Condition category
Circulatory System
Date applied
15/10/2010
Date assigned
02/11/2010
Last edited
02/11/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Andrea Frustaci

ORCID ID

Contact details

Viale del Policlinico 155
Rome
00161
Italy
+39 065 51 70 575
biocard@inmi.it

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Randomised clinical trial on selenium/zinc administration in human malabsorption cardiomyopathy

Acronym

Study hypothesis

Intestinal malabsorption is associated with trace elements deficiency and cardiomyopathy. The study will test the efficacy of selenium/zinc intravenous (i.v.) administration in reverting the malabsorption associated cardiac dilation and dysfunction.

Ethics approval

Ethics Committee of "La Sapienza" University of Rome approved on the 30th November 1997

Study design

Single centre randomised controlled clinical study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Malabsorption related dilated cardiomyopathy

Intervention

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 standard anti-heart failure therapy alone or associated with i.v. selenium and zinc administration every day for 1 week and every week for 6 months.

Intervention type

Drug

Phase

Not Applicable

Drug names

Selenium, Zinc

Primary outcome measures

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 outcome measures

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.

Overall trial start date

01/01/1998

Overall trial end date

31/12/2010

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

18

Participant exclusion criteria

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

Recruitment start date

01/01/1998

Recruitment end date

31/12/2010

Locations

Countries of recruitment

Italy

Trial participating centre

Viale del Policlinico 155
Rome
00161
Italy

Sponsor information

Organisation

La Sapienza University (Italy)

Sponsor details

Viale del Policlinico 155
Rome
00161
Italy
+39 064 99 70 785
biocard@inmi.it

Sponsor type

University/education

Website

http://www.uniroma1.it

Funders

Funder type

University/education

Funder name

La Sapienza University (Italy)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes