Malabsorption related dilated cardiomyopathy Circulatory System Cardiomyopathy
Conditions
Interventions
1. Intervention group: selenium and zinc i.v. administration (Addamel N 10 ml corresponding to Se 300 µg and Zn 13.6 mg)
2. Control group: no treatment
Patients will be randomly assigned to receive
Sponsors
La Sapienza University (Italy)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female patients aged 18 - 70 years with intestinal malabsorption due to intestinal bypass because of severe obesity 2. Dilated cardiomyopathy lasting more than 6 months unresponsive to conventional supportive therapy (ejection fraction [EF] less than 40%) 3. Patients consent to endomyocardial biopsy study before and after six months treatment 4. Serum and myocardial deficiency of selenium/zinc demonstrated by neutron activation analysis
Exclusion criteria
Exclusion criteria: 1. Patients with specific heart muscle diseases at histology (i.e. myocarditis) 2. Normal levels of myocardial trace elements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Improvement in heart failure symptoms as evaluated by New York Heart Association (NYHA) class 2. Improvement in cardiac dimension and function by echocardiography (ejection fraction, end diastolic diameter, end diastolic volume, diastolic function assessment) 3. Normalisation of the selenium/zinc levels at neutron activation analysis Primary and secondary outcome measures will be performed at baseline and after 6 months, i.e. at the end, of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Recovery of cardiomyocyte degeneration as evaluated at histology 2. Increase of glutathione peroxidase activity in myocardial tissue Primary and secondary outcome measures will be performed at baseline and after 6 months, i.e. at the end, of treatment. | — |
Countries
Italy
Outcome results
None listed