Selenium/zinc administration in human malabsorption cardiomyopathy

Completed

Conditions: Malabsorption related dilated cardiomyopathy
Circulatory System
Cardiomyopathy

Registration Number: ISRCTN18442853

Lead Sponsor: a Sapienza University (Italy)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 18

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

1. Patients with specific heart muscle diseases at histology (i.e. myocarditis)
2. Normal levels of myocardial trace elements

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Improvement in heart failure symptoms as evaluated by New York Heart Association (NYHA) class<br>2. Improvement in cardiac dimension and function by echocardiography (ejection fraction, end diastolic diameter, end diastolic volume, diastolic function assessment)<br>3. Normalisation of the selenium/zinc levels at neutron activation analysis<br><br>Primary and secondary outcome measures will be performed at baseline and after 6 months, i.e. at the end, of treatment.

Secondary Outcome Measures

Name	Time	Method
1. Recovery of cardiomyocyte degeneration as evaluated at histology<br>2. Increase of glutathione peroxidase activity in myocardial tissue<br><br>Primary and secondary outcome measures will be performed at baseline and after 6 months, i.e. at the end, of treatment.