Selenium/zinc administration in human malabsorption cardiomyopathy

ISRCTN	ISRCTN18442853
DOI	https://doi.org/10.1186/ISRCTN18442853
Protocol serial number	N/A
Sponsor	La Sapienza University (Italy)
Funder	La Sapienza University (Italy)

Submission date: 15/10/2010
Registration date: 02/11/2010
Last edited: 02/11/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Andrea Frustaci
Scientific

Viale del Policlinico 155
Rome
00161
Italy

Phone	+39 065 51 70 575
Email	biocard@inmi.it

Study information

Primary study design	Interventional
Study design	Single centre randomised controlled clinical study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Randomised clinical trial on selenium/zinc administration in human malabsorption cardiomyopathy
Study objectives	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(s)	Ethics Committee of "La Sapienza" University of Rome approved on the 30th November 1997
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Selenium, Zinc
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	31/12/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	18
Key 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
Key exclusion criteria	1. Patients with specific heart muscle diseases at histology (i.e. myocarditis) 2. Normal levels of myocardial trace elements
Date of first enrolment	01/01/1998
Date of final enrolment	31/12/2010

Locations

Countries of recruitment

Italy

Study participating centre

Viale del Policlinico 155

Rome
00161
Italy

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes