'retrograde administration on non-selected BMAC via coronary sinus', 'armGroupLabels': ['Bone marrow autologous cells concentrate (BMAC)', 'Control']}

Primary Outcomes:
- {'measure': 'Left ventricular end-systolic diameter (LVESd)', 'description': 'Left ventricular end-systolic diameter', 'timeFrame': '12 month'}
- {'measure': 'Left ventricular end-systolic volume (LVESV)', 'description': 'Left ventricular end-systolic volume', 'timeFrame': '12 month'}
- {'measure': 'Left ventricular end-diastolic diameter (LVEDd)', 'description': 'Left ventricular end-diastolic diameter', 'timeFrame': '12 month'}
- {'measure': 'Left ventricular end-diastolic volume (LVEDV)', 'description': 'Left ventricular end-diastolic volume', 'timeFrame': '12 month'}
- {'measure': 'ejection fraction of left ventricle (EF LV)', 'description': 'ejection fraction of left ventricle', 'timeFrame': '12 month'}

Please estimate the sample size based on the assumption: 
Type I error (α) is 5%, test strength (β) is 80%, and an expected loss of 10% of patients in the 12-month follow-up. Continuous variables with normal distribution will be compared using Student's t-test, non-normal distribution using Mann-Whitney U test, and categorical variables using χ2 or Fisher exact test. Odds ratios (OR) are expressed with 95% CI, and a p-value < 0.05 is considered significant.
Sample size and statistical analysis
        The statistical estimate of the size of the file was based on the data from previous studies in patients with congestive heart failure [6] in which was reached the difference of 13.0â+â12.9âml in LVESV between study and control groups. Î± type I error of 5%, and Î² test strength of 80% were used to determine the required group size of 17 patients per group. When including an expected loss of 10% of patients in the 12-month follow-up (including MRI drop out), the resulting size of our group was 40 patients (20 per arm).
        Continuous variables with normal distribution will be presented as mean and standard deviation (SD) and will be compared using Student 2-sample t test. Continuous variables with non-normal distribution will be presented as the median and range (minimumâmaximum or lower and higher percentile) and will be compared using the nonparametric MannâWhitney U test. Categorical variables will be presented as counts and percentages and will be compared using the Ï2 or Fisher exact test. Odds ratios (OR) are expressed with 95% CI. A pâ<â0.05 will be considered significant. All statistical analyses will be performed using IBM SPSS Statistics version 22.