Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2025-12-24 @ 7:16 PM
NCT ID:
NCT01005303
Eligibility Criteria:
Inclusion Criteria:
* New York Heart Association Class II and III
* Already on or tried on best known medical treatment (ACE inhibitor and beta-blocker)
* Stable for a period of at least 6 weeks
* Left ventricular ejection fraction less than or equal to 45%
Exclusion Criteria:
* History of significant alcohol ingestion (more than 40 units per week)
* Severe renal dysfunction (GFR less than 30ml/min)
* Severe hepatic dysfunction (known liver disease or transaminases greater than 3 times the upper limit of normal)
* Atrial fibrillation (in the absence of a pacemaker)
* Frequent ventricular ectopics
* On waiting list for cardiac transplantation
* Uncontrolled diabetes mellitus
* Inability to give informed consent
* Estimated life span less than 12 months
* Already taking a multivitamin/mineral supplement
* Already taking a vitamin-D containing fish oil
* Woman of child-bearing potential
* History of renal stones, hypercalcaemia, sarcoidosis, haemochromatosis or lactose intolerance
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01005303
Study Brief:
Protocol Section:
NCT01005303