Selenium/zinc administration in human malabsorption cardiomyopathy
| ISRCTN | ISRCTN18442853 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18442853 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Viale del Policlinico 155
Rome
00161
Italy
| Phone | +39 065 51 70 575 |
|---|---|
| biocard@inmi.it |
Study information
| Study design | Single centre randomised controlled clinical study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Selenium, Zinc |
| Primary outcome measure | 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 study start date | 01/01/1998 |
| Completion date | 31/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
00161
Italy
Sponsor information
La Sapienza University (Italy)
University/education
University/education
Viale del Policlinico 155
Rome
00161
Italy
| Phone | +39 064 99 70 785 |
|---|---|
| biocard@inmi.it | |
| Website | http://www.uniroma1.it |
"ROR" |
https://ror.org/02be6w209 |
Funders
Funder type
University/education
La Sapienza University (Italy)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
